Catheter, Recording, Electrode, Reprocessed
FDA product code NLH · Class II (moderate risk) · 21 CFR 870.1220 · Cardiovascular
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
70510(k) clearances
0PMA approvals
48recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252405 | Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable…NLH · Traditional | Surgical Instrument Service and Savings, Inc. | 11/26/2025SE |
| K250772 | Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable…NLH · Traditional | Surgical Instrument Service and Savings, Inc. | 07/11/2025SE |
| K242225 | Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic CatheterNLH · Traditional | Surgical Instrument Service and Savings, Inc. | 11/29/2024SE |
| K241224 | Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer…NLH · Traditional | Surgical Instrument Service and Savings Inc.(Dba… | 11/15/2024SE |
| K240826 | Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar…NLH · Traditional | Sterilmed, Inc. | 10/11/2024SE |
| K241156 | Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter…NLH · Traditional | Surgical Instrument Service and Savings, Inc. | 09/14/2024SE |
| K240972 | Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)NLH · Traditional | Surgical Instrument Service and Savings, Inc. | 06/07/2024SE |
| K233825 | Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterNLH · Traditional | Innovative Health | 06/07/2024SE |
| K221067 | Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology CatheterNLH · Traditional | Surgical Instrument Service and Savings, Inc. | 05/31/2023SE |
| K221854 | Reprocesses Umbilical CableNLH · Traditional | Innovative Health, LLC | 08/06/2022SE |
| K211276 | Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology CathetersNLH · Traditional | Innovative Health, LLC | 09/15/2021SE |
| K203655 | Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS…NLH · Traditional | Innovative Health, LLC | 05/04/2021SE |
| K200205 | Reprocessed Advisor FL Circular Mapping Catheter, Sensor EnabledNLH · Traditional | Stryker Sustainability Solutions | 05/13/2020SE |
| K193263 | Reprocessed Achieve Catheter Connecting CableNLH · Traditional | Innovative Health, LLC | 01/24/2020SE |
| K191170 | Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology CatheterNLH · Traditional | Innovative Health, LLC | 10/30/2019SE |
| K190127 | Reprocessed Livewire Steerable Diagnostic Electrophysiology CatheterNLH · Traditional | Innovative Health, LLC | 08/23/2019SE |
| K182488 | Reprocessed Response Diagnostic Electrophysiology CatheterNLH · Traditional | Innovative Health, LLC | 02/22/2019SE |
| K181056 | Reprocessed CS Diagnostic Electrophysiology CatheterNLH · Traditional | Stryker Sustainability Solutions | 01/24/2019SE |
| K181897 | Reprocessed Marinr Diagnostic EP CatheterNLH · Traditional | Innovative Health, LLC | 11/15/2018SE |
| K181458 | Reprocessed Advisor FL Sensor Enabled Circular Mapping CatheterNLH · Traditional | Innovative Health, LLC | 10/27/2018SE |
| K181618 | Reprocessed Torqr Diagnostic EP CatheterNLH · Traditional | Innovative Health, LLC | 10/18/2018SE |
| K180710 | Reprocessed DecaNav Diagnostic Electrophysiology CatheterNLH · Traditional | Innovative Health, LLC | 06/19/2018SE |
| K171788 | Reprocessed Halo XP Diagnostic Electrophysiology CatheterNLH · Traditional | Innovative Health, LLC | 11/03/2017SE |
| K171503 | Reprocessed CristaCath Diagnostic Electrophysiology CatheterNLH · Traditional | Innovative Health, LLC | 10/05/2017SE |
| K170922 | Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS…NLH · Traditional | Innovative Health, LLC | 06/22/2017SE |
| K161272 | Supreme and Response Electrophysiology CathetersNLH · Traditional | Surgical Instrument Service and Savings, Inc. | 05/18/2017SE |
| K162251 | Reprocessed Viking Diagnostic Electrophysiology CathetersNLH · Traditional | Innovative Health, LLC | 12/21/2016SE |
| K161827 | Reprocessed Response Diagnostic Electrophysiology CathetersNLH · Traditional | Innovative Health, LLC | 12/08/2016SE |
| K160421 | Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry…NLH · Traditional | Innovative Health, LLC | 11/02/2016SE |
| K161393 | Reprocessed Orbiter ST Steerable Diagnostic EP CatheterNLH · Traditional | Innovative Health, LLC | 10/26/2016SE |
| K161464 | Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology CathetersNLH · Traditional | Innovative Health, LLC | 09/30/2016SE |
| K153006 | Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) CatheterNLH · Traditional | Sterilmed, Inc. | 06/23/2016SE |
| K160496 | Reprocessed Inquiry Steerable Diagnostic EP CatheterNLH · Traditional | Innovative Health, LLC | 06/10/2016SE |
| K160303 | Reprocessed Polaris X Steerable Diagnostic EP CatheterNLH · Traditional | Innovative Health, LLC | 05/10/2016SE |
| K160242 | Reprocessed Livewire Steerable Diagnostic EP CatheterNLH · Traditional | Innovative Health, LLC | 05/10/2016SE |
| K153153 | Reprocessed Electrophysiology CatheterNLH · Traditional | Innovative Health, LLC | 03/14/2016SE |
| K151617 | Livewire Electrophysiology CatheterNLH · Traditional | Surgical Instrument Service and Savings Inc.(Dba… | 01/22/2016SE |
| K150357 | Reprocessed Electrophysiology Diagnostic CathetersNLH · Traditional | Sterilmed, Inc. | 08/27/2015SE |
| K121158 | Reprocessed Electrophysiology Diagnostic CathetersNLH · Traditional | Sterilmed, Inc. | 08/06/2012SE |
| K112292 | Reprocessed 2515 Nav Variable Electrophysiology CatheterNLH · Traditional | Stryker Sustainability Solutions | 10/21/2011SE |
| K112232 | Reprocessed Electrophysiology CathetersNLH · Traditional | Stryker Sustainability Solutions | 09/26/2011SE |
| K101789 | Reprocessed Electrophysiology Diagnostic CathetersNLH · Traditional | Sterilmed, Inc. | 08/19/2010SE |
| K100254 | Reprocessed CS Bi-Diectional Diagnostic Electrophysiology CatheterNLH · Traditional | Ascent Healthcare Solutions | 05/28/2010SE |
| K092158 | Reprocessed Electrophysiology Diagnostic CathetersNLH · Traditional | Sterilmed, Inc. | 01/14/2010SE |
| K090323 | Reprocessed Electrophysiology CathetersNLH · Traditional | Ascent Healthcare Solutions | 04/01/2009SE |
| K082023 | Reprocessed Electrophysiology CathetersNLH · Traditional | Ascent Healthcare Solutions | 09/16/2008SE |
| K081329 | Reprocessed Electrophysiology CathetersNLH · Traditional | Ascent Healthcare Solutions | 07/09/2008SE |
| K061045 | Reprocessed Electrophysiology CathetersNLH · Traditional | Alliance Medical Corp. | 08/31/2006SE |
| K052603 | Reprocessed Daig Livewire Electrophysiology CathetersNLH · Traditional | Alliance Medical Corp. | 11/16/2005SE |
| K052414 | Reprocessed Electrophysiology CatheterNLH · Traditional | Alliance Medical Corp. | 11/16/2005SE |
| K051220 | Reprocessed Deflectable Electrophysiology Diagnostic CathetersNLH · Traditional | Sterilmed, Inc. | 06/14/2005SE |
| K051043 | Vanguard Reprocessed Diagnostic Electrophysiology CathetersNLH · Traditional | Vanguard Medical Concepts, Inc. | 06/06/2005SE |
| K050763 | Vanguard Reprocessed Diagnostic Electrophysiology CathetersNLH · Traditional | Vanguard Medical Concepts, Inc. | 06/01/2005SE |
| K043392 | Reprocessed Electrophysiology CathetersNLH · Traditional | Alliance Medical Corp. | 03/25/2005SE |
| K043393 | Reprocessed Ep Technologies Electrophysiology CathetersNLH · Traditional | Alliance Medical Corp. | 03/23/2005SE |
| K040751 | Vanguard Reprocessed Diagnostic Electrophysiology CathetersNLH · Traditional | Vanguard Medical Concepts, Inc. | 03/10/2005SE |
| K042074 | Vanguard Reprocessed Diagnostic Electrophysiology CathetersNLH · Traditional | Vanguard Medical Concepts, Inc. | 03/09/2005SE |
| K043513 | Sterilmed Reprocessed Deflectable Electrophysiology Diagnostic CatheterNLH · Traditional | Sterilmed, Inc. | 03/01/2005SE |
| K030279 | Reprocessed Electrophysiology CatheterNLH · Traditional | Alliance Medical Corp. | 10/03/2003SE |
| K030187 | Reprocessed Electrophysiology CatheterNLH · Traditional | Alliance Medical, Inc. | 09/24/2003SE |
| K030109 | Electrophysiology CatheterNLH · Traditional | Alliance Medical Corp. | 08/08/2003SE |
| K030026 | Reprocessed Electrophysiology CatheterNLH · Traditional | Alliance Medical Corp. | 05/02/2003SE |
| K030114 | Vanguard Reprocessed Diagnostic Electrophysiology CathetersNLH · Traditional | Vanguard Medical Concepts, Inc. | 03/21/2003SE |
| K023180 | Vanguard Reprocessed Diagnostic Electrophysiology CathetersNLH · Traditional | Vanguard Medical Concepts, Inc. | 12/12/2002SE |
| K022316 | Vanguard Reprocessed Diagnostic Electrophysiology CathetersNLH · Traditional | Vanguard Medical Concepts, Inc. | 10/10/2002SE |
| K012678 | Reprocessed Sealed Electrophysiology Diagnostic CathetersNLH · Traditional | Sterilmed, Inc. | 08/14/2002SE |
| K012523 | Reprocessed Electrophysiology Diagnostic CathetersNLH · Traditional | Sterilmed, Inc. | 08/14/2002SE |
| K012708 | Electrophysiology CatheterNLH · Traditional | Alliance Medical Corp. | 08/13/2002SE |
| K012687 | Vanguard Reprocessed Diagnostic Electrophysiology CathetersNLH · Traditional | Vanguard Medical Concepts, Inc. | 08/01/2002SE |
| K012688 | Vanguard Reprocessed Diagnostic Electrophysiology CathetersNLH · Traditional | Vanguard Medical Concepts, Inc. | 07/31/2002SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2615-2026 Class I | Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St.…Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual… | Medline Industries, LP | 05/15/2026Open, Classified |
| Z-2199-2026 Class II | Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | Stryker Sustainability Solutions | 04/10/2026Open, Classified |
| Z-2198-2026 Class II | Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | Stryker Sustainability Solutions | 04/10/2026Open, Classified |
| Z-2197-2026 Class II | Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | Stryker Sustainability Solutions | 04/10/2026Open, Classified |
| Z-2196-2026 Class II | Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | Stryker Sustainability Solutions | 04/10/2026Open, Classified |
| Z-2195-2026 Class II | Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | Stryker Sustainability Solutions | 04/10/2026Open, Classified |
| Z-2194-2026 Class II | Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | Stryker Sustainability Solutions | 04/10/2026Open, Classified |
| Z-2193-2026 Class II | Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | Stryker Sustainability Solutions | 04/10/2026Open, Classified |
| Z-2192-2026 Class II | Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | Stryker Sustainability Solutions | 04/10/2026Open, Classified |
| Z-2191-2026 Class II | Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | Stryker Sustainability Solutions | 04/10/2026Open, Classified |
| Z-2190-2026 Class II | Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | Stryker Sustainability Solutions | 04/10/2026Open, Classified |
| Z-2189-2026 Class II | Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | Stryker Sustainability Solutions | 04/10/2026Open, Classified |
| Z-2188-2026 Class II | Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | Stryker Sustainability Solutions | 04/10/2026Open, Classified |
| Z-2187-2026 Class II | Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | Stryker Sustainability Solutions | 04/10/2026Open, Classified |
| Z-2186-2026 Class II | Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | Stryker Sustainability Solutions | 04/10/2026Open, Classified |
| Z-2185-2026 Class II | CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY…Incomplete seals on sterile product | Stryker Sustainability Solutions | 04/10/2026Open, Classified |
| Z-2184-2026 Class II | CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY…Incomplete seals on sterile product | Stryker Sustainability Solutions | 04/10/2026Open, Classified |
| Z-2183-2026 Class II | BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | Stryker Sustainability Solutions | 04/10/2026Open, Classified |
| Z-2182-2026 Class II | BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | Stryker Sustainability Solutions | 04/10/2026Open, Classified |
| Z-2181-2026 Class II | BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY…Incomplete seals on sterile product | Stryker Sustainability Solutions | 04/10/2026Open, Classified |
| Z-2180-2026 Class II | BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | Stryker Sustainability Solutions | 04/10/2026Open, Classified |
| Z-2179-2026 Class II | BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | Stryker Sustainability Solutions | 04/10/2026Open, Classified |
| Z-2178-2026 Class II | BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY…Incomplete seals on sterile product | Stryker Sustainability Solutions | 04/10/2026Open, Classified |
| Z-2177-2026 Class II | BARD Dynamic Tip Steerable, Product Number 6DYNTP001;Incomplete seals on sterile product | Stryker Sustainability Solutions | 04/10/2026Open, Classified |
| Z-2176-2026 Class II | BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | Stryker Sustainability Solutions | 04/10/2026Open, Classified |
| Z-2175-2026 Class II | BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | Stryker Sustainability Solutions | 04/10/2026Open, Classified |
| Z-2174-2026 Class II | BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETERIncomplete seals on sterile product | Stryker Sustainability Solutions | 04/10/2026Open, Classified |
| Z-1322-2026 Class I | Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St.…These lots of reprocessed catheters may contain small particles of residual material. If affected devices… | Medline Industries, LP | 12/22/2025Open, Classified |
| Z-1321-2026 Class I | Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire…These lots of reprocessed catheters may contain small particles of residual material. If affected devices… | Medline Industries, LP | 12/22/2025Open, Classified |
| Z-1320-2026 Class I | Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable…These lots of reprocessed catheters may contain small particles of residual material. If affected devices… | Medline Industries, LP | 12/22/2025Open, Classified |
| Z-1319-2026 Class I | Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes…These lots of reprocessed catheters may contain small particles of residual material. If affected devices… | Medline Industries, LP | 12/22/2025Open, Classified |
| Z-2612-2025 Class I | Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac…Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual… | Medline Industries, LP | 07/31/2025Open, Classified |
| Z-2611-2025 Class I | Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of…Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual… | Medline Industries, LP | 07/31/2025Open, Classified |
| Z-2610-2025 Class I | Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH…Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual… | Medline Industries, LP | 07/31/2025Open, Classified |
| Z-2460-2025 Class I | Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic…Specific lots of reprocessed electrophysiology catheters may contain small residual particulates. | MEDLINE INDUSTRIES, LP - Northfield | 07/14/2025Open, Classified |
| Z-1460-2025 Class II | Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item…Devices may have higher than expected amounts of bacterial endotoxin. | MEDLINE INDUSTRIES, LP - Northfield | 02/06/2025Open, Classified |
| Z-2268-2024 Class II | Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter…Diagnostic electrophysiology (EP) catheters do not meet testing requirements. | Stryker Sustainability Solutions | 05/10/2024Open, Classified |
| Z-0766-2019 Class II | BW Lasso 2515 ANV eco Variable Diagnostic EP Catheter, REF D134301 Diagnostic…Stryker s Sustainability Solutions division (SSS) has received an increase in reports indicating that an… | Stryker Sustainability Solutions | 12/17/2018Terminated |
| Z-0467-2019 Class II | Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters…Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently… | Stryker Sustainability Solutions | 08/23/2018Terminated |
| Z-2426-2018 Class II | Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter, catalog…Thrombogenicity test results demonstrated that both the test devices (SSS) and control devices (OM) did not… | Stryker Sustainability Solutions | 03/29/2018Terminated |
| Z-0917-2018 Class II | Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic…An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems. | Stryker Sustainability Solutions | 01/02/2018Terminated |
| Z-0916-2018 Class II | Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic…An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems. | Stryker Sustainability Solutions | 01/02/2018Terminated |
| Z-0964-2017 Class II | Reprocessed Electrophysiology Catheter Cables Catalog Number: CB3434CT, D134401…A breach in the sterile packaging may have occurred resulting in potentially non-sterile product. | Stryker Sustainability Solutions | 12/06/2016Terminated |
| Z-0963-2017 Class II | Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT, CR3434CT Ablation catheter…A breach in the sterile packaging may have occurred resulting in potentially non-sterile product. | Stryker Sustainability Solutions | 12/06/2016Terminated |
| Z-0380-2017 Class II | Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology…The EP Catheters may be mislabeled for French size during reprocessing. | Stryker Sustainability Solutions | 10/06/2016Terminated |
| Z-1708-2016 Class II | Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #:…Mislabeled for size | Stryker Sustainability Solutions | 04/28/2016Terminated |
| Z-0340-2014 Class II | Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Catheter…Stryker Sustainability Solutions is recalling the Reprocessed Diagnostic Electrophysiology (EP) Catheters… | Stryker Sustainability Solutions | 10/18/2013Terminated |
| Z-0555-2009 | EP Catheter Model #'s: BIOD6-DR-005-RT BIOD6-DR-010-RT DAI401381 DAI401449 DAI401904…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | Sterilmed Inc | 08/08/2008Terminated |