N/A 106173PRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741011573), received between Dec 18, 2018 and Dec 12, 2025 — classified as 1 death, 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (6 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

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED BY THE REGISTERED NURSE, MANAGER OF THE INTENSIVE CARE UNIT. FOR THE PACING KIT. INSIDE THE KIT THERE WAS A PACING ELECTRODE CATHETER. WHEN GOING TO INSERT, PROVIDER TESTED BALLOON WHICH WOULD NOT INFLATE. SECOND KIT HAD TO BE OPENED. NOTED THE EXPIRATION DATE FOR NONFUNCTIONING KIT WAS 30NOV2025. NEW KIT HAD DIFFERENT LOT AND EXPIRATION. THEY HAVE SUBMITTED A PREVIOUS PRODUCT CONCERN FOR SAME ISSUE. UNCLEAR IF THIS WAS A LARGER SCALE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23796658 ↗
• MalfunctionDec 12, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED BY THE REGISTERED NURSE, MANAGER INTENSIVE CARE UNIT AT SWEDISH FIRST HILL MEDICAL CENTER, SEATTLE WA, FOR THE PACING KIT. INSIDE THE KIT THERE WAS A PACING ELECTRODE CATHETER. WHEN GOING TO INSERT, PROVIDER TESTED BALLOON WHICH WOULD NOT INFLATE. SECOND KIT HAD TO BE OPENED. NOTED THE EXPIRATION DATE FOR NONFUNCTIONING KIT WAS (B)(6) 2025. NEW KIT HAD DIFFERENT LOT AND EXPIRATION. THEY HAVE SUBMITTED A PREVIOUS PRODUCT CONCERN FOR SAME ISSUE. UNCLEAR IF THIS WAS A LARGER SCALE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23796644 ↗
• MalfunctionJun 7, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT CUSTOMER HAD A PRODUCT FAILURE WITH THE TEMPORARY PACING ELECTRODE CATHETER IN THE INTENSIVE CARE UNIT. THE BALLOON DID NOT INFLATE WHEN PHYSICIAN ATTEMPTED. ALSO STATED THAT THEY HAD THE FAILED COMPONENT IN THEIR OFFICE FOR INVESTIGATION, WHICH WAS A PART OF A KIT THAT THEY DID NOT CARRY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17078840 ↗
• MalfunctionApr 22, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE TEMPORARY PACING ELECTRODE CATHETER HAD DEFECTIVE PACING OR SPACING WIRES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11712093 ↗
• DeathAug 16, 2019Inflation Problem; Leak/Splash; Material Deformation; Leak/Splash

  IT WAS REPORTED THAT THE TEMPORARY PACING ELECTRODE CATHETER WOULD NOT STAY INFLATED DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE DESPITE LOCKING ON THE PROXIMAL END. THE SURGEON NORMALLY USES CATALOG NUMBER 520007P, WHICH HE HAS USED SUCCESSFULLY FOR YEARS, BUT IT IS ON BACKORDER AT THIS TIME. HE HAD TO USE CATALOG NUMBER 106173P AS A REPLACEMENT, WHICH DOES NOT HAVE THE ¿RIGHT HEART CURVATURE¿ LIKE THE PREVIOUS CATHETER HE NORMALLY USES. THE SURGEON HAD TO MANUALLY PLACE A CURVE ON THE DISTAL TIP BECAUSE THIS CATHETER WAS MORE POINTED AND SPHERE-LIKE COMPARED TO THE OTHER CATHETER. AN 84-YEAR-OLD FEMALE UNDERWENT A SCHEDULED TAVR PROCEDURE IN THE CARDIOVASCULAR INTERVENTION LAB ON 23JUL2019 FOR AORTIC STENOSIS. AFTER THE PROCEDURE WAS COMPLETE, WITH WIRES REMOVED AND TWO SHEATHS REMAINING, SHE WAS TRANSFERRED TO THE RECOVERY ROOM. APPROXIMATELY 45 MINUTES LATER, SHE BECAME BRADYCARDIC AND HYPOTENSIVE. SHE WAS TREATED WITH ATROPINE AND VASOPRESSORS WERE STARTED. A BEDSIDE ECHOCARDIOGRAM SHOWED A SMALL PERICARDIAL EFFUSION. THE PATIENT CONTINUED TO DETERIORATE, AND A SECOND BEDSIDE ECHOCARDIOGRAM SHOWED AN INCREASE IN THE EFFUSION. SHE WAS TAKEN TO THE OPERATING

  Patient problems: Bradycardia; Death; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 8903688 ↗
• InjuryAug 15, 2019Inflation Problem; Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE TEMPORARY PACING ELECTRODE CATHETER WOULD NOT STAY INFLATED DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE DESPITE LOCKING ON THE PROXIMAL END. THE SURGEON NORMALLY USES CATALOG NUMBER 520007P, WHICH HE HAS USED SUCCESSFULLY FOR YEARS, BUT IT IS ON BACK ORDER AT THIS TIME. HE HAD TO USE CATALOG NUMBER 106173P AS A REPLACEMENT, WHICH DOES NOT HAVE THE "RIGHT HEART CURVATURE" LIKE THE CATHETER HE NORMALLY USES. THE SURGEON HAD TO MANUALLY PLACE A CURVE ON THE DISTAL TIP BECAUSE THIS CATHETER WAS MORE POINTED, AND SPHERE-LIKE COMPARED TO THE OTHER CATHETER. A 77 YEAR OLD MALE UNDERWENT A SCHEDULED TAVR PROCEDURE IN THE CARDIAC INTERVENTIONAL LAB. THE SURGEON KEPT THE DELIVERY SYSTEM AND THE WIRES IN PLACE AND ORDERED A STAT ECHOCARDIOGRAM AFTER THE VALVE WAS PLACED TO ASSESS FOR A PERICARDIAL EFFUSION. THE SURGEON'S LAST TAVR CASE EXPERIENCED AN EFFUSION AND EXPIRED, REPORTEDLY DUE TO COMPLICATIONS OF THE PROCEDURE ON THE SAME DATE. THE ECHOCARDIOGRAM SHOWED A LARGE PERICARDIAL EFFUSION WITH HYPOTENSION. VASOPRESSORS WERE STARTED AND AN EMERGENT PERICARDIAL WINDOW WAS PERFORMED. WHEN THE PATIENT'S BLOOD PRESSURE STABILIZED, THE DELIVERY

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 8897247 ↗
• MalfunctionDec 18, 2018Inflation Problem

  IT WAS REPORTED THAT THE BALLOON ON THE TEMPORARY PACING ELECTRODE WOULD NOT INFLATE (PRIOR TO BEING INSERTED INTO THE PATIENT). THE DEVICE HAD TO BE REPLACED, WHICH RESULTED IN A SLIGHT DELAY IN THE PROCEDURE.

  Patient problems: No Code Available; No Patient Involvement

  MAUDE report 8177446 ↗