ACUITY® Pro 8103 (UDI 08714729932543)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729932543), received between Nov 16, 2018 and Nov 27, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THIS GUIDING CATHETER BROKE OFF AT THE END WHILE SPLITTING. THE MAILMAN WIRE WAS BENT UPON REMOVAL FROM THE PACKAGE. THIS GUIDING CATHETER WAS REPLACED AND WILL BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23666251 ↗
• MalfunctionNov 25, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THIS ACCESSORY GUIDE CATHETER BROKE OFF AT THE END WHILE SPLITTING DURING LEFT VENTRICULAR LEAD PLACEMENT. IN ADDITION, THE INVOLVED GUIDEWIRE WAS BENT UPON REMOVAL FROM THE PACKAGE. THE CASE WAS THEN PROCEEDED BY PERFORMING A SECOND PLACEMENT. THIS ACCESSORY WAS OUT OF SERVICE AND WILL BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23650178 ↗
• InjuryOct 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UPGRADE PROCEDURE FROM A DUAL-CHAMBER PACEMAKER TO A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P), A HOOK CATHETER AND A 130-DEGREE INTERNAL CATHETER WERE USED. AFTER SLITTING BOTH THE CATHETERS, THE SPIRAL S CATHETER WAS DISLOCATED. AN IRON MAN WIRE WAS ADVANCED THROUGH THE LEAD AND THE LEAD WAS RETRACTED. A NEW HOOK CATHETER WAS ADVANCED OVER THE WIRE AND A PIECE OF THE PREVIOUS INTERNAL CATHETER WAS FOUND IN THE CAROTID SINUS, THE PIECE COULD NOT BE SALVAGE WITH A SNARE CATHETER. THE PIECE OF INTERNAL CATHETER DETACHED AND DISLOCATED INTO A HEPATIC VEIN. AN ATTEMPT TO SALVAGE THE CATHETER VIA THE FEMORAL GROIN WAS ALSO NOT POSSIBLE. THE PHYSICIAN THEN DECIDED TO LEAVE THE PIECE IN THE VEIN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE REMAINING PART OF THE INTERNAL CATHETER WILL RETURN FOR ANALYSIS.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 15612910 ↗
• InjuryNov 3, 2021Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT THE PHYSICIAN FELT THERE WAS AN ISSUE WITH THIS CATHETER BUT WENT AHEAD AND SUTURED THE LEADS. THE PHYSICIAN DID A FLUOROSCOPY AND NOTED THAT THE TIP WAS BROKEN OFF WHILE STILL IN THE POCKET AROUND THE LEAD, THUS, TRIED TO GET IT OFF. ADDITIONAL INFORMATION OBTAINED FROM THE FIELD WHICH INDICATED THAT THE PHYSICIAN HAD ALREADY SUTURED THE LEAD IN PLACE AND WAS SCANNING THE POCKET WHEN THE PHYSICIAN NOTICED THE PIECE STILL ATTACHED TO THE LEAD. AT THAT POINT, THE PHYSICIAN ATTEMPTED TO REACH THE PIECE AND REMOVE IT, BUT WAS ULTIMATELY UNABLE TO REMOVE IT AND IT REMAINS INSIDE THE PATIENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12749789 ↗
• MalfunctionAug 3, 2021Failure to Cut; Material Integrity Problem; Failure to Cut; Material Integrity Problem

  IT WAS REPORTED THAT THIS GUIDE CATHETER WAS USED TO ACCESS THE CORONARY SINUS DURING A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) IMPLANT PROCEDURE, BUT IT WAS BROKEN DURING SLITTING. THIS CAUSED GREAT DIFFICULTY FOR DOCTOR TO CUT THE FINAL PART, WHICH REMAINED ON THE LEFT VENTRICULAR (LV) LEAD. DOCTOR COMMENTED THAT THIS BEHAVIOR SHOULD NOT OCCUR TO THIS KIND OF CATHETERS, AS IT IMPLIES RISK OF DAMAGING THE LEAD AND DISLODGING IT. DELIVERY SYSTEM WAS DISCARDED AT HOSPITAL FACILITIES. THIS CATHETER IS NOT EXPECTED TO BE RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12271446 ↗
• InjuryNov 16, 2018Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE DISTAL TIP OF THIS INNER CATHETER BROKE OFF DURING THE CUTTING PROCESS AND INITIALLY REMAINED LOOSE IN THE OUTER CATHETER. THE BROKEN PIECE WHICH MEASURES APPROXIMATELY 2-3 CM WAS ACCIDENTLY PUSHED INTO THE CORONARY SINUS WITH ANOTHER INNER CATHETER WHERE IT REMAINS. THE PHYSICIAN REPORTED THAT THE CORONARY SINUS WAS LARGE AND THE CATHETER PIECE WAS IN A STABLE POSITION AND DID NOT APPEAR LIKELY TO MOVE AWAY FROM THAT POSITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8079764 ↗