Wolverine Coronary Cutting Balloon H74939401102000Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729888222), received between Feb 20, 2018 and Sep 14, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Fluid/Blood Leak; Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50757894 ↗
• MalfunctionSep 15, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 10MM X 2.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, WHILE TRYING TO ADVANCE INTO THE LESION THE SHAFT WAS SEVERELY BENT. SUBSEQUENTLY, THE DEVICE WAS REMOVED AND THE SHAFT BROKE IN ATTEMPT TO STRAIGHTEN THE DEVICE. THE SHAFT WAS DAMAGE AT THE PROXIMAL SECTION OF THE CATHETER THAT WAS OUTSIDE THE HEMOSTASIS VALVE. THEY USED GUIDEZILLA II AND THREADER TO GET ENOUGH LUMINAL GAIN TO GET THE BALLOON DELIVERED BUT NOTHING WORKED. THE PATIENT WAS TAKEN OFF THE TABLE AFTER REACHING MAXIMUM SAFE CONTRAST TOTAL AND DID NOT RECEIVE ANY FURTHER TREATMENT OTHER THAN PLAIN OUT BALLOON ANGIOPLASTY, BUT MIGHT BE BROUGHT BACK TO RE-ATTEMPT IF NEEDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10535086 ↗
• MalfunctionFeb 6, 2020Break; Break

  IT WAS REPORTED THAT THE CATHETER BROKE. THE TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED TIBIAL ARTERY. UPON REMOVAL OF A 10MMX2.00MM WOLVERINE CORONARY CUTTING BALLOON, IT WAS NOTED THAT THE CATHETER BROKE AND LEFT THE BALLOON ON THE WIRE. THE FRACTURED BALLOON WAS SNARED AND COMPLETELY REMOVED FROM THE PATIENT'S BODY. A REGULAR BALLOON WAS THEN USED TO DILATE THE VESSEL AND FINISHED THE PROCEDURE SUCCESSFULLY. NO COMPLICATIONS REPORTED AND THE PATIENT REGAINED BLOOD FLOW.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9678730 ↗
• MalfunctionDec 10, 2019Inflation Problem; Inflation Problem

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 21NOV2019. A 10MMX2.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WOULD NOT INFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, THE DEVICE ANALYSIS REVEALED THAT THE BALLOON HAD A CIRCUMFERENTIAL TEAR COMBINED WITH A LONGITUDINAL TEAR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9444277 ↗
• MalfunctionJan 23, 2019Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. DURING THE USE OF A 10 MM X 2.00MM WOLVERINE CORONARY CUTTING BALLOON, A SHAFT BREAK OCCURRED OUTSIDE THE BODY OF THE PATIENT. THE WOLVERINE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT INJURIES RESULTED FROM THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8272265 ↗
• MalfunctionNov 12, 2018Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED AT THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). WHILE PREPARING A 10MM X 2.00MM WOLVERINE CORONARY CUTTING BALLOON, THE SHAFT OF THE BALLOON BROKE OUTSIDE THE BODY OF THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8060309 ↗
• MalfunctionFeb 20, 2018Hole In Material; Material Rupture; Hole In Material; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE AND PINHOLE OCCURRED. THE 80% STENOSED, 12-15MM LONG TARGET LESION WAS LOCATED IN THE MODERATE TORTUOUSITY AND MODERATE CALCIFIED LEFT CIRCUMFLEX ARTERY. A 10MMX2.00MM WOLVERINE¿ CORONARY CUTTING BALLOON® MONORAIL® WAS ADVANCED AND INFLATED THREE TIMES TO 12 ATMOSPHERES FOR 15-20 SECOND. ON THE THIRD INFLATION, THE BALLOON RUPTURED. IT WAS BELIEVED AN OLD PREVIOUSLY PLACED STENT OR A PIECE OF CALCIUM MAY HAVE PUNCTURED THE BALLOON CAUSING IT TO RUPTURE. A 2.5MM X 12MM NC EMERGE WAS USED TO DILATE THE LESION ONE MORE TIME AND THEN A SYNERGY STENT WAS DEPLOYED. POST DILATION WAS PERFORMED AND THE PROCEDURE WAS COMPLETED WITH EXCELLENT OUTCOMES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7283501 ↗

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.