Wolverine Coronary Cutting Balloon H74939401154000Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729888390), received between Apr 18, 2018 and Sep 3, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2025Break; Break

  IT WAS REPORTED VIA MEDWATCH (B)(4) THAT SHAFT BREAK OCCURRED. A 15 MM X 4.00 MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE BROKE APART WHILE IT WAS BEING INTRODUCED IN THE GUIDE CATHETER. BOTH PIECES OF THE CUTTING BALLOON WAS RETRIEVED AND A NEW CUTTING BALLOON AND GUIDE CATHETER WAS USED. PATIENT TOLERATED PROCEDURE WELL. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22953031 ↗
• MalfunctionAug 8, 2025Break

  WHILE UNDERGOING CORONARY INTERVENTION A WOLVERINE CORONARY CUTTING BALLOON BROKE APART WHILE IT WAS BEING INTRODUCED IN THE GUIDE CATHETER. BOTH PIECES OF THE CUTTING BALLOON WAS RETRIEVED AND A NEW CUTTING BALLOON AND GUIDE CATHETER WAS USED. PATIENT TOLERATED PROCEDURE WELL.

  Patient problems: Insufficient Information

  MAUDE report 22748020 ↗
• MalfunctionDec 27, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SHAFT BROKE. THE 72% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND FIBROTIC ARTERY. A 15MMX4.00MM WOLVERINE CORONARY CUTTING BALLOON MONORAIL WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WAS DIFFICULT TO CROSS AND WHILE PUSHING, THE SHAFT BROKE WHILE INSIDE THE GUIDE CATHETER. THE BALLOON WAS REMOVED FROM THE PATIENT'S BODY IN TWO PIECES AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21026872 ↗
• MalfunctionNov 27, 2024Contamination; Packaging Problem; Contamination; Packaging Problem

  IT WAS REPORTED THAT THE DEVICE STERILITY WAS COMPROMISED. A 15MMX4.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING PREPARATION, WHEN EXTERIOR BOX WAS OPENED AND THE INTERNAL PACKAGE REMOVED, IT WAS PERCEIVED THAT THE INTERNAL PACKAGE WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798290 ↗
• MalfunctionJun 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ONE OF THE CUTTING BALLOON BLADES WAS MISSING. A 15MMX4.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. THE PATIENT HAD SIGNIFICANT THROMBUS IN THE RIGHT CORONARY ARTERY. THE PHYSICIAN USED THE NON-BOSTON SCIENTIFIC (BSC) THROMBECTOMY SYSTEM TO REMOVE THE CLOT, HOWEVER, NOT ALL OF THE CLOT WAS REMOVED. A 4.0 WOLVERINE CUTTING BALLOON WAS THEN USED TO CUT THE THROMBUS. POST CUTTING BALLOON, THE PHYSICIAN DISCOVERED ONE OF THE CUTTING BALLOON BLADES IN THE DEBRIS THAT WAS REMOVED WITH THE NON-BSC THROMBECTOMY SYSTEM. IT WAS CONFIRMED THAT THE 4.0 WOLVERINE BALLOON ONLY HAD 3 BLADES REMAINING. NO SUBSEQUENT WORK WAS DONE ON THE VESSEL. NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19480655 ↗
• MalfunctionMay 6, 2024Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON RUPTURED, AND THE BLADE WAS PARTIALLY DETACHED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TO MODERATELY TORTUOUS AND MILD TO MODERATELY CALCIFIED RIGHT CAROTID ARTERY. A 15MMX4.00MM WOLVERINE CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 12 ATM FOR 8 SECONDS. UPON REMOVAL FROM THE BODY, IT WAS FOUND THAT THE BLADE WAS HANGING FROM THE BALLOON AND WAS PARTIALLY DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19248587 ↗
• MalfunctionJul 12, 2023Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS FRACTURED. A 15MMX4.00MM WOLVERINE CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN WAS ADVANCED THE BALLOON THROUGH A 6F GUIDEZILLA GUIDE EXTENSION CATHETER. HOWEVER, THE DEVICE GOT FRACTURED IN THE MID SHAFT WHEN PUSHED. THE BALLOON WAS ABLE PULLED BACK AND THE PROCEDURE WAS COMPLETED USING ALTERNATIVE DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17304118 ↗
• MalfunctionAug 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A BALLOON DETACHMENT OCCURRED. A 15MMX4.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE COURSE OF THE PROCEDURE, IT WAS NOTED THAT THE BALLOON CAME LOOSE OFF THE WIRE DELIVERY SYSTEM AND HAD TO BE SNAGGED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15218167 ↗
• MalfunctionAug 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A BLADE DETACHMENT OCCURRED. A 15MMX4.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON WAS INSERTED AND INFLATED THREE TIMES AT 8ATM AND ONE TIME AT 10ATM. THE DEVICE WAS WITHDRAWN IN FASHION. HOWEVER, UPON REMOVAL, IT WAS NOTED THAT ONE OF THE ATHERETOMES WAS HANGING OFF OF THE SERVICE OF THE BALLOON. THE BALLOON WAS NOT INFLATED AT THE RECOMMENDED INFLATION RATE BUT THE DEVICE DID FUNCTION PROPERLY IN THE VESSEL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12288822 ↗
• MalfunctionJun 4, 2021Break; Difficult to Advance; Material Integrity Problem; Break; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 15MMX4.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE THE DEVICE COULD NOT CROSS THE LESION. THE SHAFT BROKE THE GUIDE CATHETER. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11942493 ↗
• MalfunctionMar 5, 2021Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED AND DYE LEAKED. A 15MMX4.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE SHAFT BROKE PROXIMAL TO THE BALLOON. THE DYE LEAKED BUT THE DEVICE WAS STILL INTACT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11419019 ↗
• MalfunctionFeb 23, 2021Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS VIA RADIAL APPROACH. A 15MM X 4.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT SHAFT BROKE AT THE RX LUMEN ONLY A COUPLE OF INCHES AFTER FULLY INSERTED INTO THE CO-PILOT HEMOSTASIS VALVE. THE DEVICE WAS REMOVED WITH THE GUIDE AND RETRIEVED WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO ADVERSE EVENTS WERE RECORDED AND NO HARM CAME TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11365562 ↗
• MalfunctionDec 9, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BLADES CAME OFF. THE TARGET LESION WAS IN THE LEFT ANTERIOR DESCENDING ARTERY. A 15MMX4.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CUTTING BALLOON BLADES CAME OFF AFTER THE INFLATION. NO COMPLICATIONS REPORTED AND THE PATIENT IS FINE. IT WAS FURTHER REPORTED THE 60% STENOSED TARGET LESION WAS IN A MILDLY TORTUOUS ARTERY. THE DEVICE WAS COMPLETELY REMOVED AS THE BLADE WAS NOT COMPLETELY DETACHED FROM THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9437455 ↗
• MalfunctionJul 2, 2019Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK HAD OCCURRED. DURING A PROCEDURE, THE 15MM X 4.00MM WOLVERINE CORONARY CUTTING BALLOON SHAFT BROKE WHEN THE PHYSICIAN ATTEMPTED TO CROSS THE LESION. THE DEVICE WAS ABLE TO BE REMOVED FROM THE PATIENT'S BODY INTACT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITHOUT FURTHER ISSUE OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8754389 ↗
• MalfunctionApr 18, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 15MM X 4.00MM WOLVERINE CORONARY CUTTING BALLOON MONORAIL WAS IN USE. WHEN THE BALLOON WAS INFLATED, THEY NOTICED CONTRAST LEAKING OUT SO IT WAS ASSUMED TO HAVE RUPTURED OR HAD A LEAK. THE BALLOON WAS MAINTAINING PRESSURE, AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WAS NO PATIENT COMPLICATION AND THE PATIENT STATUS IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7441404 ↗

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