Wolverine Coronary Cutting Balloon H74939401103250Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729888277), received between Mar 15, 2023 and Jan 27, 2026 — classified as 2 injuries, 3 malfunctions.

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

• MalfunctionJan 27, 2026Deflation Problem

  IT WAS REPORTED THAT BALLOON SLOW DEFLATION OCCURRED. A 10MM X 3.25MM WOLVERINE CORONARY CUTTING BALLOON MONORAIL WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION. DURING PROCEDURE, IT WAS NOTED THAT BALLOON DEFLATE SLOWER THAN USUAL. THE DEVICE WAS REMOVED NORMALLY. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24191381 ↗
• InjuryJul 30, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE BALLOON WAS DIFFICULT TO REMOVE AND AN ADDITIONAL DEVICE WAS REQUIRED TO REMOVE THE BALLOON. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A 10MM X 3.25MM WOLVERINE CORONARY CUTTING BALLOON MONORAIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT AFTER THE FIFTH TIME THE WOLVERINE WAS DEFLATED, REMOVAL ATTEMPT WAS UNSUCCESSFUL. THE DEVICE WAS DIFFICULT TO REMOVE FROM THE OSTIAL LESION AND DIFFICULT TO GET BACK INTO THE NON-BOSTON SCIENTIFIC GUIDE CATHETER. A GUIDEZILLA WAS ADVANCED OVER THE BALLOON TO CAPTURE AND REMOVE IT IN ONE PIECE. THE BALLOON WAS FULLY DEFLATED. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22669203 ↗
• InjuryJul 3, 2025Break; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Break; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED AND WAS REMOVED BY SNARING. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 10MMX3.25MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS BROKEN ON THE SHAFT BEFORE THE BALLOON. THE DEVICE WAS REMOVED FROM THE GUIDE CATHETER IN MULTIPLE PIECES USING A SNARE AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22401002 ↗
• MalfunctionMay 17, 2023Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT THE SHAFT GOT FRACTURED. THE TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED ARTERY. A 10MMX3.25MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, A RESISTANCE WAS FELT UPON ADVANCING THE DEVICE THROUGH THE GUIDE EXTENSION CATHETER. WHEN THE DEVICE WAS PULLED OUT, IT WAS NOTED THAT THE SHAFT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16946497 ↗
• MalfunctionMar 15, 2023Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 10MMX3.50MM AND A 10MMX3.25MM WOLVERINE CORONARY CUTTING BALLOON WERE SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON WAS INSERTED AND BLOOD RUSHED INTO THE HUB. THE BALLOON WAS REMOVED OVER THE WIRE AND IT WAS NOTED THAT THE SHAFT BROKE IN HALF OCCURRED OUTSIDE THE BODY. THE DEVICE WAS COMPLETELY REMOVED AND INTACT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16545436 ↗

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-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
• 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.