Codman & Shurtleff, Inc.
Medical device manufacturer in Raynham, MA.
152510(k) clearances
0PMA approvals
75recalls
Device types
- JXG Shunt, Central Nervous System And Components 23
- GWM Device, Monitoring, Intracranial Pressure 9
- DQY Catheter, Percutaneous 8
- HCG Device, Neurovascular Embolization 7
- HBF Drills, Burrs, Trephines & Accessories… 6
- GEI Electrosurgical, Cutting & Coagulation &… 5
- HBL Holder, Head, Neurosurgical (Skull Clamp) 5
- GZJ Stimulator, Nerve, Transcutaneous, For Pain… 4
- HCH Clip, Aneurysm 4
- JDG Prosthesis, Hip, Femoral Component… 4
- GWG Endoscope, Neurological 3
- HCA Catheter, Ventricular 3
- GEX Powered Laser Surgical Instrument 3
- KPM Shunt, Peritoneal 3
- JEY Plate, Bone 3
- JDQ Cerclage, Fixation 3
- GCY Apparatus, Suction, Single Patient Use… 3
- HNN Knife, Ophthalmic 2
- HBM Headrest, Neurosurgical 2
- HAO Instrument, Surgical, Non-Powered 2
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K193380 | CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetNRY · Traditional | 07/20/2020SE |
| K191237 | CERENOVUS Large Bore CatheterDQY · Traditional | 11/08/2019SE |
| K173192 | CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP…GWM · Special | 11/08/2017SE |
| K172537 | Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System…JXG · Traditional | 10/16/2017SE |
| K172022 | CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)JXG · Traditional | 10/03/2017SE |
| K171862 | GALAXY G3 Mini Microcoil Delivery SystemHCG · Traditional | 09/25/2017SE |
| K171747 | MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch…HCG · Special | 07/14/2017SE |
| K171653 | YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back UpDQY · Special | 07/03/2017SE |
| K162563 | YOGA MicrocatheterDQY · Special | 01/05/2017SE |
| K162437 | Codman EDS3 CSF External Drainage SystemJXG · Traditional | 10/28/2016SE |
| K153347 | Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman…GWM · Traditional | 08/19/2016SE |
| K152481 | DURAFORM Dural Graft ImplantGXQ · Special | 10/30/2015SE |
| K150319 | Micrusframe 10/18, Deltafill 18, Deltaxsft 10, Galaxy G3 Fill/Xsft Stretch Resistant…HCG · Traditional | 06/12/2015SE |
| K142429 | CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2…HCG · Special | 12/24/2014SE |
| K140080 | Envoy Distal Access (Da) Guiding Catheter, 6F, 95CM & 105CM, Straight & XB, MPD & XB…DQY · Special | 04/24/2014SE |
| K140307 | Envoy Guiding CatheterDQY · Special | 04/21/2014SE |
| K133625 | Agility 10 Standard & Soft 0.01IN. X 195CM, Agility 14 Standard & Soft 0.014IN X 205CM &…MOF · Special | 02/24/2014SE |
| K132281 | ReVive PV (Peripheral Vasculature) Thrombectomy DeviceQEW · Special | 08/30/2013SE |
| K123560 | Vascular Occlusion System (Trufill Pushable Coils), and Trufill DCS Orbit Detachable…HCG · Special | 01/25/2013SE |
| K121776 | Agility Steerable Guidewire Neuroscout Steerable GudiewireDQX · Traditional | 08/14/2012SE |
| K122118 | Hakim Programmable and Precision Valve Shunt SystemJXG · Special | 08/03/2012SE |
| K120117 | Codman Quad-Lock Sterilization Container SystemKCT · Traditional | 04/16/2012SE |
| K120686 | Orbit Galaxy G2 Microcoil Delivery SystemHCG · Special | 04/04/2012SE |
| K120229 | Envoy Distal Access Guiding CatheterDQY · Special | 02/24/2012SE |
| K112828 | Revive Intermediate Catheter (Revive Ic)DQY · Special | 10/25/2011SE |
| K110751 | Codman Bactiseal Endoscopic Venticular CatheterJXG · Traditional | 05/09/2011SE |
| K102961 | Holter In-Line Shunt Filter, Holter Cerebral Catheter Reservoir, Accu-Flo Connectors…JXG · Special | 02/18/2011SE |
| K102589 | Codman Bactiseal Catheters, Codman Bactiseal Evd CatheterJXG · Special | 01/14/2011SE |
| K093973 | Trufill DCS Orbit Detachable Coil SystemHCG · Traditional | 05/26/2010SE |
| K092437 | Codman Sterilization ContainersKCT · Traditional | 03/25/2010SE |
| K100351 | Neuroscout Steerable GuidewireDQX · Special | 03/16/2010SE |
| K093184 | Envoy Guiding CathetersDQY · Special | 11/06/2009SE |
| K091921 | Codman Aneurysm Clips, Codman Avm Micro Clip System, Codman Slim-Line Graft…HCH · Special | 09/08/2009SE |
| K083895 | Codman Isocool Bipolar ForcepsGEI · Traditional | 06/23/2009SE |
| K091346 | Codman Hakim Micro II ValveJXG · Special | 06/02/2009SE |
| K090348 | Codman Bactiseal Evd Catheter Set, Codman Bactiseal Clear Evd Catheter SetJXG · Special | 03/04/2009SE |
| K073336 | Codman Craniotomy Kit, Models 26-1229, 26-1230, 26-1231HBF · Special | 01/04/2008SE |
| K071931 | Codman Disposable Perforator, Model(S) 26-1222, 26-1223HBF · Traditional | 10/22/2007SE |
| K071791 | Modification to Cranioplastic, Model 43-1280GXP · Special | 07/30/2007SE |
| K071776 | Aneuroplastic, Model 43-1290JXH · Special | 07/26/2007SE |
| K061876 | Codman VPV System, Model 82-3192JXG · Traditional | 10/16/2006SE |
| K061568 | Codman Eds 3 CSF External Drainage System, Models 82-1730, 82-1731, 82-1732, 82-1733…JXG · Special | 09/29/2006SE |
| K053350 | Modification to Codman Hakim Shunt SystemsJXG · Special | 01/19/2006SE |
| K053107 | Codman Hakim Programmable Valve W/Wo SiphonguardJXG · Special | 01/19/2006SE |
| K052449 | Cadman Integrated Irrigation Tubing and Bipolar Cord Set, Models 80-1163, 80-1189GEI · Traditional | 10/17/2005SE |
| K050739 | Codman VPV System, Model 82-3192JXG · Traditional | 07/18/2005SE |
| K041518 | Codman Duraform Dural Graft ImplantGXQ · Special | 06/22/2004SE |
| K041296 | Modification to Hakim Precision Valve System, Hakim Programmable Valve System, Hakim…JXG · Special | 06/10/2004SE |
| K033395 | Codman Dural Graft Implant, Models 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476…GXO · Traditional | 02/25/2004SE |
| K023566 | Codman Isocool Bipolar ForcepsGEI · Traditional | 05/22/2003SE |
| K031123 | Codman Bactiseal Barium Striped CathetersHCA · Special | 05/14/2003SE |
| K021653 | Codman Bactiseal Evd Catheter SetJXG · Traditional | 07/29/2002SE |
| K020667 | Codman Hakim Shunt SystemsJXG · Special | 03/28/2002SE |
| K013877 | Codman Slim-Loc SystemKWQ · Special | 12/19/2001SE |
| K003322 | Codman Bactiseal CathetersHCA · Traditional | 10/01/2001SE |
| K003549 | Codman Craniosorb Absorbable Fixation System Purple RivetsJEY · Traditional | 02/15/2001SE |
| K003564 | Hakim Programmer and TransmitterJXG · Special | 12/20/2000SE |
| K002798 | Codman Craniosorb Absorbable Fixation System Drill BitsJEY · Traditional | 12/06/2000SE |
| K992905 | Codman Craniosorb Absorbable Fixation SystemJEY · Traditional | 08/01/2000SE |
| K992591 | Codman Single and Double Lumen Skull Bolt KitsGWM · Traditional | 10/15/1999SE |
| K953568 | Codman Fiducial Marker SystemHAW · Traditional | 02/29/1996SE |
| K944612 | Acustar I Advanced Surgical Navigation SystemLLZ · Traditional | 12/11/1995SE |
| K912456 | Sundt Slim-Line Graft ClipsHCH · Traditional | 03/10/1995SE |
| K934756 | Codman Anterior Cervical Spine Plate SystemKWQ · Traditional | 11/08/1994SE |
| K934196 | Codman Quick Shunt Kit, Cat. #82-6570GWG · Traditional | 04/12/1994SE |
| K914479 | Microsensor Intracranial Pressure TransducerGWM · Traditional | 03/07/1994SE |
| K933894 | Disposable PerforatorHBF · Traditional | 12/10/1993SE |
| K924977 | Codman Laser NeuroendoscopeGWG · Traditional | 11/22/1993SE |
| K931281 | Micro Endoscopic Electrode (ME2)GCJ · Traditional | 07/23/1993SE |
| K924242 | Disposable PerforatorHBF · Traditional | 07/08/1993SE |
| K924142 | Codman(Tm) Titanium Interlaminar Clamp KitKWP · Traditional | 06/15/1993SE |
| K923869 | Codman Sof'Wire Titanium Cable SystemJDQ · Traditional | 05/12/1993SE |
| K926116 | Codman Sofwire(Tm) KitJDQ · Traditional | 03/30/1993SE |
| K923555 | Codman Gaab NeuroendoscopeGWB · Traditional | 03/23/1993SE |
| K920979 | Codman Steerable Endoscope (Cat.# 83-1340)GCQ · Traditional | 03/23/1993SE |
| K923646 | Codman Endoflex Grasping and Biopsy ForcepsGWG · Traditional | 12/21/1992SE |
| K913987 | OR340 Intraoperative Ultrasound Biopsy Needle GuidITY · Traditional | 04/13/1992SE |
| K915581 | Codman Sof'Wire (TM) KitJDQ · Traditional | 01/16/1992SE |
| K912005 | Codman Skull Pins (Adult & Child), ReusableHBL · Traditional | 09/19/1991SE |
| K911723 | Codman Disposable Skull PinsHBL · Traditional | 09/10/1991SE |
| K913170 | Codman Skull ClampHBL · Traditional | 09/06/1991SE |
| K911772 | Gardner Pins (Adult & Child)HBL · Traditional | 08/26/1991SE |
| K910938 | Codman External Drainage System II (Eds II)JXG · Traditional | 08/16/1991SE |
| K913233 | Codman Lhalo Split Ring Retractor SystemGZT · Traditional | 07/31/1991SE |
| K912011 | Codman Skull ClampHBL · Traditional | 07/31/1991SE |
| K911918 | Swivel Horseshoe HeadrestHBM · Traditional | 07/17/1991SE |
| K911917 | Codman Pediatric Horseshoe HeadrestHBM · Traditional | 07/17/1991SE |
| K905433 | Codman Disposable Scalp Clip ApplierHBO · Traditional | 02/21/1991SE |
| K904352 | Codman Collins Radioparent Sternal BladesDWH · Traditional | 11/21/1990SE |
| K904120 | Accu-Flo* Unitized ShuntJXG · Traditional | 10/09/1990SE |
| K900881 | OR-340 Intraoperative Ultrasound SystemIYO · Traditional | 09/25/1990SE |
| K902544 | Sundt Avm Micro ClipHCI · Traditional | 09/20/1990SE |
| K902257 | Codman* External Drainage System II (Eds-Ii)JXG · Traditional | 07/19/1990SE |
| K901937 | Codman Suction PattieGCX · Traditional | 07/16/1990SE |
| K894778 | Codman RF-12 Disposable Scalp Clip ApplierHBO · Traditional | 12/06/1989SE |
| K894756 | Denver Peritoneo-Venus ShuntKPM · Traditional | 09/29/1989SE |
| K892215 | Uni-Shunt(Tm) with Elliptical Reservoir KitJXG · Traditional | 08/21/1989SE |
| K883607 | Peel-Away Introducer for Ventricular CatheterGYK · Traditional | 09/30/1988SE |
| K880570 | Denver Pleuro-Peritoneal ShuntKPM · Traditional | 06/20/1988SE |
| K880401 | Denver Peritoneo-Venous ShuntKPM · Traditional | 05/31/1988SE |
| K880402 | Codman Surgical PattieHBA · Traditional | 03/02/1988SE |
| K872179 | Codman Neurolase Laser SystemGEX · Traditional | 10/07/1987SE |
| K871978 | Codman Flexible EndoscopeGCQ · Traditional | 08/25/1987SE |
| K870399 | Selverstone Clamp Salibi ClampHCE · Traditional | 03/06/1987SE |
| K855247 | Interoperative Linear/Sector Ultrasound ScannerITX · Traditional | 02/19/1987SE |
| K853770 | Codman Disposable Plastic Intracranial Press/KitGWM · Traditional | 10/06/1986SE |
| K853627 | Codman Laser RodsGEX · Traditional | 02/07/1986SE |
| K853626 | Codman Laser BackstopGEX · Traditional | 02/07/1986SE |
| K853215 | Accu-Flo Pressure ValveJXG · Traditional | 09/16/1985SE |
| K853066 | Mayfield Disposable Skull PinsHAX · Traditional | 08/08/1985SE |
| K851229 | Codman ArthroscopeHRX · Traditional | 05/22/1985SE |
| K851487 | Codman Disposable Bipolar CardGEI · Traditional | 05/03/1985SE |
| K844213 | Stimtech SD Patient 6089 #78-8050GZJ · Traditional | 01/10/1985SE |
| K844212 | Stimtech SD Clinician 6090 #78-8055GZJ · Traditional | 01/10/1985SE |
| K844553 | Micra Diamond Knife Micra Adjustable KnifeHNN · Traditional | 12/11/1984SE |
| K842774 | Codman Suction Punch-Product CodesHTZ · Traditional | 07/27/1984SE |
| K840964 | SD Plus Clinician Cat# 78-8015GZJ · Traditional | 04/23/1984SE |
| K840963 | SD Plus Patient CAT.#78-8010GZJ · Traditional | 04/23/1984SE |
| K834477 | Dispos. Scott Cannulas 16-1054 Etc.HCA · Traditional | 03/19/1984SE |
| K840003 | Disposable Icp Kit Diff. SizesGWM · Traditional | 02/28/1984SE |
| K833015 | Bioplar Cord -Disposable 30-1538GEI · Traditional | 10/14/1983SE |
| K820087 | Codman * Reusable PerforatorHBF · Traditional | 02/04/1982SE |
| K813123 | Epc FilterDRR · Traditional | 11/27/1981SE |
| K802138 | Cheek Tool SetGWM · Traditional | 10/31/1980SE |
| K802137 | Cheek Epidural ScrewGWM · Traditional | 10/31/1980SE |
| K791765 | Masterson* Endometrial Biopsy KitHHK · Traditional | 11/05/1979SE |
| K791764 | Scoville-Lewis Aneurysm ClipsHCH · Traditional | 10/01/1979SE |
| K791978 | Sugita Aneurysm Clips, Appliers & Case · Traditional | 09/28/1979SESP |
| K791101 | Disposable Perforators, Jacobs, HudsonHBF · Traditional | 08/28/1979SE |
| K790920 | Intracranial Pressure MonitoringGWM · Traditional | 08/03/1979SE |
| K781452 | Baylow Visual Acuity TesterHOX · Traditional | 10/24/1978SE |
| K781412 | Oscillating Knife and AccessoriesHMY · Traditional | 10/11/1978SE |
| K781465 | Microsurgical Knives, 20, 30, 45HNN · Traditional | 09/20/1978SE |
| K781411 | Corneal Cutter and AccessoriesHRH · Traditional | 09/20/1978SE |
| K771026 | Huang Vein Holder, #21-8011DWS · Traditional | 06/20/1977SE |
| K770498 | Preserve Lubricant Code No. 43=4035KMJ · Traditional | 06/20/1977SE |
| K770389 | Lens Set, Mentor TrialHPC · Traditional | 03/14/1977SE |
| K761161 | 67-8006 Darling-Linton Aortic Tourn.DWS · Traditional | 12/06/1976SE |
| K761097 | Vanderbilt Blade HolderHAO · Traditional | 11/30/1976SE |
| K761096 | Vanderbilt Pituitary RetractorGAD · Traditional | 11/30/1976SE |
| K761095 | Vanderbilt CuretteHAO · Traditional | 11/30/1976SE |
| K761003 | Charnley Congenital Hip Femur (85-3061)JDG · Traditional | 11/23/1976SE |
| K761002 | Charnley Congenital Hip Femur (85-3060)JDG · Traditional | 11/23/1976SE |
| K760977 | Charnley Femur Drill #1 and #2HWE · Traditional | 11/16/1976SE |
| K760976 | Charnley Revision SetJDG · Traditional | 11/16/1976SE |
| K760974 | Charnley Femoral ComponentJDG · Traditional | 11/16/1976SE |
| K760961 | Occlusion ClipsHCH · Traditional | 11/12/1976SE |
| K760747 | Yasargil Suction Tube - MediumGCY · Traditional | 11/01/1976SE |
| K760746 | Yasargil Suction Tube - LargeGCY · Traditional | 11/01/1976SE |
| K760745 | Yasargil Suction Tube - SmallGCY · Traditional | 11/01/1976SE |
| K760771 | Sola Schultze-Crock OpthalmoscopeHLJ · Traditional | 10/15/1976SE |
| K760770 | Sola Commido LoupeHLJ · Traditional | 10/15/1976SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2280-2019 Class II | GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm).Incorrect coil length on the label | 05/16/2019Terminated |
| Z-1572-2014 Class II | MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The MedStream…A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life. | 11/10/2015Terminated |
| Z-1571-2014 Class II | MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStream…A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life. | 11/10/2015Terminated |
| Z-1684-2015 Class II | CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000…Needle is leaking from hub/needle cannula connection | 03/05/2015Terminated |
| Z-0091-2015 Class II | Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog…tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or… | 09/15/2014Terminated |
| Z-0090-2015 Class II | Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage System)…tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or… | 09/15/2014Terminated |
| Z-0089-2015 Class II | Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System)…tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or… | 09/15/2014Terminated |
| Z-2191-2014 Class II | Codman Certas - In Line Valve with SIPHONGUARD Device, Unitized BACTISEAL Catheter and…To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's… | 07/03/2014Terminated |
| Z-2190-2014 Class II | Codman Certas - In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories…To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's… | 07/03/2014Terminated |
| Z-2189-2014 Class II | Codman Certas - In Line Valve with SIPHONGUARD Device, Catheter and Accessories; Product…To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's… | 07/03/2014Terminated |
| Z-2188-2014 Class II | Codman Certas - In Line Valve only with SIPHONGUARD Device; Product Code: 82-8804 The…To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's… | 07/03/2014Terminated |
| Z-2187-2014 Class II | Codman Certas - In line Valve with Unitized BACTISEAL Catheter and Accessories; Product…To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's… | 07/03/2014Terminated |
| Z-2186-2014 Class II | Codman Certas - In Line Valve with Unitized Catheter and Accessories; Product Code:…To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's… | 07/03/2014Terminated |
| Z-2185-2014 Class II | Codman Certas - In Line Valve with Catheter and Accessories; Product Code: 82-8801 The…To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's… | 07/03/2014Terminated |
| Z-2184-2014 Class II | Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas Programmable…To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's… | 07/03/2014Terminated |
| Z-1468-2014 Class II | CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows:…Ensuring all customers have the tools to assist in verifying the setting of the valve on x-ray images and… | 12/13/2013Terminated |
| Z-0789-2014 Class I | TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one…Incorrect instructions for use (IFU). | 10/11/2013Terminated |
| Z-0788-2014 Class I | TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one…Incorrect instructions for use (IFU). | 10/11/2013Terminated |
| Z-2300-2013 Class I | MedStream Programmable Pump; 20ml Pump EMEA 91-4200 Product Usage: The Medstream…Drug flow rates exceeding programmed flow rates. | 08/13/2013Terminated |
| Z-2299-2013 Class I | MedStream Programmable Pump; 40ml Pump EMEA 91-4201 Product Usage: The Medstream…Drug flow rates exceeding programmed flow rates. | 08/13/2013Terminated |
| Z-2298-2013 Class I | MedStream Refill Kit, U.S (6 units): 91-4288 Product Usage: The Medstream programmable…Drug flow rates exceeding programmed flow rates. | 08/13/2013Terminated |
| Z-2297-2013 Class I | MedStream Refill Kit (6 units), EMEA: 91-4290 Product Usage: The Medstream programmable…Drug flow rates exceeding programmed flow rates. | 08/13/2013Terminated |
| Z-2296-2013 Class I | MedStream Refill Kit (1 unit), EMEA: 91-4289 Product Usage: The Medstream programmable…Drug flow rates exceeding programmed flow rates. | 08/13/2013Terminated |
| Z-2295-2013 Class I | MedStream Refill Kit, U.S: 91-4287 Product Usage: The Medstream programmable pump is…Drug flow rates exceeding programmed flow rates. | 08/13/2013Terminated |
| Z-2294-2013 Class I | MedStream Programmable Pump; 40ml - 91-4201US Usage: The Medstream programmable pump is…Drug flow rates exceeding programmed flow rates. | 08/13/2013Terminated |
| Z-2293-2013 Class I | MedStream Programmable Pump; 20ml - 91-4200US Product Usage: The Medstream programmable…Drug flow rates exceeding programmed flow rates. | 08/13/2013Terminated |
| Z-1691-2013 Class I | MedStream Programmable Infusion Pump , Implantable for the intrathecal delivery of…Miscalibrated Fill Level Sensor may affect dosing level | 06/07/2013Terminated |
| Z-1690-2013 Class I | MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of…Miscalibrated Fill Level Sensor may affect dosing level | 06/07/2013Terminated |
| Z-0864-2014 Class II | Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Unitized…Codman Certas Programmable Valves used for hydrocephalus may not operate properly | 05/16/2013Terminated |
| Z-0863-2014 Class II | Codman Certas Programmable Valve In Line Valve with Siphonguard, Unitized Catheter and…Codman Certas Programmable Valves used for hydrocephalus may not operate properly | 05/16/2013Terminated |
| Z-0862-2014 Class II | Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Catheter and…Codman Certas Programmable Valves used for hydrocephalus may not operate properly | 05/16/2013Terminated |
| Z-0861-2014 Class II | Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device Product…Codman Certas Programmable Valves used for hydrocephalus may not operate properly | 05/16/2013Terminated |
| Z-0860-2014 Class II | Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and…Codman Certas Programmable Valves used for hydrocephalus may not operate properly | 05/16/2013Terminated |
| Z-0859-2014 Class II | Codman Certas Programmable Valve In Line Valve with Catheter and Accessories Product…Codman Certas Programmable Valves used for hydrocephalus may not operate properly | 05/16/2013Terminated |
| Z-0858-2014 Class II | Codman Certas Programmable Valve In Line Valve Only Product Code: 82-8800 Product Usage:…Codman Certas Programmable Valves used for hydrocephalus may not operate properly | 05/16/2013Terminated |
| Z-0865-2013 Class II | NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMC61000000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0864-2013 Class II | NEUROPATH 6Fx100 GUIDING CATH HH Product Code: GHH61000000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0863-2013 Class II | NEUROPATH 6Fx90 GUIDING CATH S2 Product Code: GSM60900000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0862-2013 Class II | NEUROPATH 6Fx90 GUIDING CATH MCV Product Code: GCB60900000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0861-2013 Class II | NEUROPATH 5Fx90 GUIDING CATH HH Product Code: GHH50900000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0860-2013 Class II | NEUROPATH 6Fx90 GUIDING CATH ST Product Code: GST60900000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0859-2013 Class II | NEUROPATH 5Fx90 GUIDING CATH ST Product Code: GST50900000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0858-2013 Class II | NEUROPATH 5Fx100 GUIDING CATH ST Product Code: GST51000000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0857-2013 Class II | NEUROPATH 5Fx90 GUIDING CATH MPD Product Code: GMD50900000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0856-2013 Class II | NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMD61000000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0855-2013 Class II | NEUROPATH 5Fx90 GUIDING CATH MPC Product Code: GMC50900000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0854-2013 Class II | NEUROPATH 5Fx90 GUIDING CATH MCV Product Code: GCB50900000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0853-2013 Class II | NEUROPATH 5Fx100 GUIDING CATH MC Product Code: GCB51000000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0852-2013 Class II | NEUROPATH 6Fx100 GUIDING CATH S2 Product Code: GSM61000000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0851-2013 Class II | NEUROPATH 6Fx100 GUIDING CATH MC Product Code: GCB61000000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0850-2013 Class II | NEUROPATH 5Fx100 GUIDING CATH S2 Product Code: GSM51000000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0849-2013 Class II | NEUROPATH 6Fx100 GUIDING CATH ST Product Code: GST61000000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0848-2013 Class II | NEUROPATH 5Fx100 GUIDING CATH MP Product Code:GMD51000000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0847-2013 Class II | NEUROPATH 6Fx100 GUIDING CATH MPD Product Code: GMD60900000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0846-2013 Class II | NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GMC51000000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0845-2013 Class II | NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GHH51000000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0844-2013 Class II | NEUROPATH 6Fx90 GUIDING CATH HH Product Code: GHH60900000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0843-2013 Class II | NEUROPATH 5Fx90 GUIDING CATH S2 Product Code: GSM50900000 Intended for use in the…Sterility of device may be compromised due to lack of package integrity | 01/11/2013Terminated |
| Z-0842-2013 Class II | NEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for use in the…Sterility of device may be compromised due to lack of packaging integrity | 01/11/2013Terminated |
| Z-1279-2012 | Codman ICP Skull Bolt Kit, Product Code: 82-6638. Single Use, disposable drill kit for…Codman ICP Skull Bolt wrench is out of specification and cannot be used to turn the screw on the drill | 02/09/2012Terminated |
| Z-0710-2012 | Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Plastic Subarachnoid Screw…Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial… | 10/25/2011Terminated |
| Z-0709-2012 | Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Plastic Subarachnoid Screw…Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial… | 10/25/2011Terminated |
| Z-0708-2012 | Codman Cranial Disposable Intracranial Pressure (ICP) Kit, Stainless Steel Subarachnoid…Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial… | 10/25/2011Terminated |
| Z-0707-2012 | Codman Cranial Access Kit - complete with Xylocaine Product Code: 82-6614 Product Usage:…Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial… | 10/25/2011Terminated |
| Z-0706-2012 | Codman Cranial Access Kit with Xylocaine Product Code: 82-6612 Product Usage: The Codman…Incorrect version of Instructions for Use (IFU) for the Xylocaine product that is supplied with the Cranial… | 10/25/2011Terminated |
| Z-2701-2011 | CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System 4.5mm x 28mm…Mislabeled: One of the stick on stickers on the sterile pouch inside of the product box indicates the stent… | 03/21/2011Terminated |
| Z-2033-2011 | Codman Plastic Disposable ICP Kit, Complete, Adult Product Code 80-1197 This is a single…Packaging defect may compromise sterility of device | 11/30/2010Terminated |
| Z-2032-2011 | Codman Cranial Hand Drill Product Code: 82-6607 This is a single use, disposable drill…Packaging defect may compromise sterility of device | 11/30/2010Terminated |
| Z-2031-2011 | Codman Plastic Disposable ICP Kit, Adult Product Code: 80-1196 This is a single use…Packaging defect may compromise sterility of device | 11/30/2010Terminated |
| Z-2030-2011 | Codman Metal Disposable ICP Kit Product Code: 80-1190 This is a single use, disposable…Packaging defect may compromise sterility of device | 11/30/2010Terminated |
| Z-2029-2011 | Ghajar Guide Ventriculostomy Kit Product Code: 80-1185 This is a single use, disposable…Packaging defect may compromise sterility of device | 11/30/2010Terminated |
| Z-2028-2011 | Codman Disposable Twist Drill Product code: 80-1200 This is a single use, disposable…Packaging defect may compromise sterility of device | 11/30/2010Terminated |
| Z-0095-2011 | Surgical Pattie, 1/4" x 1/4" Non--Sterile (Each Unit of sales is 100 cards) of patties…Surgical Pattie x-ray stripe (radio-opaque marker) may become detached | 07/16/2010Terminated |
| Z-0094-2011 | Codman 1/4 x 1/4" Surgical Patties (20 pouches of 10 patties per box) Product code:…Surgical Pattie x-ray stripe (radio-opaque marker) became detached | 07/16/2010Terminated |
| Z-0093-2011 | Codman 5/16" Round Surgical Patties (20 pouches of 10 patties per box) Product code:…Surgical Pattie x-ray stripe (radio-opaque marker) became detached | 07/16/2010Terminated |