Pacel™ 401772Recalls & reported problems
St. Jude Medical Cardiovascular Division · Bipolar Pacing Catheter · Class 2
All models of Pacel (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734001151), received between Nov 14, 2022 and Nov 14, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Too Rigid or Stiff” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Material Too Rigid or Stiff2
Patient problems
- Cardiac Perforation2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 14, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff
DURING THE PROCEDURE, A TAMPONADE OCCURRED DUE TO THE CATHETER BEING TOO STIFF.
Patient problems: Cardiac Perforation
MAUDE report 15790891 ↗InjuryNov 14, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff
DURING THE PROCEDURE, A TAMPONADE OCCURRED DUE TO THE CATHETER BEING TOO STIFF. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Cardiac Perforation
MAUDE report 15790085 ↗
Other ELECTRODE, PACEMAKER, TEMPORARY devices
- N/A 006173PC. R. Bard, Inc. · ELECTRODE, PACEMAKER, TEMPORARY161 reports
- SWAN-GANZ D200F7Edwards Lifesciences LLC · ELECTRODE, PACEMAKER, TEMPORARY1 recall0 reports
- ETHICON TPW32Ethicon, LLC · ELECTRODE, PACEMAKER, TEMPORARY1 death46 reports
- ETHICON TPW20Ethicon, LLC · ELECTRODE, PACEMAKER, TEMPORARY39 reports
- N/A 520007PC. R. Bard, Inc. · ELECTRODE, PACEMAKER, TEMPORARY33 reports
- Pacel™ 401763St. Jude Medical Cardiovascular Division · ELECTRODE, PACEMAKER, TEMPORARY21 reports
- Pacel™ 401771St. Jude Medical Cardiovascular Division · ELECTRODE, PACEMAKER, TEMPORARY1 death16 reports
- SWAN-GANZ PACING TD CATHETER D205F7Edwards Lifesciences LLC · Electrode, Pacemaker, Temporary13 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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