Pacel™ 401771Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 05414734001137), received between Jan 20, 2020 and Nov 18, 2024 — classified as 1 death, 13 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• DeathNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE, A CARDIAC PERFORATION OCCURRED LEADING TO THE PATIENT EXPIRING ONE DAY POST PROCEDURE. ON (B)(6) 2024, A TEMPORARY PACEMAKER WAS IMPLANTED DURING THE VALVE IMPLANT PROCEDURE AND CONNECTED TO AN EXTERNAL PACEMAKER GENERATOR, CONFIRMING CORRECT OPERATION. THE PATIENT WAS THEN TRANSFERRED TO THE ICU. THE FOLLOWING DAY, THE PATIENT EXPERIENCED HEMODYNAMIC DECOMPENSATION AND WAS DIAGNOSED WITH CARDIAC TAMPONADE SECONDARY TO A PERFORATION AT THE SITE OF THE PACEL. THE PATIENT WAS TRANSFERRED TO SURGERY FOR A PERICARDIAL WINDOW PROCEDURE, HOWEVER, THE PATIENT EXPIRED.

  Patient problems: Cardiac Perforation

  MAUDE report 20707527 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A TEMPORARY PACING ELECTRODE IMPLANTATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED REQUIRING MEDICATION ADMINISTRATION TO STABILIZE THE PATIENT. ACCESS WAS OBTAINED VIA THE LEFT FEMORAL VEIN AND A VENOUS SHEATH WAS INSERTED. A TEMPORARY ELECTRODE WAS PLACED IN THE RIGHT VENTRICLE AND A TEMPORARY PACEMAKER WAS CONNECTED. THE PACING FREQUENCY WAS SET TO 60 TIMES/MIN AND THE PACING VOLTAGE WAS SET. IS 5V, FIXED ELECTRODE. AFTER THE TEMPORARY PACEMAKER WAS IMPLANTED, THE HEART RUPTURED AND PERFORATED AND THE PATIENT SUDDENLY SUFFERED FROM CONFUSION, CIRCULATORY COLLAPSE, AND LOW BLOOD PRESSURE. AN ULTRASOUND WAS PERFORMED TO DIAGNOSE THE PERICARDIAL EFFUSION. PRESSOR MEDICATIONS WERE ADMINISTERED TO MAINTAIN BLOOD PRESSURE AND THE PATIENT WAS TRANSFERRED TO A (B)(6) HOSPITAL AND IS CURRENTLY IN STABLE CONDITION. THE PHYSICIAN ALLEGES THE ELECTRODE TIP WAS POSSIBLY HARD AND THE CAUSE OF THE PERFORATION MAY HAVE BEEN DUE TO HIGH TENSION AFTER ELECTRODE IMPLANTATION.

  Patient problems: Cardiac Perforation

  MAUDE report 20232429 ↗
• InjuryFeb 5, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  DURING A TAVR PROCEDURE, A PERICARDIAL EFFUSION RESULTING IN CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. WITH THE CATHETER IN PLACE, THE PATIENT WAS TEMPORARILY PRIMED WHILE THE AORTIC VALVE WAS RELEASED. THE PATIENT BECAME HYPOTENSIVE, AND THE PERICARDIAL EFFUSION WAS SEEN ON FLUOROSCOPY ON THE RIGHT VENTRICULAR SURFACE. THE PATIENT WAS SUBSEQUENTLY SENT TO THE SURGERY DEPARTMENT FOR THORACOTOMY AND A PERICARDIOCENTESIS. IT WAS CONFIRMED THAT THE CORONARY ARTERY PERFORATION HAD OCCURRED IN THE RIGHT VENTRICLE WHERE THE TEMPORARY PULSE ELECTRODE WAS PLACED. IT IS ALLEGED THAT THE TEMPORARY PACING ELECTRODE WAS TOO HARD AND CAUSED MYOCARDIAL PERFORATION AND PERICARDIAL TAMPONADE DURING USE. THE PATIENT IS NOW STABLE.

  Patient problems: Cardiac Perforation

  MAUDE report 18646667 ↗
• InjuryNov 18, 2023Material Separation; Material Separation

  THIS REPORT IS TO INCLUDE THE NAME OF THE PHYSICIAN INVOLVED IN THE REPORTED EVENT.

  Patient problems: Arrhythmia

  MAUDE report 18166767 ↗
• InjuryOct 16, 2023Material Too Rigid or Stiff; Material Too Rigid or Stiff

  DURING A PROCEDURE FOR A PATIENT WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION WITH COMPLETE BLOCK, A PERICARDIAL EFFUSION OCCURRED WHICH REQUIRED A PERICARDIOCENTESIS AND SURGERY TO STABILIZE THE PATIENT. THE PACING CATHETER WAS POSITIONED AS TEMPORARY AND A STENT WAS PLACED ON THE CIRCUMFLEX CORONARY ARTERY, WHEN A DROP IN BLOOD PRESSURE WAS OBSERVED. AN ECHOCARDIOGRAM WAS PERFORMED AND CONFIRMED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS DONE, BUT BLEEDING CONTINUED BECAUSE THE TEMPORARY DEVICE MOVED AND CREATED A SMALL HOLE IN THE WALL. THE PATIENT WAS SENT TO SURGERY IN PARMA. THE PRESENCE OF THE HOLE IN THE VENTRICULAR WALL WAS CONFIRMED AND THE PATIENT STABILIZED. THE PHYSICIAN BELIEVES THE TIP OF THE CATHETER WAS TOO STIFF WHICH MAY HAVE CAUSED THE PERFORATION.

  Patient problems: Cardiac Perforation

  MAUDE report 17944214 ↗
• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION PROCEDURE, A PERFORATION OCCURRED IN THE VENTRICULAR WALL. NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Cardiac Perforation

  MAUDE report 17325448 ↗
• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING AN ICP PROCEDURE, WITH A TEMPORARY PACEMAKER PLACEMENT, A PERFORATION OCCURRED. THE PERFORATION OCCURRED 48 HOURS AFTER BEING PLACED, DURING ECHO GUIDED REMOVAL NEEDING NEODRENALINE. THE PATIENT WAS TAKEN TO SURGERY WHERE THE TAMPONADE WAS TREATED USING A SUBXIPHOID APPROACH.

  Patient problems: Cardiac Perforation

  MAUDE report 17325357 ↗
• MalfunctionApr 7, 2022Material Separation; Material Separation

  THE PATIENT WAS ADMITTED DUE TO MYOCARDIAL ISCHEMIA CAUSED BY A MYOCARDIAL INFARCTION. DURING HOSPITALIZATION, THE MONITORING SHOWED SLOW HEART RATE, AS LOW AS 30 BPM. ON (B)(6) 2020, THE PATIENT UNDERWENT TEMPORARY PACEMAKER IMPLANTATION, AND THE HEART RATE WAS 80-90 BEATS/MIN WHEN THE TEMPORARY PACEMAKER WAS USED. THERE WAS NO ABNORMALITY DURING THE SURGERY. THE ECG MONITORING SHOWED THAT THE HEART RATE WAS 45 BPM. THE PATIENT WAS GIVEN ISOPROTERENOL TO INCREASE THE HEART RATE. THE ECG MONITORING SHOWED THAT THE HEART RATE WAS 60 BPM AND THE TEMPORARY PACEMAKER WAS NOT NEEDED. ON THE EVENING OF THE SECOND POSTOPERATIVE DAY, THE PATIENT'S FAMILY HELPED THE PATIENT TURN OVER THE SLIGHTLY AND FOUND THAT THE TEMPORARY PACEMAKER FELL OFF. THE PATIENT WAS IN CURRENTLY IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14046131 ↗
• InjuryMar 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 2182269-2022-00021. DURING A PERCUTANEOUS VALVE PROCEDURE, TWO EPICARDIAL PERFORATIONS OCCURRED. THE PATIENT BECAME UNSTABLE IMMEDIATELY AFTER INSERTION OF THE PACING CATHETER AND EXPERIENCED BRADYCARDIA AND ANOTHER TRANSITORY PACING CATHETER WAS USED. AN ECHOCARDIOGRAM WAS PERFORMED WHICH REVEALED TWO EPICARDIAL PERFORATIONS. THE PATIENT WAS TAKEN TO SURGERY FOR REPAIR AND IS UNSTABLE IN THE ICU. THERE WERE NO PERFORMANCE ISSUES WITH THE CATHETER.

  Patient problems: Cardiac Perforation; Perforation

  MAUDE report 13918818 ↗
• InjuryJan 14, 2022Material Separation; Material Separation

  DURING A PROCEDURE CONDUCTED TO TREAT A THIRD DEGREE ATRIOVENTRICULAR BLOCK THAT THE PATIENT HAD PRIOR TO THE PROCEDURE, DUE TO A MALFUNCTION WITH THE PACING CATHETER AND NOT BEING ABLE TO USE THE DEVICE, THE PATIENT HAD TO BE GIVEN AN INTRAVENOUS DRIP OF ISOPROTERENOL. INITIALLY A PACING CATHETER WAS WANTED TO BE USED FOR INTRACARDIAC PACING TO HELP INCREASE THE PATIENT'S HEART RATE. DURING APPLICATION, IT WAS FOUND THAT THE CONNECTION BETWEEN THE RED NEGATIVE ELECTRODE AND THE PACEMAKER WAS SEPARATED. MOREOVER, THE OUTER COATING OF THE WIRE DETACHED FROM THE INTERNAL WIRE AND RED ELECTRODE. THE PATIENT WAS IMMEDIATELY GIVEN AN INTRAVENOUS DRIP OF ISOPROTERENOL, AND THE TEMPORARY PACEMAKER ELECTRODE WAS REPLACED FOR HEART RATE ELEVATION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT DUE TO THE FRACTURE OF THE CONNECTION BETWEEN THE RED NEGATIVE ELECTRODE AND THE PACEMAKER. THE PATIENT'S THIRD DEGREE ATRIOVENTRICULAR BLOCK WAS ABLE TO BE TREATED AND THE PATIENT WAS NOTED TO BE STABLE.

  Patient problems: Heart Block

  MAUDE report 13258442 ↗
• InjuryOct 28, 2021Loss of Threshold; Loss of Threshold

  ON (B)(6) 2021, THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT DUE TO BATTERY DEPLETION OF THE ORIGINAL PACEMAKER AND TEMPORARY PACING USING A TEMPORARY PACEMAKER WAS CONSIDERED. DURING THE IMPLANTATION OF THE TEMPORARY PACEMAKER, THE APPROPRIATE PACING POSITION IN THE RIGHT VENTRICLE COULD NOT BE FOUND AND THE PACING THRESHOLD WAS SIGNIFICANTLY INCREASED. THE ISSUE WAS NOT RESOLVED AFTER SEARCHING FOR THE APPROPRIATE POTENTIAL MULTIPLE TIMES. FOLLOWING THE TEMPORARY PACING IMPLANTATION, THE PATIENT WAS NOTED TO BE POORLY DRIVEN BY PACING AND WAS RETURNED TO THE CATHETERIZATION LABORATORY TO ADJUST THE ELECTRODE POSITION, DURING WHICH CARDIAC ARREST OCCURRED AT ONE TIME AND WAS TREATED BY UTILIZING CARDIOPULMONARY RESUSCITATION. ON SEPTEMBER 12, THE PATIENT UNDERWENT AN EMERGENCY PERMANENT PACING IMPLANTATION AGAIN DUE TO INCREASED THRESHOLD BECAUSE THE TEMPORARY PACEMAKER COULD NOT BE DRIVEN. THE PERMANENT PACING ELECTRODE HAD A GOOD THRESHOLD AND A GOOD POSITION. THE PATIENT WAS NOTED TO BE IN A STABLE CONDITION.

  Patient problems: Cardiac Arrest

  MAUDE report 12715002 ↗
• InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS DIAGNOSED WITH ACUTE MYOCARDIAL INFARCTION ON (B)(6) 2020 AND THE PACEL BIPOLAR PACING CATHETER WAS IMPLANTED IN EMERGENCY SURGERY. FOLLOWING THE SURGERY, THE PATIENT EXPERIENCED FATAL ARRHYTHMIA AND VENTRICULAR TACHYCARDIA, WITH A HEART RHYTHM OF 210 BEATS PER MINUTE AND THE PATIENT EXPERIENCED A SHORT-TERM LOSS OF CONSCIOUSNESS. THE PACEL BIPOLAR PACING CATHETER WAS REMOVED AND CARDIOVERSION WAS PERFORMED TO STABILIZE THE PATIENT. THE PATIENT IS IN STABLE CONDITION AND HAS BEEN DISCHARGED.

  Patient problems: Arrhythmia

  MAUDE report 10958391 ↗
• MalfunctionJul 22, 2020Material Separation; Material Separation

  ONE DAY AFTER THE PLACEMENT OF THE TEMPORARY ELECTRODE, THE PROXIMAL LEG WIRE OF THE DEVICE BROKE REQUIRING THE DEVICE TO BE REPLACED. THE PATIENT'S TREATMENT WAS COMPLETED WITH THE REPLACEMENT DEVICE AND THE PATIENT WAS RELEASED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10311062 ↗
• InjuryJul 16, 2020Material Too Rigid or Stiff; Material Too Rigid or Stiff

  TWO DAYS POST PROCEDURE, A RIGHT VENTRICLE PERFORATION WAS NOTED. DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE, THE DEVICE WAS PLACED IN THE RIGHT VENTRICLE. TWO DAYS FOLLOWING THE PROCEDURE, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT, WHERE A RIGHT VENTRICLE PERFORATION WAS NOTED. THE PATIENT EXPERIENCED RAPID HYPOTENSION AND A SHORT CARDIAC ARREST AFTER THE DEVICE WAS REMOVED. AN ECHOCARDIOGRAM REVEALED A PERICARDIAL TAMPONADE FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE PHYSICIAN STATED THE PACING CATHETER FELT HARD FOLLOWING REMOVAL.

  Patient problems: Cardiac Perforation

  MAUDE report 10282665 ↗
• InjuryJul 16, 2020Material Too Rigid or Stiff; Material Too Rigid or Stiff

  TWO DAYS POST PROCEDURE, A RIGHT VENTRICLE PERFORATION WAS NOTED. DURING A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE, THE DEVICE WAS PLACED IN THE RIGHT VENTRICLE. TWO DAYS FOLLOWING THE PROCEDURE, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT, WHERE A RIGHT VENTRICLE PERFORATION WAS NOTED. THE PATIENT EXPERIENCED RAPID HYPOTENSION AFTER THE DEVICE WAS REMOVED. AN ECHOCARDIOGRAM REVEALED A PERICARDIAL TAMPONADE FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE PHYSICIAN STATED THE PACING CATHETER FELT HARD FOLLOWING REMOVAL.

  Patient problems: Cardiac Perforation

  MAUDE report 10282605 ↗
• InjuryJan 20, 2020Fracture; Fracture

  UPON ARRIVAL, THE PATIENT WAS EXHIBITING A MYOCARDIAL INFARCTION, SO A PACING CATHETER WAS USED. THE ELECTROCARDIOGRAM MONITORING OF THE PATIENT SHOWED A THIRD-DEGREE ATRIOVENTRICULAR BLOCK WITH A HEART RATE OF 34 BEATS PER MINUTE. THE CATHETER WAS CHECKED AND THE CIRCUIT WIRE WAS DISCONNECTED AT A THIRD OF THE ELECTRODE INTERFACE. THERE WAS NO TEMPORARY PACING RHYTHM. THE ELECTRODE WAS REPLACED, AND THE ELECTROCARDIOGRAM SHOWED VENTRICULAR PACING RHYTHM.

  Patient problems: Arrhythmia

  MAUDE report 9606829 ↗