Pacel™ 401764Recalls & reported problems
St. Jude Medical Cardiovascular Division · Flow Directed Pacing Catheter · Class 2
All models of Pacel (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734022521), received between May 6, 2025 and Feb 9, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Separation” (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.
Reports received per month
Most reported problems
Device problems
- Material Separation2
- Inflation Problem1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 9, 2026Material Rupture
IT WAS REPORTED A PACEL FLOW DIRECTED PACING CATHETER WAS BEING USED FOR TRANSCATHETER AORTIC VALVE IMPLEMENTATION, HOWEVER, THE BALLOON COULD NOT BE INFLATED AND WAS FOUND TO BE RUPTURED. PERCUTANEOUS CORONARY INTERVENTION WITH A NEW TEMPORARY PACEMAKER WAS SUCCESSFUL WITHOUT PATIENT COMPLICATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24292618 ↗MalfunctionOct 27, 2025Material Separation; Material Separation
DURING A TAVI (AORTIC VALVE STENOSIS) PROCEDURE, IT WAS OBSERVED THAT THE DISTAL PORTION OF THE CATHETER HAD DETACHED WHILE INSIDE THE SHEATH. THE SHEATH WITH FRAGMENT INSIDE WAS REMOVED FROM THE PATIENT. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE FRAGMENT WAS DISCARDED BY THE HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23391561 ↗MalfunctionMay 6, 2025Inflation Problem; Material Separation; Inflation Problem; Material Separation
DURING THE PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, A PACING CATHETER WAS INSERTED INTO THE PATIENT AND BLOOD RETURNED TO THE SYRINGE. THE CATHETER WAS REMOVED, AND THE TIP OF THE BALLOON WAS FOUND TO BE RUPTURED. THE CATHETER WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21969955 ↗
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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