Data / Medical devices / United States / St. Jude Medical, Atrial Fibrillation Division, Inc.
St. Jude Medical, Atrial Fibrillation Division, Inc.: FDA-registered device maker in Minnetonka, MN, United States, 28 510(k) clearances and 3 PMA approvals
St. Jude Medical, Atrial Fibrillation Division, Inc. is registered with the FDA (registration 2182269) in Minnetonka, MN, United States. It lists 15 device types. The FDA files 28 510(k) clearances and 3 PMA approvals under its listings, the newest dated December 19, 2025. 13 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 2182269
- Address
- 14901 Deveau PL., Minnetonka, MN, United States, 55345
- Owner or operator
- ABBOTT LABORATORIES (1415939)
- Roles
- Manufacturer, Manufacturer for export, Reprocessor, Specification developer
- First device listed
- December 11, 2007
- Registered through
- 2027
- Brand names listed
- Abbott Medical Grounding Pad, Advisor HD Grid Sensor Enabled, High Density Mapping Catheter, Advisor HD Grid X, Sensor Enabled, High Density Mapping Catheter, Agilis NxT Introducer, Agilis NxT Steerable Introducer, Agilis NxT Steerable Introducer, Agilis NxT Steerable Introducer Dual Reach, Steerable Introducer, Agilis NxT Steerable Introducer Dual-Reach, Steerable Introducer and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 23, 2025 | K251211 | ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid Mapping Catheter, Sensor Enabled; Advisor HD Grid X Mapping Catheter, Sensor Enabled; Agilis NxT Steerable Introducer; Agilis NxT Steerable Introducer Dual-Reach | OBJ | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| December 13, 2024 | K243493 | Agilis NxT Steerable Introducer Dual-Reach | DYB | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| June 13, 2024 | K241370 | Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED) | DYB | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| June 30, 2023 | K231588 | ViewFlex Eco Reprocessed ICE Catheter | OWQ | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| May 3, 2023 | K230934 | ViewFlex Eco Reprocessed ICE Catheter | OWQ | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| December 19, 2022 | K222217 | ViewFlex Xtra Reprocessed ICE Catheter | OWQ | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| January 21, 2022 | K203293 | Abbott Medical Grounding Pad, model RF-DGP-IS | GXD | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| July 15, 2015 | K151622 | St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electrophysiology Catheter | DRF | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| April 1, 2015 | K150631 | St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter | DRF | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| September 20, 2011 | K111576 | NT 2000 LESIONING GENERATOR | GXD | Substantially Equivalent | Neuro Therm, Inc. | accessdata.fda.gov |
| May 10, 2011 | K110450 | AGILIS NXT STEERABLE INTRODUCER | DYB | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| October 18, 2010 | K102721 | LIVEWIRE ELECTOPHYSIOLOGY CATHETER | DRF | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| July 16, 2009 | K090955 | SMITH & NEPHEW RF CANNULATE | GXI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 13, 2009 | K081803 | ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM | DRF | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| January 28, 2009 | K083528 | SMITH & NEPHEW BIPOLAR ADAPTER CABLE, MODEL 72200022 | GEI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 9, 2008 | K081645 | AGILIS NXT STEERABLE INTRODUCER, MODEL G408324 | DYB | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| July 12, 2006 | K061363 | AGILIS NXT STEERABLE INTRODUCER | DYB | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| October 26, 2004 | K042375 | SMK, CX, CXE, RCN | GXI | Substantially Equivalent | Technomed Europe | accessdata.fda.gov |
| October 1, 2002 | K022380 | LIVESIRE ELECTROPHYSIOLOGY CATHETER | DRF | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| September 6, 2001 | K011387 | NEUROTHERM, MODEL JK4 | GXI | Substantially Equivalent | Eurolink, LLC | accessdata.fda.gov |
| March 1, 2000 | K000073 | MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA | GXI | Substantially Equivalent | Mercury Medical | accessdata.fda.gov |
| November 5, 1999 | K991486 | ULTRA-CBX | DWZ | Substantially Equivalent | Medcanica, Inc. | accessdata.fda.gov |
| January 26, 1993 | K913940 | RESPONSE(TM) STEERABLE CATHETER | DRA | Substantially Equivalent | Daig Corp. | accessdata.fda.gov |
| March 4, 1992 | K914278 | DAIG ELECTROPHYSIOLOGY CATHETER W/INFUSION LUMEN | DRF | Substantially Equivalent | Daig Corp. | accessdata.fda.gov |
| October 28, 1991 | K914090 | DAIG FAST CATH(TM) INTRODUCER, MODIFICATION | DYB | Substantially Equivalent | Daig Corp. | accessdata.fda.gov |
| September 18, 1989 | K894500 | DAIG ELECTROPHYSIOLOGY CATHETER | DRF | Substantially Equivalent | Daig Corp. | accessdata.fda.gov |
| May 28, 1980 | K800356 | PERMANENT LEAD INTRADUCER | DYB | Substantially Equivalent | Daig Corp. | accessdata.fda.gov |
| July 17, 1979 | K791129 | PERMANENT LEAD INTRADUCER | DYB | Substantially Equivalent | Daig Corp. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 19, 2025 | P250022 | Volt PFA System | QZI | 10 | October 15, 2026 | accessdata.fda.gov |
| January 25, 2012 | P110016 | THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR | OAD | 91 | August 7, 2026 | accessdata.fda.gov |
| May 4, 1999 | P960016 | LIVEWIRE(R) CARDIAC ABLATION SYSTEM | LPB | 89 | August 7, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 30, 2024 | 94613 | Class II | Ongoing | St. Jude Medical Agilis NxT Steerable Introducer, REF 408309 | One lot of product has dilators that are too short and will not extend outside the introducer sheath. | accessdata.fda.gov |
| June 1, 2011 | 59392 | Not yet classified | Terminated | Supreme Electrophysiology Extension Cable, REF 401984, For use with Hexapolar Catheters, Sterile EO, Rx only, St Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55345. Supreme Electrophysiology Extension Cable used to c | St. Jude Medical is recalling a single lot (3334664) of Supreme Electrophysiology Extension Cable which were packaged with a Quadripolar cable instead of a hexapolar Cable. St. Jude Medical has determined that the incorrectly labeled product poses no safety risk since the extension cable can be safely used with a corresponding Quadripolar catheter but cannot | accessdata.fda.gov |
| January 26, 2011 | 57850 | Not yet classified | Terminated | MitraXs" Self Adjusting Atrial Retractor, Sterile EO, Models (REF): A0030/1; A0031/1; A0032/1; A0033/1, Cardio Life Research s.a., Green Hill, Hoge Wei, 16, B-1930 Zaventem, Belgium. Indicted for the retraction of the at | St. Jude Medical Cardiovascular Division is conducting a voluntary recall of all batches and model numbers of the MitraXs Self Adjusting Atrial Retractor. St. Jude Medical has been distributing this product since their acquisition of CLR in late 2008. They have determined that some distributed batches have very small burrs on the polycarbonate material at th | accessdata.fda.gov |
| June 28, 2010 | 56222 | Not yet classified | Terminated | St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 7 cm length,.025" Max Guidewire O.D., Rx, Sterile EO, REF C408524, 100028093. | Potential for a partial or complete separation of the Shaft (sheath) from the hub or a material break in the hub assembly just distal to the hemostasis seal. If either of these were to occur during use, it is likely that fluids would leak around the Introducer hub and strain relief. | accessdata.fda.gov |
| August 17, 2009 | 53121 | Not yet classified | Terminated | St. Jude Medical FAST-CATH Hemostasis Introducer 7F, REF 406702, Length 12 CM, Lot 6372 Max. Guidewire O.D..038", 2010-01, Manufacturer, St. Jude Medical, 14901 DeVeau place, Minnetonka, MN 55345-2126, Sterile EO. Used f | St. Jude Medical has initiated a voluntary recall of two lots of Fast-Cath Hemostasis Introducers-reorder number 406709, lot number 4219 and reorder number 406702, lot number 6372. They discovered that the product lots could contain some items which have been mis-labeled with the incorrect French size. In one case, the pouch label does not correctly identify | accessdata.fda.gov |
| June 24, 2009 | 52457 | Not yet classified | Terminated | SJM Peel Away Introducer, REF 405116, Lot 2694227, Length 14 cm, 9F (3.00 mm), Max Guidewire o.d.038" (.965 mm), contents 5, 2011-08, Manufacturer St Jude Medical 14901 DeVeau Place, Minnetonka, MN 55345-2126 USA, Steril | St. Jude Medical has initiated a voluntary recall of two lots of Peel l Away Introducers. Isolated lots could contain some items that have been mis-labelled with the incorrect French size of the outer box label. Some 9F products have been labelled as 7F and vice versa. Only the outer box label is affected by this error, the labels on the individual product p | accessdata.fda.gov |
| June 5, 2008 | 48740 | Not yet classified | Terminated | The St. Jude Medical Livewire TC" Ablation Catheter, 8mm Tip w/Thermocouple & Thermistor REF 402196, Length 115 cm, Lot 2056960, Manufacturer St. Jude Medical 14901 DeVeau Place, Minnetonka, MN 55345-2126 USA, Sterile EO | St. Jude Medical has initiated a recall of one lot of Livewire TC" Ablation Catheter. The product was mis-labelled as having an 8 mm tip instead of 4 mm tip. This could potentially result in elevated temperatures and formation of coagulum at the tip electrode. If this coagulum were to detach from the product, the worst case this could potentially result in e | accessdata.fda.gov |
| October 5, 2006 | 36605 | Not yet classified | Terminated | FastCath Transseptal Catheter Introducers with Hemostasis Valve, DAIG division of St. Jude Medical, Minnetonka, MN, consists of a radiopaque sheath and dilator; Product # 406850. | Limited number of FastCath Transseptal Catheter Introducers (REF #406850) are susceptible to the irrigation extension tube on the side port becoming disconnected when a pull force is applied. | accessdata.fda.gov |
| June 7, 2006 | 35819 | Not yet classified | Terminated | The affected device is labeled Angio-Seal Vascular Closure Device 6F VIP Platform, model 610130. The recalled product is the 6 French model size. | The Angio Seal VIP 6F devices were incorrectly packaged with a 0.038'' guidewire vs. the required 0.035'' guidewire. | accessdata.fda.gov |
| April 14, 2006 | 35300 | Not yet classified | Terminated | St. Jude AGILIS Steerable Introducer, Reorder number 408304 and 408308 (Australia). Sterile EO. St. Jude Medical Daig Division, Inc., Minnetonka, MN 55345-2126 USA. This St. Jude Medical (SJM) Agilis Steerable Catheter I | St Jude Medical has determined that a limited number of Agilis Steerable Introducers manufactured in late 2005 are susceptible to the hemostasis hub leaking or separating from the handle. The risks that exist are related to the loss of hemostasis through the Agilis introducer and/or the possibility of air or foreign body being introduced into the patient wit | accessdata.fda.gov |
| September 20, 2005 | 33702 | Not yet classified | Terminated | Sheath Obturator, introducer, catheter. Obturator Accessory Kit Reorder number 406405, a 6 Fr, 15 cm length Obturator supplied as a 10-pack box with 10 Individually packaged Obturators. Sterile EO. Single use. St. Jude m | A lot of product contains a 6F Obturator with a hub that is incorrectly marked as 5 instead of the appropriate 6. The Obturator is correctly sized (6F) per the labeling on both the sterile bag and shelf carton. | accessdata.fda.gov |
| August 22, 2005 | 33329 | Not yet classified | Terminated | Angio-Seal Vascular Closure Device. Ref 610109. 6F STS Platform. Sterilized by gamma radiation. For single use only. St. Jude Medical, Daig Division, Inc., Minnetonka, MN 55345-2126, USA. | Mispackaging-Some Angio-Seal 6F STS Vascular Closure Devices from Lot no. 1146548 have been incorrectly packaged with a 0.035' guidewire instead of a 0.032' guidewire. | accessdata.fda.gov |
| August 4, 2004 | 29848 | Not yet classified | Terminated | Telesheath Left Atrial Introducer System Right Superior. Telesheath Catheter Two-Piece Introducer Kit with Hemostasis Valve. Right Superior Reorder #407900. The product is packaged in an open, semi-rigid plastic tray, wh | St. Jude Medical received two complaints from customers involving the Telesheath Left Atrial Introducer System side arm detaching from the hub of the inner sheath. Subsequent testing of Telesheath inventory at St. Jude Medical indicated that the side arm from the inner sheath can detach during routine handling and manipulation, and occurs on a random basis. | accessdata.fda.gov |
Compare with other makers
- All makers of Generator, Lesion, Radiofrequency
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- All makers of Probe, Radiofrequency Lesion
- All makers of Cable, Electrode
- All makers of Catheter, Electrode Recording, Or Probe, Electrode Recording
Updated October 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.