Clip, Implantable

FDA product code FZP · Class II (moderate risk) · 21 CFR 878.4300 · General, Plastic Surgery

177510(k) clearances
0PMA approvals
35recalls
Implantimplanted device

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K254231Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating ClipsFZP · Traditional Taiwan Surgical Corporation07/20/2026SE
K253903InnoClip Disposable Clip ApplierFZP · Special Taiwan Surgical Corporation12/22/2025SE
K253781InnoClip Clip ApplierFZP · Special Taiwan Surgical Corporation12/22/2025SE
K250643Disposable Polymer Ligation ClipsFZP · Traditional Hangzhou Kangji Medical Instrument Co., Ltd.11/20/2025SE
K251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsFZP · Traditional Teleflex Medical07/03/2025SE
K242541Gem ZipclipFZP · Traditional Synovis Micro Companies Alliance A Subsidiary of…01/15/2025SE
K221495SOLID CLIP™ Single Use Clip ApplierFZP · Traditional Medscope Biotech Co., Ltd.07/18/2024SE
K232970Hem-o-lok® Ligating ClipsFZP · Traditional Teleflex Medical01/12/2024SE
K230966angiOCCLUDE Ligating ClipsFZP · Traditional A2 Medical Systems, LLC09/19/2023SE
K232313LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic…FZP · Special Ethicon Endo Surgery, LLC08/29/2023SE
K230480Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)FZP · Special Teleflex Medical04/28/2023SE
K213813DuraFuse Clip and Applier SystemFZP · Traditional Neuramedica, Inc.07/22/2022SE
K220006angioLOCK Polymer Ligating ClipFZP · Traditional A2 Medical Systems, LLC03/02/2022SE
K202994InnoClip Disposable Clip Applier, InnoClip Clip ApplierFZP · Traditional Taiwan Surgical Corporation01/04/2022SE
K200166Mirus Ligating Clip, Mirus Ligating Clip ApplierFZP · Traditional M/s. Meril Endo Surgery Private Limited.11/23/2020SE
K202124Aesculap PAS-Port Proximal Anastomosis SystemFZP · Special Aesculap, Inc.09/02/2020SE
K192711Dannik Titanium Ligation ClipFZP · Traditional Dannik12/20/2019SE
K180650Amsel Endo OccluderFZP · Traditional Amsel Medical Corporation11/15/2018SE
K181488LIGACLIP 12mm L Endoscopic Rotating Multiple Clip ApplierFZP · Traditional Ethicon Endo-Surgery, LLC10/30/2018SE
K173323AnastoClip GC Closure SystemFZP · Traditional LeMaitre Vascular, Inc.03/08/2018SE
K180010AtriClip FLEX-VFZP · Special AtriCure, Inc.01/31/2018SE
K173031AtriClip LAA Exclusion System with Preloaded PRO·V ClipFZP · Special AtriCure, Inc.10/25/2017SE
K172742AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)FZP · Special AtriCure, Inc.10/11/2017SE
K172479Amsel Occluder DeviceFZP · Special Amsel Medical09/14/2017SE
K163261AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded…FZP · Traditional AtriCure, Inc.05/19/2017SE
K161758Weck Auto Endo10 Automatic Endoscopic Clip ApplierFZP · Traditional Teleflex Medical09/07/2016SE
K151943Vas-Q-ClipFZP · Traditional Nanova Biomaterials, Inc.03/25/2016SE
K160454AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipFZP · Special AtriCure, Inc.03/18/2016SE
K152082Vesocclude Polymer Ligating ClipFZP · Traditional Vesocclude Medical, LLC02/26/2016SE
K153500AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V ClipFZP · Traditional AtriCure, Inc.01/27/2016SE
K150259CLIP PLUS Disposable Clip Applier,ML;CLIP PLUS Disposable Clip Applier,LFZP · Traditional Taiwan Surgical Corporation11/06/2015SE
K150936SureClipFZP · Traditional Conmed Corporation10/23/2015SE
K143644Premium Surgiclip¿; Endo Clip¿; AcuClip¿FZP · Traditional Covidien09/14/2015SE
K150840Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip ApplierFZP · Traditional Ethicon Endo-Surgery, LLC09/10/2015SE
K152081Weck Auto Endo5 Hem-o-lok Ligating Clip ApplierFZP · Special Teleflexmedical, Inc.08/26/2015SE
K150996AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipFZP · Special AtriCure, Inc.06/17/2015SE
K143598Lapro-Clip Auto Suture Reusable Long Clip ApplierFZP · Special Covidien, LLC03/12/2015SE
K140932Amsel Occluder DeviceFZP · Traditional Amsel Medical Corporation01/23/2015SE
K142777Weck Hem-o-lok Auto Endo5 Ligating Clip ApplierFZP · Traditional Teleflexmedical, Inc.12/19/2014SE
K142869Premium Surgiclip IIIFZP · Special Covidien10/30/2014SE
K142120Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipFZP · Special AtriCure, Inc.08/28/2014SE
K133202Hem-O-Lok Ligating ClipFZP · Traditional Teleflex Medical12/03/2013SE
K132658Hemoclip Traditional Ligating Clips, Hemoclip Plus Ligating Clips, Horizon Ligting ClipsFZP · Traditional Teleflex Medical11/27/2013SE
K131107Atriclip Gillinov-Cosgrove Laa ClipFZP · Special AtriCure, Inc.05/14/2013SE
K122276Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipFZP · Special AtriCure, Inc.08/29/2012SE
K121194Endo Clip III 5MM Clip ApplierFZP · Special Covidien05/03/2012SE
K111930Ackermann EuropclipFZP · Traditional Ackermann Instrumente GmbH11/08/2011SE
K110699Ligamax 5FZP · Traditional Ethicon Endo-Sugery, LLC03/25/2011SE
K093661ColonringFZP · Traditional Niti Surgical Solutions, Ltd.02/10/2011SE
K102081Endoscopic Clip SystemFZP · Special Aesculap, Inc.08/06/2010SE
K101018Cardica C-Port Xa Plus Distal Anastomosis System, Model FG-000100FZP · Special Cardica, Inc.06/25/2010SE
K093679Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove…FZP · Traditional AtriCure, Inc.06/10/2010SE
K091987Anastoclip Models 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, AnastoclipFZP · Traditional LeMaitre Vascular, Inc.04/23/2010SE
K100242Auto Suture Endo Clip III5MM Clip AdapterFZP · Special Surgical Devices, A Division of Tyco Healthcare02/17/2010SE
K100090Implantable ClipFZP · Special Genicon02/02/2010SE
K091060Vesocclude Ligating ClipFZP · Traditional Vesocclude Medical, LLC09/23/2009SE
K091017Cardica Pas-Port Proximal Anastomosis System, Model FG-000001FZP · Special Cardica, Inc.04/29/2009SE
K090872Modification to Cardica C-Port Xa Distal Anastomosis SystemFZP · Special Cardica, Inc.04/21/2009SE
K081225Cardica Pas-Port Proximal Anastomosis SystemFZP · Traditional Cardica, Inc.09/05/2008SE
K081082U-Clip Uni-Fire, Model M65FZP · Traditional Medtronic, Inc.05/07/2008SE
K081031Endoscopic Clip Appliers with Clip MagazineFZP · Special Aesculap, Inc.05/05/2008SE
K080753Aesculap Endoscopic Clip SytemFZP · Special Aesculap, Inc.04/02/2008SE
K073304Cardica C-Port X-Change Anastomosis System and Handle and Xa X-Change SubassembliesFZP · Special Cardica, Inc.12/20/2007SE
K073123Cardica C-Port Flex-A Distal Anastomosis System, Model FG-000150FZP · Special Cardica, Inc.12/06/2007SE
K071406Autosuture Endo Clip III 5 MM Clip ApplierFZP · Traditional United States Surgical, A Division of Tyco Healthc11/21/2007SE
K072525Zipknot, Model 1017-3000FZP · Special Medicinelodge, Inc.10/05/2007SE
K070548C-Port Flexa Distal Anastomosis SystemFZP · Special Cardica, Inc.03/29/2007SE
K063644Cardica C-Port Xa Distal Anastomosis SystemFZP · Special Cardica, Inc.01/11/2007SE
K062821U-Clip DeviceFZP · Traditional Medtronic Neurosurgery12/19/2006SE
K053524C-Port Distal Anastomosis SystemFZP · Traditional Cardica, Inc.11/16/2006SE
K062914Hem-O-Lok Ligation ClipFZP · Traditional Teleflex Medical11/02/2006SE
K061288Auto Suture Endo Clip III 5 MM Clip ApplierFZP · Special United States Surgical, A Division of Tyco Healthc11/02/2006SE
K062008Endo Car Compression Anastomosis Ring (Car)FZP · Special Niti Medical Technologies , Ltd.08/09/2006SE
K062057U-Clip Device, Model NC65FZP · Special Medtronic Vascular08/02/2006SE
K053255Nexus Ligating ClipFZP · Traditional Microsurgical Laboratories,Inc.Dba Wexler Surgical03/14/2006SE
K053252U-Clip Device, Models B140, B160 and B180FZP · Special Medtronic Vascular12/16/2005SE
K040832C-Port Anastomosis System (Deployment System, Clip, Accessories), Model FG-000050FZP · Traditional Cardica, Inc.11/10/2005SE
K052018Miltex Ligating ClipFZP · Traditional Miltex, Inc.11/04/2005SE
K051125Ivs Clip Closure System, Model 1002 (Ivs Clip Applier), 14677FZP · Special Abbott Laboratories06/08/2005SE
K050356Compression Anastomosis Ring (Car)FZP · Traditional Niti Medical Technologies , Ltd.05/05/2005SE
K050344Ligaclip 5 M/L MM Endoscopic Multiple Clip ApplierFZP · Traditional Ethicon Endo Surgery, Inc.03/14/2005SE
K043115Laparoscopic Compression Anastomosis Clip (Lapcac)FZP · Traditional Niti Medical Technologies , Ltd.12/01/2004SE
K041751Compression Anastomosis Clip (Cac)FZP · Traditional Niti Medical Technologies , Ltd.09/16/2004SE
K040602Sureline Laparoscopic Clip Applier with Implantable Titanium ClipsFZP · Traditional Design Standards Corp.05/10/2004SE
K033324Compression Anastomosis Clip (Cac)FZP · Traditional Niti Medical Technologies , Ltd.05/10/2004SE
K040821Coalescent Surgical U-Clip and AccessoriesFZP · Traditional Coalescent Surgical04/23/2004SE
K033979Corlink Automated Anastomotic SystemFZP · Traditional By-Pass Makafim , Ltd.03/31/2004SE
K032896Anson Refix Vascular and Tissue Clip, Models GF-04-01 and GF-04-02FZP · Traditional Anson Medical , Ltd.03/17/2004SE
K033161Visu-Lock 5MM Clip ApplierFZP · Traditional Gyrx, LLC12/18/2003SE
K032980Ami Reprocessed Multiple Clip AppliersFZP · Traditional Vanguard Medical Concepts, Inc.12/18/2003SE
K033024Modification to Suture ClinchFZP · Special Applied Medical Resources Corp.10/24/2003SE
K032238Twister Superelastic Ligating Clip and ApplierFZP · Traditional Neurosel (Medical) Limited09/09/2003SE
K03221714G Cormark Biopsy Site IdentifierFZP · Special Artemis Medical, Inc.08/21/2003SE
K030926Fast Throw Stainless Steel Surgical SutureFZP · Traditional Advanced Surgical Products, Inc.07/21/2003SE
K031623Modification to Coalescent Surgical U-Clip and AccessoriesFZP · Special Coalescent Surgical07/03/2003SE
K030269Genicon Clip ApplierFZP · Traditional Genicon, LC03/20/2003SE
K030311Hem-O-Lok XL ClipFZP · Special Weck02/26/2003SE
K024366Coalescent Surgical U-Clip and AccessoriesFZP · Special Coalescent Surgical01/17/2003SE
K020054Sanarus Indica Marker SystemFZP · Traditional Sanarus Medical, Inc.10/16/2002SE
K020879Ivs Clip Closure System, Model 1002 (Ivs Clip Applier); Ivs Intruducer Set, Model 1001FZP · Traditional Integrated Vascular Systems, Inc.09/25/2002SE
K021808Weck Hem-O-Lok Automatic Ligating Clip ApplierFZP · Traditional Weck08/14/2002SE
K021407Coalescent Surgical U-Clip - or Other TBD and AccessoriesFZP · Traditional Coalescent Surgical07/03/2002SE
K020470Modification to Corlink Automated Anastomotic DeviceFZP · Special Bypass , Ltd.03/08/2002SE
K013264Micro Stamping Ligating ClipFZP · Traditional Micro Stamping Corp.11/29/2001SE
K012342Ams Soft-Tissue Approximation SystemFZP · Traditional American Medical Systems, Inc.09/05/2001SE
K012317Coalescent Surgical U-ClipFZP · Traditional Coalescent Surgical08/31/2001SE
K011402Biopsy Site MarkerFZP · Traditional Senorx, Inc.07/16/2001SE
K011236Modification to Implantable ClipFZP · Special Applied Medical Resources Corp.05/14/2001SE
K003777Caris Site MarkerFZP · Traditional Artemis Medical, Inc.03/06/2001SE
K003958Coalescent U-Clip Delivery and Disposal DeviceFZP · Traditional Coalescent Surgical02/06/2001SE
K003337Hem-O-Lok SMX, Model 544220; Hem-O-Lok ML, Model 544230; Hem-O-Lok MLX, Model 544240FZP · Traditional Weck Closure Systems12/21/2000SE
K001450Auto Suture Micro Surgiclip Clip ApplierFZP · Traditional United States Surgical, A Division of Tyco Healthc07/18/2000SE
K000278Vivant Medical Biopsy Marker SystemFZP · Traditional Vivant Medical, Inc.06/23/2000SE
K994160Coalescent Surgical Sutured-ClipFZP · Traditional Coalescent Surgical02/04/2000SE
K993424The True Y Clip, the Micro Y Clip, the Laparoscopic Y ClipFZP · Traditional Y-Clip Associates12/23/1999SE
K993157Hem-O-Lok SMX Polymer Clips, Model 544220, HEM-0-LOK MLX Polymer Clips, Model 544240FZP · Traditional Weck Closure Systems12/17/1999SE
K993135Implantable Clip for General SurgeryFZP · Traditional Applied Medical Resources12/01/1999SE
K991002Psi Titanium Micro-Ligation Hemostatic ClipFZP · Traditional V. Mueller Neuro/Spine06/11/1999SE
K984438Modified Auto Suture*Vcs** Anastomotic**Clip CartridgeFZP · Traditional United States Surgical, A Division of Tyco Healthc01/07/1999SE
K982944Hem-O-Lock, Model 523935FZP · Traditional Weck Closure Systems11/19/1998SE
K982941Hem-O-Lok Model Numbers 523900, 523970FZP · Traditional Weck Closure Systems11/19/1998SE
K981645Titanium Hemostatic ClipFZP · Traditional Vitalitec Int'L., Inc.10/13/1998SE
K982313Horizon Titanium Clips, Horizon Tantalum ClipsFZP · Traditional Weck Closure Systems08/10/1998SE
K981631Influence Clip SystemFZP · Traditional Influence, Inc.07/28/1998SE
K981239Deroyal Industries Disposable Laparoscopic Clip Applier with Implantable Titanium ClipsFZP · Traditional Deroyal Surgical05/14/1998SE
K973652Duoclipper Titanium ClipsFZP · Traditional Scion International, Inc.03/27/1998SE
K971588Evi Sutured-Clip ApplierFZP · Traditional Elective Vascular Intervention Inc. (Evi)10/24/1997SE
K970793Implantable ClipFZP · Traditional United States Surgical, A Division of Tyco Healthc07/30/1997SE
K971201Auto Suture* Ilm** KitFZP · Traditional United States Surgical, A Division of Tyco Healthc06/03/1997SE
K964470Applied Medical Clip ApplierFZP · Traditional Applied Medical Resources01/22/1997SE
K964109Microsurge Laparoscopic Permaclip Cartridge with Implantable ClipFZP · Traditional Microsurge, Inc.11/27/1996SE
K962043Auto Suture Modified VCS Clip ApplierFZP · Traditional United States Surgical, A Division of Tyco Healthc09/23/1996SE
K962016Medline Titanium HemoclipsFZP · Traditional Medline Industries, Inc.07/24/1996SE
K953258Titanium Hemostatic ClipFZP · Traditional Intramed Laboratories, Inc.01/05/1996SE
K953908Davis & Geck Ligating Clip RemoverFZP · Traditional Davis & Geck, Inc.11/30/1995SE
K954435Wilomat Sterilizable Clip Forceps W/Interchangable MagazinesFZP · Traditional Wilo Medizintechnik Lothar Wilberg GmbH10/23/1995SE
K950540Implantable ClipFZP · Traditional United States Surgical, A Division of Tyco Healthc04/13/1995SE
K945231Self-Latching ClipFZP · Traditional Surgical System, Inc.01/27/1995SE
K944552Pilling Weck M-20 Disposable Automatic HemoclipFZP · Traditional Pilling Weck, Inc.11/07/1994SE
K943159Life Clip and Life Clip ApplierFZP · Traditional Life Surgery, Inc.08/16/1994SE
K941972Hemo-O-LokFZP · Traditional King & Spalding06/29/1994SE
K934087Implantable Clip ApplierFZP · Traditional United States Surgical, A Division of Tyco Healthc12/01/1993SE
K933887Implantable ClipFZP · Traditional United States Surgical, A Division of Tyco Healthc11/24/1993SE
K931492Lapra-Ty* Suture ClipFZP · Traditional ETHICON, Inc.08/24/1993SE
K920847Ethicon Ligaclip Endo LD Applier/DividerFZP · Traditional ETHICON, Inc.05/29/1992SE
K915151Auto Suture Modified Polymer Skin Graft StapleFZP · Traditional United States Surgical, A Division of Tyco Healthc01/13/1992SE
K911915Hemoclip IIFZP · Traditional Edward Weck, Inc.01/09/1992SE
K905587Auto Suture(R) Endoscopic Lds(Tm) Ligating DeviceFZP · Traditional United States Surgical, A Division of Tyco Healthc01/16/1991SE
K902108Hem-O-Lok(Tm)FZP · Traditional Edward Weck, Inc.08/06/1990SE
K900122Auto Suture Latchless Absorbable Hemostatic Clip*FZP · Traditional United States Surgical, A Division of Tyco Healthc03/20/1990SE
K896997Atrauclip (Titanium Hemostatic Clip)FZP · Traditional S.P.K. Technology, Inc.02/13/1990SE
K883018Auto Suture Disp. Endoscopic Surg. Clip ApplierFZP · Traditional United States Surgical, A Division of Tyco Healthc08/03/1988SE
K873309Reflex(Tm) Ca-T Clip ApplierFZP · Traditional Richard-Allan Medical Ind., Inc.11/27/1987SE
K864350Vicryl* Polyglactin 730 Absorbable Staples/StaplerFZP · Traditional ETHICON, Inc.12/18/1986SE
K864102Ligaclip 20/20* Multiple Clip ApplierFZP · Traditional ETHICON, Inc.11/05/1986SE
K862404Reflex(Tm) Clip ApplierFZP · Traditional Richard-Allan Medical Ind., Inc.07/23/1986SE
K861922Titanium Hemostatic ClipsFZP · Traditional Pilling Co.06/13/1986SE
K861471V. Mueller Vital Clip-Hemostatic ClipFZP · Traditional American V. Mueller06/06/1986SE
K853650Auto Suture Titanium Hemostatic ClipFZP · Traditional United States Surgical, A Division of Tyco Healthc09/19/1985SE
K851251Auto/Manual Titanium Hemoclip Ligating Clip 527200FZP · Traditional Edward Weck, Inc.07/02/1985SE
K850273Ethicon - CholangioclipFZP · Traditional ETHICON, Inc.04/17/1985SE
K843336Automatic Multiclip Dispos. LigatingFZP · Traditional Davis & Geck, Inc.10/31/1984SE
K843589Ticlip Sterial DisposableFZP · Traditional Western Medical Products, Inc.10/24/1984SE
K841549Hemoclip Automatic Clips MediumFZP · Traditional Edward Weck, Inc.08/14/1984SE
K841548Hemoclip Ligating Clips M/LargeFZP · Traditional Edward Weck, Inc.08/14/1984SE
K841547Hemoclip Ligating Clips Med/SmlFZP · Traditional Edward Weck, Inc.08/14/1984SE
K8423823M Rapidstat Ligating Clip SysFZP · Traditional 3M Company08/10/1984SE
K834267Ligaclip Metallic Ligating ClipFZP · Traditional ETHICON, Inc.03/12/1984SE
K831457Auto Suture Poly Surgiclip HemostaticFZP · Traditional United States Surgical, A Division of Tyco Healthc08/08/1983SE
K830503Ligaclip Titanium Ligating ClipFZP · Traditional ETHICON, Inc.03/08/1983SE
K820999Multiclip Disp. Ligating Clip DeviceFZP · Traditional Davis & Geck, Inc.05/13/1982SE
K812323Pds* Absorbable Ligating ClipsFZP · Traditional ETHICON, Inc.11/16/1981SE
K811935Prolene Polypropylene Ligating ClipFZP · Traditional ETHICON, Inc.09/11/1981SE
K801124Nylon Ligating ClipFZP · Traditional ETHICON, Inc.06/17/1980SE
K800079Hemoclip Surgical Occluding ClipFZP · Traditional Edward Weck, Inc.01/28/1980SE
K771413Ligaclip Multiple Ligating ClipsFZP · Traditional ETHICON, Inc.11/28/1977SE
K771112Auto Suture R ClipFZP · Traditional United States Surgical, A Division of Tyco Healthc09/30/1977SE

Recalls

RecallProductFirmInitiated
Z-1663-2023 Class IITeleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in…Teleflex LLC is initiating this voluntary field corrective action because the clip cartridges for the… Teleflex LLC04/28/2023Open, Classified
Z-2579-2021 Class IIPAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical… Aesculap Implant Systems LLC04/16/2021Terminated
Z-2578-2021 Class IIPAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SUMalfuncton-Implant did not deploy successfully may necessitate the need for an additional medical… Aesculap Implant Systems LLC04/16/2021Terminated
Z-0310-2021 Class IIA Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm - Product Usage: intended…Device malfunction causing the applier to jam, and clip loading failures. Genicon, Inc.09/17/2020Open, Classified
Z-0656-2020 Class IILigamax 5 mm Endoscopic Multiple Clip ApplierA potential exists that certain LIGAMAX devices within the impacted lots may have small holes in the Tyvek… Ethicon Endo-Surgery Inc11/07/2019Terminated
Z-0497-2020 Class IIWECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543965…Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a… Teleflex Medical10/04/2019Open, Classified
Z-0496-2020 Class IIWECK AutoEndo5, Automatic Hem-O-Lok Clip Applier, REF AE05ML Automatic Endoscopic…Certain clip appliers have an increase in misloading and/or jamming related complaints that may be due to a… Teleflex Medical10/04/2019Open, Classified
Z-2434-2018 Class IIAesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis System, Catalog Number:…Following pressurization of the devices, damage to the device handle mechanism may occur, accompanied by a… Aesdex04/02/2018Terminated
Z-2433-2018 Class IIAesDex, LLC Cardica C-Port xA PLUS Anastomosis System. Catalog Number FG-000100. The…Following pressurization of the devices, damage to the device handle mechanism may occur, accompanied by a… Aesdex04/02/2018Terminated
Z-1291-2018 Class IIDS Titanium Ligation Clip Appliers, used in laparoscopic surgeryAdded a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other… Aesculap Implant Systems LLC01/22/2018Terminated
Z-1290-2018 Class IIDS Titanium Ligation Clip, used in laparoscopic surgeryAdded a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other… Aesculap Implant Systems LLC01/22/2018Terminated
Z-0083-2018 Class IIWECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML…The product has a non-conformity that may cause clips to mislead, jam or fall out of the applier. Teleflex Medical10/05/2017Terminated
Z-1148-2017 Class IIAtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single PRO2…A complaint of the PRO2 jaw breaking prior to surgery being performed. AtriCure, Inc.11/30/2016Terminated
Z-0377-2017 Class IIAtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for…There is a potential for a component failure of the device which could necessitate medical intervention. AtriCure, Inc.09/22/2016Terminated
Z-2289-2016 Class IIAnastoCiip Universal Clip Remover (1Each} REF# e4001-04 The Anastoclip Clip applier…US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be… LeMaitre Vascular, Inc.06/22/2016Terminated
Z-2288-2016 Class IIAnastoCiip Universal Clip Remover (6 Pack} REF# e4001-00 The Anastoclip Clip applier…US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be… LeMaitre Vascular, Inc.06/22/2016Terminated
Z-2287-2016 Class IIAnastoCiip Universal Clip Remover (1Each} REF# 4001-04 The Anastoclip Clip applier…US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be… LeMaitre Vascular, Inc.06/22/2016Terminated
Z-2286-2016 Class IIAnastoCiip Universal Clip Remover (6 Pack} REF# 4001-00 The Anastoclip Clip applier…US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be… LeMaitre Vascular, Inc.06/22/2016Terminated
Z-2285-2016 Class IIAnasto AC Closure System and Anasto Universal Clip Remover- Anasto AC 8cm 25 Clips (1…US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be… LeMaitre Vascular, Inc.06/22/2016Terminated
Z-2284-2016 Class IIAnastoClip AC 8cm 35 Clips (1 Each} Large REF # 4000-07 The Anastoclip Clip applier…US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be… LeMaitre Vascular, Inc.06/22/2016Terminated
Z-2283-2016 Class IIAnastoclip AC 8cm 35 Clips (1 Each} Medium REF # 4000-06 The Anastoclip Clip applier…US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be… LeMaitre Vascular, Inc.06/22/2016Terminated
Z-1621-2016 Class IIDirect Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels…Increased customer complaints indicating inconsistent clip application; may lead to unoccluded vessels. Applied Medical Resources Corp04/01/2016Terminated
Z-0886-2016 Class IIAuto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx Only…The clip in the applier may be missing a boss. A boss is the part of the clip that is used to hold the clip… Teleflex Medical02/02/2016Terminated
Z-0826-2015 Class IIWECK Hemoclip Traditional Medium Tantalum Ligating Clips. Weck Ligating Clips are…The manufacturing dates and expiration dates were transposed on the Tyvek label. Teleflex Medical12/03/2014Terminated
Z-2327-2016 Class IIHorizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, Sterile. The…The manufacturing and expiration dates are not printed on the blister pack label. Teleflex Medical08/08/2013Terminated
Z-1524-2013 Class IIBARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. Intended for use to…Bard Peripheral Vascular (BPV) has confirmed that some devices with the recalled product code / lot number… Bard Peripheral Vascular Inc04/16/2013Terminated
Z-0078-2013 Class IIHem-o-lok Large Polymer Ligating Clips, REF #544240, Rx only, Sterile, Teleflex Medical…Product is being recalled due to the possibility that the tray may contain pinholes, compromising product… Teleflex Medical09/25/2012Terminated
Z-2030-2010 Medtronic U-CLIP Double Arm Approximation Device, model V100D U-Clip, Catalog Number…Medtronic received reports involving the V100D U-Clip where during handling, the release mechanism has… Medtronic Cardiovascular Revascularization…04/02/2010Terminated
Z-0160-2009 WECK HemoClip Auto, Rx Only, Sterile, Teleflex Medical, RTC, NC 27709. The use of the…A hole in the sterile unit blister pack was detected that would compromise sterility. Telefelx Medical08/22/2008Terminated
Z-0159-2009 WECK Hem-o-lok Non-absorbable Polymer Ligation Clips, Rx Only, Sterile, Teleflex…A hole in the sterile unit blister pack was detected that would compromise sterility. Telefelx Medical08/22/2008Terminated
Z-0158-2009 Weck , Horizon Titanium Clips, Rx Only, Sterile, Teleflex Medical, RTP, NC 27709, USA.…A hole in the sterile unit blister pack was detected that would compromise sterility. Telefelx Medical08/22/2008Terminated
Z-0157-2009 Weck Hemoclip Plus Ligating Clips, Rx Only, Sterile, Teleflex Medical, RTP, NC 27709…A hole in the sterile unit blister pack was detected that would compromise sterility. Telefelx Medical08/22/2008Terminated
Z-0156-2009 Weck Hemoclip Traditional Ligating Clips, Rx Only, Sterile, Teleflex Medical, RTP, NC…A hole in the sterile unit blister pack was detected that would compromise sterility. Telefelx Medical08/22/2008Terminated
Z-1609-2008 VNUS Medical U-CLIP Removal Tool, UREM1860, is intended for the removal of U-Clip…Medtronic has identified one lot #0610315 of U-Clip Removal Tools, Catalog UREM1860FW, that was incorrectly… Medtronic Cardiac Surgery Technologies02/25/2008Terminated
Z-0968-2007 Medtronic U-CLIP Anastomotic Device Removal Tool, model REM1860FW. The U-Clip…Six lots of U-Clip Removal Tools, catalog REM1860FW were incorrectly assembled. The nose cone attachment to… Medtronic Cardiac Surgery Technologies02/08/2007Terminated