PacelRecalls & reported problems across all models

We found 9 models of Pacel by St. Jude Medical Cardiovascular Division in the FDA's device registry (GUDID). Together they are named in 52 adverse event reports in the FDA's MAUDE database, received between Sep 5, 2018 and Sep 18, 2026 — classified as 2 deaths, 27 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Material Separation” (10 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Pacel problems

Pacel models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Pacel™ 401763

  ELECTRODE, PACEMAKER, TEMPORARY
  21 reports
• Pacel™ 401771

  ELECTRODE, PACEMAKER, TEMPORARY
  1 death16 reports
• Pacel™ 401767

  ELECTRODE, PACEMAKER, TEMPORARY
  3 reports
• Pacel™ 401764

  ELECTRODE, PACEMAKER, TEMPORARY
  3 reports
• Pacel™ 401762

  ELECTRODE, PACEMAKER, TEMPORARY
  2 reports
• Pacel™ 401770

  ELECTRODE, PACEMAKER, TEMPORARY
  1 death2 reports
• Pacel™ 401772

  ELECTRODE, PACEMAKER, TEMPORARY
  2 reports
• Pacel™ 401761

  ELECTRODE, PACEMAKER, TEMPORARY
  2 reports
• Pacel™ 401769

  ELECTRODE, PACEMAKER, TEMPORARY
  1 report

Recent Pacel adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Material Rupture

  It was reported that the patient was diagnosed with third-degree atrioventricular (AV) block and had an unstable cardiac rhythm, meeting the clinical indications for temporary cardiac pacing. A bedside sterile temporary pacemaker implantation procedure was planned. The cardiologist strictly followed aseptic technique. After removing the Pacel Bipolar Pacing Catheter from the package, the original syringe provided in the kit was used to properly withdraw air and slowly inject the standard volume of 1 mL of air into the balloon at the distal tip of the lead. Immediately after inflation, it was observed that the balloon at the distal tip of the pacing lead had ruptured. The incident occurred during the pre-use, extracorporeal balloon inflation test with the Pacel in contact with the patient¿s blood path during the balloon rupture. There are no indications as to what caused the balloon to burst. A new Pacel Bipolar Pacing Catheter of the same model and batch was used to successfully complete the procedure. The patient remained hemodynamically stable, with no adverse reactions. There was no clinically significant delay in the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50821961 ↗
• MalfunctionAug 26, 2026Leak/Splash; Device-Device Incompatibility

  It was reported that during preparation the physician checked the Pacel Bipolar Pacing Catheter and it worked. The catheter was then pushed through the contamination sleeve (first the colorless side and then through the green side). Since the green opening of the sleeve is very small it damaged the balloon and caused it to leak when inflated. A new Pacel was used to continue the procedure. There were no adverse patient effects. No additional information was provided.Subsequent to the initially filed report, the following information was received: It was reported that during preparation the physician inflated the Pacel Bipolar Pacing Catheter balloon outside the patient and it worked without issue. The catheter was then pushed through the contamination sleeve which is attached to the introducer sheath inserted in the patient. Since the green opening of the sleeve is very small, resistance was felt and the physician removed the catheter from the sleeve. Upon inspection, the balloon of the catheter was noted to be damaged causing the balloon to leak. A new Pacel was used to continue the procedure. There were no adverse patient effects.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50459914 ↗
• MalfunctionAug 26, 2026Leak/Splash; Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50459742 ↗
• InjuryAug 12, 2026Material Too Rigid or Stiff

  It was reported that a Pacel Bipolar Pacing Catheter was implanted due to atrial fibrillation with a slow ventricular rate (bradycardia). There was no vessel preparation and no other devices were involved. Intraoperative testing demonstrated satisfactory pacing parameters. The catheter was secured with pressure dressing, and the patient was transferred back to the ward. On postoperative day 1, 2.5 hours following Pacel electrode extraction, the patient developed hypotension. The patient¿s base rate was 130/90. Bedside ultrasound examination confirmed the presence of pericardial effusion without obvious perforation. Pericardiocentesis and drainage were performed promptly. Following the procedure, the patient's blood pressure increased, and repeat ultrasound confirmed that the pericardial effusion was no longer increasing. A drainage catheter was left in place, and the patient was admitted to the intensive care unit (ICU) for observation. On postoperative day 2, the patient's vital signs remained stable with no significant changes compared to the previous day. On (b)(6) 2026, the patient remains under observation in the ICU due to a small amount of fluid that has continued to leak fr

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 50223215 ↗
• MalfunctionJul 17, 2026Inflation Problem; Failure to Deflate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25856683 ↗
• MalfunctionMay 7, 2026Material Rupture; Communication or Transmission Problem; Difficult to Advance

  IT WAS REPORTED THAT THE PATIENT WAS PLACED IN THE SUPINE POSITION. THE RIGHT FEMORAL VEIN WAS SELECTED AS THE PUNCTURE SITE. AFTER SKIN DISINFECTION AND STERILE DRAPING, LOCAL INFILTRATION ANESTHESIA WAS ADMINISTERED WITH 1% LIDOCAINE. A PUNCTURE NEEDLE WAS INSERTED APPROXIMATELY 1 CM BELOW THE RIGHT INGUINAL GROOVE, AND ACCESS TO THE FEMORAL VEIN WAS SUCCESSFULLY ACHIEVED. A GUIDEWIRE WAS ADVANCED SMOOTHLY, A 6F SHEATH WAS INSERTED, AND THE GUIDEWIRE WAS WITHDRAWN. A PACEL PACING CATHETER WAS THEN INTRODUCED FOR TEMPORARY TRANSVENOUS RIGHT VENTRICULAR PACING. AFTER THE ELECTRODE WAS ADVANCED TO 30 CM, 1 ML OF AIR WAS INJECTED TO INFLATE THE BALLOON. DESPITE REPEATED ADJUSTMENTS OF THE ELECTRODE POSITION, THE PACING CATHETER WAS NOT PACING, AND THE ELECTRODE COULD NOT BE SMOOTHLY ADVANCED INTO THE RIGHT VENTRICLE. AFTER DEFLATION AND WITHDRAWAL OF THE CATHETER, BALLOON RUPTURE WAS NOTED. THE PACING CATHETER WAS REPLACED, AND AFTER REPEATED ADJUSTMENTS, THE ELECTRODE WAS SUCCESSFULLY ADVANCED INTO THE RIGHT VENTRICLE TO A DEPTH OF 80 CM. THE PACING RATE WAS SET AT 60 BEATS PER MINUTE, PACING OUTPUT AT 2.5 V, AND SENSITIVITY AT 5 MV. ELECTROCARDIOGRAM (ECG) MONITORING SHOWED A PACED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25115730 ↗
• MalfunctionApr 9, 2026Inflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT DURING PROCEDURE A PACEL BALLOON ON THE BIPOLAR PACING CATHETER APPEARED TO BE LEAKING AND COULD NOT BE INFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24834870 ↗
• MalfunctionApr 6, 2026Material Rupture

  IT WAS REPORTED A PACEL BALLOON RUPTURED DURING THE PROCEDURE. THERE WAS NO RESISTANCE FELT DURING THE PROCEDURE. A NEW PACEL OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791845 ↗
• MalfunctionApr 3, 2026Difficult to Advance

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE PREPARATION A PACEL CATHETER WAS USED; HOWEVER, BALLOON ADVANCEMENT FAILED. WHILE PASSING THE CATHETER THROUGH THE SHEATH, THE BALLOON COULD NOT PASS THE GREEN HUB. THE CATHETER WAS NOT USED IN THE PATIENT. A NEW PACEL CATHETER WAS OPENED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANALYSIS OBSERVED A BALLOON DETACHMENT. THE DATE OF EVENT WILL BE ESTIMATED AS (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24776920 ↗
• MalfunctionFeb 11, 2026Pacing Problem

  IT WAS REPORTED THAT THE PACEL FLOW DIRECTED PACING CATHETER WAS NOT PACING WHILE THE BALLOON WAS INFLATED. THE PATIENT WAS EXPERIENCING LOSS OF CAPTURE AND BECAME HEMODYNAMICALLY UNSTABLE. THE PHYSICIAN WAS NOTIFIED AND AN ATTEMPT WAS MADE TO REPOSITION THE TRANSVENOUS PACING LINE WITHOUT SUCCESS. THE PACING CATHETER WAS REPLACED TO RESOLVE THE ISSUE. FURTHER INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24314028 ↗
• 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 ↗
• MalfunctionOct 24, 2025Fracture; Improper or Incorrect Procedure or Method; Fracture; Improper or Incorrect Procedure or Method

  WHEN REMOVING A PARCEL CATHETER FROM THE PATIENT IT WAS NOTED THAT THE BLUE COATING SURROUNDING THE PACING LEAD HAD CRACKED EXPOSING THE SILVER WIRE. ON (B)(6) 2025, A PATIENT UNDERWENT SURGERY WITH AORTIC VALVE BIOPROSTHESIS (UPPER SEGMENT INCISION), SINUS OF AORTA REPAIR (ABSCESS REPAIR), AND CARDIOPULMONARY BYPASS. ON (B)(6), DURING REMOVAL, THE BLUE COATING SURROUNDING THE PACING LEAD WAS FOUND TO HAVE CRACKED, EXPOSING THE SILVER WIRE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. PER THE PACE FLOW DIRECTED PACING CATHETER INSTRUCTIONS FOR USE, TEMPORARY PACING LEADS WHICH ARE INDWELLING FOR EXTENDED PERIODS OF TIME (GREATER THAN 72 HOURS) SHOULD BE ROUTINELY EVALUATED AND REPLACED AS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23383179 ↗
• InjuryOct 24, 2025Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE, VEIN ACCESS GAINED WITH A 6FR, AND THE ELECTRODE WAS INSERTED AND BALLOON INFLATED. THE ELECTRODE BECAME STUCK IN A VEIN BRANCH IN THE PELVIS. THE BALLOON WAS DEFLATED; ELECTRODE WAS REMOVED. UPON REMOVAL, THE PHYSICIAN OBSERVED THAT THE DISTAL TIP OF THE CATHETER HAD DETACHED AND WAS LEFT IN THE VEIN BRANCH.

  Patient problems: Foreign Body In Patient

  MAUDE report 23379560 ↗
• MalfunctionAug 26, 2025Material Separation; Material Separation

  DURING TAVI PROCEDURE WHEN THE TEMPORARY PACEMAKER WAS IMPLANTED IN THE PATIENT, AND THE BALLOON IN THE PACING LEAD RUPTURED. THE PACEL WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE HARM TO THE PATIENT. THE DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22900367 ↗

Other St. Jude Medical Cardiovascular Division products

• BRK4 models · 177 reports
• Angio-Seal6 models · 160 reports
• BRK-16 models · 102 reports
• Supreme16 models · 43 reports
• Safire5 models · 31 reports
• Livewire10 models · 30 reports