ACUITY® Pro 8101Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729932468), received between Feb 7, 2019 and Mar 13, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (2 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.

• InjuryMar 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, A DISSECTION OCCURRED IN THE LEFT VENTRICLE. AN EXTENDED HOOK CATHETER (8104) WAS USED TO ACCESS THE CORONARY SINUS (CS), AND THE LEFT VENTRICULAR (LV) LEAD WAS ADVANCED ALONG THE CS USING THE 8104 MODEL. THIS ACUITY PRO CATHETER (8101) WAS CHOSEN TO ADVANCE THE LV LEAD ACROSS A TIGHT TURN IN THE CS. THIS WAS NOT SUCCESSFUL AT FIRST, THEREFORE, CONTRAST WAS INJECTED THROUGH THE 8101 CATHETER TO ASSESS, AND THE DISSECTION WAS CLEARLY VISIBLE ON FLUOROSCOPY. THE PHYSICIAN SUSPECTED THAT THIS CATHETER WAS AT FAULT, CAUSING THE DISSECTION WHEN THE CONTRAST WAS INJECTED AGAINST THE WALL OF THE VESSEL. HOWEVER, IT COULD HAVE BEEN DUE TO THE ATTEMPT TO ADVANCE THE LV LEAD ACROSS THE NARROW VESSEL. THE 8101 MODEL CONTINUED TO BE USED TO ACCESS ANOTHER VESSEL BELOW THE POINT OF DISSECTION, BEFORE BEING EXCHANGED FOR AN 8103 MODEL, WHICH SUCCESSFULLY ENTERED THE CHOSEN VESSEL BRANCH, AND THE LV LEAD WAS SUCCESSFULLY IMPLANTED. THE CRT-D, RIGHT ATRIAL LEAD, AND THE RIGHT VENTRICULAR LEAD WERE ALSO SUCCESSFULLY IMPLANTED. A POST IMPLANT ECHOCARDIOGRAM WAS PERFORMED TO CONFIRM THAT THERE WAS NO SERIOUS FLUID BUILDUP AROUND THE HEART DUE TO THE DISSECTI

  Patient problems: Vascular Dissection

  MAUDE report 16534747 ↗
• MalfunctionNov 2, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THIS CATHETER TORE APART DURING A PROCEDURE TWO CENTIMETER DISTAL TO HUB AND TORE PERPENDICULAR TO CATHETER LENGTH AND CROSS CUT. THE PHYSICIAN HAD NOT STARTED WITH THE CUTTER YET DURING THIS INCIDENT. THE CATHETER WAS NEVER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10775694 ↗
• MalfunctionAug 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PRODUCT WAS RETURNED WITH NO REPORTED PRODUCT PERFORMANCE ISSUES AND NO REPORTED ADVERSE PATIENT EFFECTS. INITIAL ANALYSIS COMPLETED IN OUR POST MARKET QUALITY ASSURANCE LABORATORY IDENTIFIED A PRODUCT PERFORMANCE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8872348 ↗
• MalfunctionApr 26, 2019Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE ON (B)(6) 2019 A GUIDING CATHETER WAS ATTEMPTED TO BE USED TO INSERT THE LEFT VENTRICLE LEAD BUT THE PART AROUND THE TIP GOT LIFTED AT THE BIFURCATION. IT WAS DETERMINED DUE TO SAFETY PRECAUTIONS TO DISCONTINUE USE. THE LEFT VENTRICLE LEAD WAS INSERTED SUCCESSFULLY WITHOUT THE USE OF A CATHETER. NO ADVERSE HEALTH OUTCOMES WERE REPORTED. THIS CATHETER WILL NOT BE RETURNED AS INDICATED DURING THE INITIAL REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8558226 ↗
• MalfunctionFeb 7, 2019Material Integrity Problem; Material Integrity Problem

  BOSTON SCIENTIFIC RECEIVED INFORMATION THAT WHEN SLITTING CATHETER ABOUT TWO INCHES FROM THE DISTAL END, THE CATHETER BROKE AND HAD TO BE SNIPPED WITH SCISSORS AND HEMASTAT. THE CATHETER BROKE INTO MANY PIECES AND WAS NOT RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8314578 ↗