St. Jude Medical, Atrial Fibrillation Division, Inc.

United Statesfrom the FDA registration address FDA establishment FEI 1000139754

Devices: 0
Registrations: FDA
FDA recalls: 21 ongoing

No devices from this company are in the catalogue yet.

Company details

FDA FEI number: 1000139754
Address: One St. Jude Medical Drive, Saint Paul, MN, 55117

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

2017 0
2018 0
2019 0
2020 0
2021 0
2022 0
2023 1
2024 0
2025 0
2026 0

1 initiated before 2017

2023
- 18 Dec 2023 Z-0814-2024 Class II Ongoing When the catheters are used with the EnSiteX EP System, the system does not correctly recognize the catheter as the appropriate product model and instead reads and displays it as a different model. This results in some features specific to the catheter do not appear on the display and the catheter image may also appear inverted. Distribution: Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, DC, DE, FL, GA, IA, IL, KS, MA, MD,…
  Full distribution text
  Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, DC, DE, FL, GA, IA, IL, KS, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, PA, SC, TN, TX, UT, VA, WA, and WV. The country of Canada.
  Submission number: P130026
2009
- 15 Jun 2009 Z-1780-2010 Unclassified (pre-2012) Terminated The firm states that overheating of cardiac tissue is caused by inadequate cooling. The potential exists when the UltraWand is run using off-label cooling methods (gravity saline flow instead of pump) that cooling flow to one or both cells can be decreased based on pressure applied by the physician to the device. To reflect this information to the user, the Atrial Fibrillation Division (AFD) has Distribution: AL, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC,…
  Full distribution text
  AL, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI. OUS to include Australia, Canada, Japan, Korea, Singapore
  Submission number: K080292

This is an FDA establishment record without devices in deviCERTS.