ACUITY® Pro 8105 (UDI 08714729932628)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729932628), received between Jan 29, 2019 and Mar 26, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THIS INNER GUIDING CATHETER WAS DAMAGED WHILE THE PHYSICIAN WAS CUTTING THE SHEATH. THIS GUIDING CATHETER WAS NEVER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18983966 ↗
• MalfunctionMar 18, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THIS INNER GUIDING CATHETER WAS FRACTURED. THIS GUIDING CATHETER WAS NEVER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18926558 ↗
• MalfunctionMar 1, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING PROCEDURE, AFTER THE PHYSICIAN CUT THIS GUIDING CATHETER AWAY, A REMNANT WAS OBSERVED ON THE LEAD BODY OUTSIDE OF THE PATIENT. THE PHYSICIAN TRIED REMOVING THE REMNANT WITH A CUTTER BUT HAD TO REMOVE IT FROM THE LEAD BODY USING A SMALL PAIR OF SCISSORS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18822740 ↗
• InjuryApr 17, 2019Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A LEAD IMPLANT PROCEDURE, IT WAS EVIDENT THROUGH CONTRAST THAT A VERY SMALL PERFORATION HAD OCCURRED IN THE CORONARY SINUS WHEN THE CATHETER WAS INSERTED. THE CONTRAST MEDIUM DISSIPATED BY THE END OF THE PROCEDURE AND THE PHYSICIAN STATED THAT NO FURTHER ACTION WAS NEEDED. THE PATIENT WAS STABLE THROUGHOUT AND FOLLOWING THE PROCEDURE WITH NO ADDITIONAL CONSEQUENCES.

  Patient problems: Perforation

  MAUDE report 8523066 ↗
• MalfunctionJan 29, 2019Material Integrity Problem; Material Integrity Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING EXPLANT, THIS CATHETER HAD A PROBLEM WITH USING THE SPLITTER TOOL TO SPLIT THE HUB OF THE CATHETER. ONCE IT WENT DOWN THE CATHETER, THE PARTS OF THE SHAFT HAD FRAGMENTED AND FRAYED. NOTHING WAS LEFT IN THE PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8286043 ↗