Pacel™ 401763Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 05414734007856), received between Sep 5, 2018 and Sep 18, 2026 — classified as 5 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionMar 27, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TEMPORARY PACEMAKER PROCEDURE IN (B)(6) 2025. THE PATIENT HAD TEMPORARY PACEMAKER WIRES TAPED TO THEIR LEG THAT ALLEGEDLY BROKE WHILE GETTING UP. IT APPEARS TO HAVE COME APART AT THE MIDDLE OF THE CATHETER NOT AT AN END OR HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21707654 ↗
• MalfunctionMar 5, 2025

  PATIENT HAD A TEMPORARY PACEMAKER WIRES TAPED TO LEG AND ALLEGEDLY BROKE WHILE GETTING UP. IT APPEARS TO HAVE COME APART AT THE MIDDLE OF THE CATHETER NOT AT AN END OR HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21525365 ↗
• InjurySep 25, 2024Pacing Problem; Material Deformation; Pacing Problem; Material Deformation

  DURING THE OPERATION, IT WAS DISCOVERED THAT THE TEMPORARY CARDIAC PACING ELECTRODE LEAD IMPLANTED IN THE PATIENT HAD DISPLACED AND DISLODGED. THE PATIENT WAS TRANSFERRED TO (B)(6) HOSPITAL FOR PERMANENT PACEMAKER PLACEMENT DUE TO POOR PACING.

  Patient problems: Arrhythmia

  MAUDE report 20300627 ↗
• InjuryMar 22, 2023Pacing Problem; Pacing Problem

  DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE WHEN THE VALVE WAS DEPLOYED, A PREMATURE VENTRICULAR CONTRACTION OCCURRED. DURING THE PROCEDURE, THE TEMPORARY PACING CATHETER FAILED TO CAPTURE, CAUSING THE VALVE TO DEPLOY APPROXIMATELY 2-3 MM DISTAL TO THE INTENDED SITE. A TRANSTHORACIC ECHOCARDIOGRAM AND CINEANGIOGRAPHY WERE PERFORMED WHICH REVEALED A PERIVALVULAR LEAK. IT WAS FELT THAT FAILURE OF THE TEMPORARY PACING CATHETER TO MAINTAIN CAPTURE LED TO THE COMPLICATION / INAPPROPRIATE PLACEMENT OF VALVE. FDA REF: MW5115460.

  Patient problems: Arrhythmia; Valvular Insufficiency/ Regurgitation

  MAUDE report 16590456 ↗
• MalfunctionOct 5, 2022Pacing Problem; Pacing Problem

  DURING THE TEMPORARY PACEMAKER IMPLANTATION PROCEDURE, THE DEVICE WAS UNABLE TO PACE. IN THE CATHERIZATION LABORATORY DUE TO SINUS BRADYCARDIA, IT WAS NOTED THAT THE SURGEON ROUTINELY OPERATED THE PRODUCT AND WAS UNABLE TO PACE THE HEART RHYTHM DURING THE PROCEDURE. THE PRODUCT WAS REPLACED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15545240 ↗
• MalfunctionJul 12, 2022Fracture; Inflation Problem; Material Separation; Fracture; Inflation Problem; Material Separation

  THIS PER IS INITIATED FROM AN ADVERSE INCIDENT REPORT SUBMITTED BY (B)(6) HOSPITAL OF (B)(6) DIRECTLY TO CHINA MEDICAL DEVICE AE REPORTING SYSTEM (HTTP://MAERS.ADRS.ORG.CN). THE SJM NOTIFIED WAS MADE AWARE ON (B)(6) 2022 FROM THE SYSTEM. PLEASE PROVIDE THE FINAL RR DETAILS PER WI 87835. THE NMPA REPORT IS DUE AUG 26, 2022. ON (B)(6) 2022, THE PATIENT UNDERWENT A TEMPORARY CARDIAC PACEMAKER IMPLANT. THE OPERATOR CONNECTED THE TAIL END OF THE BALLOON CATHETER WITH THE EQUIPPED SYRINGE. AFTER IN VITRO INSPECTION, THE BALLOON WAS FREE OF AN AIR LEAK. THE BALLOON CATHETER WAS THEN ADVANCED THROUGH THE SHEATH. AFTER APPROXIMATELY 20 CM HAD BEEN DELIVERED, 1ML OF AIR WAS INJECTED INTO THE BALLOON. AT THAT TIME, THE SOUND OF A BALLOON RUPTURE WAS HEARD. THE BALLOON WAS IMMEDIATELY WITHDRAWN AFTER PUMPING THE AIR BACK THROUGH THE SYRINGE. AFTER WITHDRAWAL, THE BALLOON WAS INSPECTED AND FOUND TO BE DAMAGED. THE PACEMAKER IMPLANTATION WAS NOT SUCCESSFUL AND A POSSIBLE AIR EMBOLISM OCCURRED IN THE VENOUS SYSTEM. THE PROCEDURE WAS STOPPED IMMEDIATELY AND THE PATIENT WAS PLACED IN THE LEFT LATERAL DECUBITUS POSITION AND TRENDELENBURG POSITION FOR OXYGEN INHALATION AND ENHANCED OBSERVATION. PRESE

  Patient problems: Air Embolism; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14990690 ↗
• InjuryFeb 25, 2022Pacing Problem; Pacing Problem

  FOLLOWING THE PLACEMENT OF THE TEMPORARY PACEMAKER, DUE TO POOR ADHERENCE AND THE CATHETER NOT BEING ABLE TO PACE, THE PATIENT EXPERIENCED A DROP IN HEART RATE. THE ECG SHOWED AN ESCAPE HEART RATE, HOWEVER, THE PATIENT'S BLOOD PRESSURE AND OXYGEN SATURATION COULD NOT BE MEASURED. CARDIOPULMONARY RESUSCITATION WAS IMMEDIATELY ADMINISTERED, AND INTRAVENOUS INJECTION OF EPINEPHRINE WAS ADMINISTERED, AND AN ADJUSTMENT OF THE ELECTRODE POSITION OF THE TEMPORARY PACEMAKER WAS CONDUCTED. AFTER SYMPTOMATIC TREATMENT THE PATIENT'S HEART RATE RECOVERED TO 80 BEATS PER MINUTE. THE PACEMAKER HEART RATE, BLOOD PRESSURE, AND OXYGEN SATURATION WERE THEN ALL NOTED TO BE NORMAL AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: Arrhythmia

  MAUDE report 13598982 ↗
• MalfunctionNov 24, 2020Failure to Capture; Loss of Threshold; Failure to Capture; Loss of Threshold

  DURING TAVR PROCEDURE, WHILE RC PACING, THERE WAS LOSS OF CAPTURE RESULTING IN A NEW VALVE HAVING TO BE REDEPLOYED. TROUBLESHOOTING INCLUDED REPLACING THE REMINGTON CABLES, BUT THE ISSUE PERSISTED. THE DEVICE WAS REPLACED, AND THE ISSUE WAS RESOLVED. DUE TO THIS EVENT A NEW VALVE HAD TO BE REDEPLOYED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10894886 ↗
• InjuryNov 18, 2020Loss of Threshold; Loss of Threshold

  DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, THE PACING CATHETER WAS BEING USED FOR HIGH RATE PACING DURING THE AORTIC VALVE DEPLOYMENT. THERE WAS A LOSS OF CAPTURE FROM THE CATHETER, RESULTING IN VALVE EMBOLIZATION, WHICH WAS DIAGNOSED WITH FLUOROSCOPY. FURTHER INFORMATION ABOUT THE EVENT WAS REQUESTED BUT IS NOT AVAILABLE.

  Patient problems: Embolism

  MAUDE report 10859833 ↗
• MalfunctionSep 5, 2018Break

  INITIAL TEMPORARY PACING WIRE WAS OPENED; PRIOR TO INSERTION BALLOON WAS TESTED; BALLOON WAS FOUND TO BE FAULTY; PRODUCT WAS REMOVED FROM TABLE; SECOND TEMPORARY PACER OPENED AND BALLOON TESTED. SECOND ITEM THEN INSERTED. PROCEDURE CONTINUED UNEVENTFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7845449 ↗