Wolverine Coronary Cutting Balloon H74939401062500Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729888154), received between Oct 10, 2018 and Aug 14, 2026 — classified as 1 injury, 7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient complications occurred.The patient presented for planned percutaneous coronary intervention. The 80% in-stent restenosed target lesion was located from the mid to distal LAD. The target lesion was pre-treated with a 2.50 x 6 mm Wolverine cutting balloon. Following pre-treatment with the Wolverine balloon, a dissection and spasm were observed and were treated with nitroglycerin and a 2.00 x 12 mm Agent DCB balloon inflated to 4 ATM. After treatment with the Agent DCB, the angiographic appearance normalized. The lesion was then successfully treated with additional 3.00 x 12 mm and 2.50 x 20 mm Agent DCB devices. The patient tolerated the procedure well and was discharged home in stable condition.

  Patient problems: Vascular Dissection; Vasospasm

  MAUDE report 50246804 ↗
• MalfunctionFeb 9, 2022Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE PACKAGE SEAL WAS COMPROMISED. A 6MMX2.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING PREPARATION, WHEN THE CUSTOMER ATTEMPTED TO OPEN THE DEVICE PACKAGE, THE INNER PACKAGING SEEMED TO HAVE BEEN SLIGHTLY OPENED AND MIGHT HAVE POSSIBLY BROKEN STERILITY. IT WAS NOTED THAT THE TEAR TAB WAS PARTIALLY INTACT AND ALL SEALS WERE NOT INTACT. THE STAFF DID NOT FEEL COMFORTABLE USING THE DEVICE FOR THE PROCEDURE, AND PULLED ANOTHER OF THE SAME WOLVERINE BALLOON INSTEAD TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13502924 ↗
• MalfunctionOct 2, 2020Break; Break

  IT WAS REPORTED VIA MEDWATCH 3600840000-2020-8060 THAT SHAFT BREAK OCCURRED. DURING PREPARATION OF A 6MM X 2.50MM WOLVERINE CORONARY CUTTING BALLOON, THE BALLOON DELIVERY SYSTEM BROKE IN HALF WHILE BEING LOADED ONTO A WIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10622049 ↗
• MalfunctionAug 20, 2020Break

  ELDERLY FEMALE WITH HISTORY OF HYPERTENSION. PRESENTED TO EMERGENCY DEPARTMENT WITH CHEST PAIN AND TAKEN TO CATH LAB. WHILE PREPARING EQUIPMENT FOR PROCEDURE, THE WIRE TO CUTTING BALLOON SNAPPED OFF AND BROKE. NO HARM TO THE PATIENT. THE WOLVERINE CUTTING BALLOON DELIVERY SYSTEM BROKE IN HALF AS IT WAS BEING LOADED ONTO THE WIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10430516 ↗
• MalfunctionDec 12, 2019Break; Break

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05DEC2019. IT WAS REPORTED THAT HUB BREAK OCCURRED. DURING PREPARATION OF A 6MMX2.50MM WOLVERINE CORONARY CUTTING BALLOON IT WAS NOTED THAT THE BALLOON BROKE OFF AT THE HUB OUTSIDE PATIENT'S BODY. ANOTHER WOLVERINE CUTTING BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO COMPLICATIONS REPORTED AND THERE WAS NO HARM TO THE PATIENT. HOWEVER, DEVICE ANALYSIS REVEALED HYPOTUBE SHAFT BREAK AT 195MM DISTAL FROM THE DISTAL END OF STRAIN RELIEF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9463465 ↗
• MalfunctionApr 1, 2019Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED AN ATHROTOME HAD DETACHED. DURING A PROCEDURE, THE PHYSICIAN WAS USING A 6MM X 2.50MM WOLVERINE CORONARY CUTTING BALLOON INSIDE OF A RESTENOSIS OF A STENT LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. THE WOLVERINE WOULD NOT ADVANCE INTO THE LESION AND SOMEHOW ONE OF THE ATHROTOMES HAD SHEARED OFF. ALL OF THE DEVICE COMPONENTS WERE REMOVED FROM THE PATIENT. ANOTHER WOLVERINE BALLOON WAS USED TO COMPLETE THE CASE WITH NO FURTHER ISSUES AND NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8470702 ↗
• MalfunctionDec 13, 2018Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). A 6MM X 2.50MM WOLVERINE CORONARY CUTTING BALLOON WAS BEING ADVANCED IN TO THE GUIDE CATHETER WHEN THE SHAFT BROKE APPROXIMATELY 20 CM FROM THE HUB. THE WOLVERINE CATHETER NEVER ENTERED THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8162039 ↗
• MalfunctionOct 10, 2018Break; Break

  IT WAS REPORTED THAT A BALLOON CATHETER HAD BROKEN. IT WAS ALSO REPORTED THAT AFTER REMOVING THE 6MMX2.50MM WOLVERINE MR CUTTING BALLOON FROM THE PACKAGING, IT BROKE UPON REMOVAL FROM THE PLASTIC COIL, AS THEY WERE PULLING OUT THE STYLET. THERE WAS NO TORSIONAL FORCE, BUT A ROUTINE OPENING OF THE BALLOON. THIS OCCURRED OUTSIDE THE PATIENTS BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND THERE WAS NO PATIENT INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7952824 ↗

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-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-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-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