Wolverine Coronary Cutting Balloon H74939401102250Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729888239), received between Apr 4, 2018 and Oct 21, 2021 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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.

• MalfunctionOct 21, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON BURST. A 10MMX2.25MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST. THE PROCEDURE WAS COMPLETED VIA ALTERNATIVE METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12673690 ↗
• MalfunctionJul 16, 2021Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 95% STENOSED, 15MM COMPLEX, CONCENTRIC AND IRREGULAR TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED FIRST DIAGONAL. THERE WAS TIMI 3 FLOW. A 10MMX2.25MM WOLVERINE CORONARY CUTTING BALLOON WAS INTRODUCED. DURING THE PROCEDURE, WHILE THE BALLOON MARKERS WERE STILL AT THE PROXIMAL END OF THE LESION, THE BALLOON COULD NOT BE PUSHED AND IT WAS NOTED THAT THE BALLOON WAS BROKEN IN HALF WHILE INSIDE THE GUIDE CATHETER. THE PROXIMAL PART OF THE BALLOON SYSTEM WAS REMOVED. THE LESION WAS RECROSSED WITH ANOTHER NON-BOSTON SCIENTIFIC WIRE AND ANOTHER 2.0X15 BALLOON WAS PASSED BEYOND THE WOLVERINE BALLOON. THE BALLOON WAS INFLATED AT THE LOW PRESSURE AND THEN USED TO DRAG WOLVERINE BALLOON BACK INTO THE GUIDE. THE WHOLE SYSTEM INCLUDING THE GUIDE WAS COMPLETELY REMOVED. THERE WAS COMPLETE RETRIEVAL OF THE BROKEN WOLVERINE BALLOON SYSTEM. THE PROCEDURE COULD NOT BE COMPLETED DUE TO INABILITY TO CRACK THE LESION DESPITE TRYING WITH MULTIPLE COMPLIANT AND NON-COMPLIANT BALLOONS. THE LESION COULD NOT BE CROSSED WITH A CUTTING BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12182746 ↗
• InjuryOct 28, 2020Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. THE CHRONIC TOTALLY OCCLUDED (CTO) TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 10MMX2.25MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, THE STENT STILL COULD NOT CROSS EVEN AFTER PRE-DILATATION. SUBSEQUENTLY, THIS BALLOON WAS TRIED AND PREPPED PROPERLY. THE BALLOON WENT THROUGH THE LESION BUT IT DID NOT MODIFY THE PLAQUE ENOUGH AND THE STENT STILL COULD NOT CROSS. THE SAME BALLOON WAS INSERTED AGAIN AND WENT UP TO NOMINAL PRESSURE BUT THE STENT STILL COULD NOT BE DELIVERED. AFTER THE WIRE WAS PULLED, A SHOT WAS TAKEN AND THE VESSEL WAS DISSECTED. THE LESION WAS A CTO AND THE VESSEL HAS RETROGRADE FILLING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 10750155 ↗
• MalfunctionSep 13, 2019Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS FRACTURED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED RIGH CORONARY ARTERY. A 10MM X 2.25MM WOLVERINE CORONARY CUTTING BALLOON WAS INFLATED BUT UPON REMOVAL IT WAS NOTED THAT THE DEVICE WAS BROKEN AND THE BALLOON WAS MISSING. THE MISSING PART ENDED UP BEING IN THE GUIDE AND WAS REMOVED TOGETHER WITH THE GUIDE. STENTING WAS DONE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS GOOD POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9033473 ↗
• InjuryApr 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A VESSEL DISSECTION OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 10MM X 2.25MM WOLVERINE¿ CORONARY CUTTING BALLOON® MONORAIL® WAS ADVANCED DOWN A LEFT INTERNAL MAMMARY ARTERY (LIMA) GRAFT. THE BALLOON WAS INFLATED ONCE. CONTRAST WAS INJECTED AND REVEALED A DISSECTION FROM THE BEGINNING OF THE LIMA GRAFT, ALL THE WAY DOWN TO THE LAD. IT IS UNKNOWN WHETHER THE WOLVERINE OR THE GUIDE CATHETER CAUSED THE DISSECTION. FOUR NON-BSC STENTS WERE DEPLOYED TO TRY TO FIX THE DISSECTION AND IT DID NOT RESTORE THE FLOW. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT DID FINE.

  Patient problems: Intimal Dissection

  MAUDE report 7397419 ↗

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