Wolverine Coronary Cutting Balloon H74939401102750Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729888253), received between Jan 11, 2021 and Jul 29, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

6 other recalls cover devices cleared under the same FDA submission (P950020); they may or may not involve this specific model.

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 18, 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.

• MalfunctionJul 29, 2025Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED ARTERY. A 10MMX2.75MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER SHAFT BROKE WHILE DELIVERING AND WAS ABLE TO REMOVE IN TWO PIECES WITHOUT SNARING. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22649972 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SHOCKWAVE LITHOPLASTY COMPARED TO CUTTING BALLOON TREATMENT IN CALCIFIED CORONARY DISEASE: A RANDOMIZED CONTROLLED TRIAL (SHORT-CUT TRIAL). IT WAS REPORTED THAT CARDIAC PERFORATION OCCURRED. ON (B)(6) 2024, THE SUBJECT PRESENTED WITH STABLE ANGINA AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI) USING CUTTING BALLOON ANGIOPLASTY IN THE MID LEFT DESCENDING CORONARY ARTERY (LAD). PRE-PROCEDURE TIMI FLOW WAS I WITH 99% STENOSIS. A 10MMX2.75MM WOLVERINE CUTTING BALLOON WAS SELECTED FOR PROCEDURE. DURING PROCEDURE, DRUG ELUTING STENT WAS IMPLANTED IN THE MID LAD FOLLOWED BY POST-STENT DILATION WITH A NON-COMPLAINT BALLOON. A SMALL CARDIAC PERFORATION OF THE MID LAD WAS NOTED AND WAS TREATED WITH A COVERED STENT AND PROTAMINE. POST PROCEDURE TIMI FLOW WAS III WITH 0% STENOSIS. THE PATIENT WAS DISCHARGED THE SAME DAY.

  Patient problems: Cardiac Perforation

  MAUDE report 21036718 ↗
• MalfunctionMar 2, 2022Break; Break

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10FEB2022. IT WAS REPORTED THAT THE BALLOON BROKE. THE TARGET LESION WAS LOCATED IN THE CALCIFIED DIAGONAL ARTERY. A 10MMX2.75MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BROKE NEAR THE HUB. THE DEVICE WAS PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT A HYPOTUBE BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13656548 ↗
• MalfunctionJun 3, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE CATHETER SHAFT BROKE. THE TARGET LESION WAS LOCATED IN THE TORTUOUS AND MODERATELY CALCIFIED ARTERY. A 10MM X 2.75MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR TREATMENT WITHIN THE TARGET LESION. THE BALLOON WAS INFLATED AND DEFLATED WITHOUT ISSUE. AS THE WOLVERINE CORONARY CUTTING BALLOON WAS BEING WITHDRAWN, IT KINKED AND THEN BROKE INTO TWO PIECES. THE DEVICE WAS PULLED BACK INTO THE GUIDE CATHETER AND FULLY REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11931583 ↗
• MalfunctionJan 27, 2021Break; Break

  IT WAS REPORTED VIA MAUDE REPORT 3600840000-2021-8005 THAT SHAFT BREAK OCCURRED. A 10MM X 2.75MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, UPON ADVANCING THE BALLOON THROUGH THE GUIDE OVER A WIRE, IT WAS NOTED THAT THE SHAFT PROXIMAL TO THE ENTRY POINT SNAPPED IN HALF. THE DEVICE WAS REMOVED COMPLETELY FROM THE GUIDE WITHOUT ANY INTERVENTION OR DEVICES NEEDED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO UNUSUAL HANDLING OF THE BALLOON PRIOR TO ENTRY INTO THE GUIDE AND THE HEMOSTASIS VALVE WAS OPEN AS WELL. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information; No Known Impact Or Consequence To Patient

  MAUDE report 11238011 ↗
• MalfunctionJan 11, 2021Break

  ELDERLY FEMALE WITH HISTORY OF CORONARY ARTERY DISEASE. PROCEDURE IS ELECTIVE STAGED PERCUTANEOUS CORONARY INTERVENTION OF DIAGONAL ARTERY. AS THE WOLVERINE (2.75 X 10 BALLOON) ENTERED THE GUIDE, SHAFT BROKE INSIDE CATHETER UPON ADVANCEMENT. ALL PARTS WERE SUCCESSFULLY REMOVED WITHOUT KNOWN HARM TO PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 11146806 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P950020. One submission often covers many models, so check the product and lot details in each record.

• Z-2138-2013 · Jul 31, 2013 · Terminated
  Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiation: 1) 4.00mm x 15mm FlextomeTM Cutting BalloonTM MonorailTM Microsurgical Dilatation Device, UPN #H74
• Z-2137-2013 · Jul 31, 2013 · Terminated
  Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation: The Peripheral Cutting Balloon Catheters are indicated for Percutaneous Transluminal Angiopla
• Z-0621-2009 · Nov 21, 2008 · Terminated
  Flextome Cutting Balloon Device Over-the-Wire Delivery System, Coronary Atherotomy System, Over-the-Wire Delivery System, Catalog No. CB0340006, 4.00mm, Sterile. Made in Ireland:
• Z-1512-06 · Jul 21, 2006 · Terminated
  Boston Scientific Cutting Balloon Ultra2 Monorail Device, Boston Scientific, One Boston Scientific Place, Natick, MA 01760.
• Z-0410-06 · Dec 7, 2005 · Terminated
  The Peripheral Cutting Balloon Device small Monorail Delivery System features a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface.
• Z-0409-06 · Dec 7, 2005 · Terminated
  The Flextome Cutting Balloon Device consists of a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. When the Flextome Cutting Ball