Wolverine Coronary Cutting Balloon H74939401103500Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08714729888284), received between Nov 14, 2018 and Feb 17, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2026Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE BALLOON BLADE WAS LIFTED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY. A 10MMX3.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON WAS INFLATED AT 12 ATMOSPHERES. DURING REMOVAL, IT WAS FULLY DEFLATED; HOWEVER, THERE WAS DIFFICULTY REMOVING BALLOON FROM THE GUIDE. ONE BLADE DID NOT REWRAP AND APPEARED TO BE STICKING OUT. THE PROCEDURE WAS COMPLETED USING ALTERNATE DEVICE. THERE WERE NO COMPLICATIONS AND PATIENT FULLY RECOVERED POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24370067 ↗
• MalfunctionFeb 11, 2026Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 10MM X 3.50MM WOLVERINE CORONARY CUTTING BALLOON MONORAIL WAS SELECTED FOR USE. DURING WITHDRAWAL OF THE WOLVERINE, IT WAS NOTED THAT THE SHAFT BROKE IN HALF NOT UNTIL IT WAS OUTSIDE OF PATIENT'S BODY. THE DEVICE WAS REMOVED AS NORMAL. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24312134 ↗
• MalfunctionDec 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON BURST. A WOLVERINE CB MR, US 10 X 3.50MM WAS SELECTED FOR TREATMENT OF THE TARGET LESION WHICH WAS 70-80%. DURING THE PROCEDURE, PRIOR TO THE FIRST INFLATION, THE BALLOON WAS NOTED TO BE RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER METHOD, AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23730775 ↗
• MalfunctionOct 30, 2025Break; Difficult to Advance; Material Deformation; Break; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THE BALLOON BROKE AND THE PROCEDURE WAS CANCELED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED CORONARY ARTERY. A 10MMX3.50MM WOLVERINE CORONARY CUTTING BALLOON MONORAIL AND 3.50 X 48MM SYNERGY XD MONORAIL US WERE SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE, IT WAS NOTED THAT DUE TO VERY HEAVY CALCIUM BURDEN IN PROXIMAL VESSEL, DEVICES COULD NOT ADVANCED UNDER EXERTION AND SHAFTS WERE KINKED/BROKEN WHILE ATTEMPTING TO ADVANCE. THE PROCEDURE WAS CANCELED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23423195 ↗
• MalfunctionNov 28, 2024Break; Break

  IT WAS REPORTED VIA MEDWATCH FACILITY (B)(4) THAT THE BALLOON SHAFT BROKE. A 10MMX3.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. AT THE COURSE OF THE PROCEDURE, WHEN PUTTING THE BALLOON IN THE SHAFT, IT BROKE INSIDE THE GUIDE CATHETER. THE BROKEN PART WAS ABLE TO BE REMOVED FROM THE CATHETER AND A NEW BALLOON WAS USED. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20805512 ↗
• MalfunctionNov 15, 2024Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED CORONARY ARTERY. A 10MMX3.50MM WOLVERINE CUTTING BALLOON WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION. AFTER INSERTION AND TRYING TO INFLATE THE BALLOON AT 1 ATM PER SECOND, IT WAS NOTED THAT THE BALLOON LEAKED AND HAD A HOLE IN IT. THE BALLOON WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20698905 ↗
• MalfunctionJun 28, 2024Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT A DEVICE FRACTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED MIDDLE LEFT ANTERIOR DESCENDING ARTERY (MID LAD). A 10MMX3.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT RESISTANCE WAS FELT UPON CROSSING THE LESION WHICH CAUSED THE DEVICE TO FRACTURE. THE DEVICE WAS REMOVED MANUALLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER ALTERNATIVE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19633172 ↗
• MalfunctionJun 19, 2024Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT A DEVICE FRACTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED MIDDLE LEFT ANTERIOR DESCENDING ARTERY (MID LAD). A 10MMX3.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT RESISTANCE WAS FELT UPON CROSSING THE LESION WHICH CAUSED THE DEVICE TO FRACTURE. THE DEVICE WAS REMOVED MANUALLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER ALTERNATIVE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567520 ↗
• MalfunctionFeb 16, 2024Break; Break

  IT WAS REPORTED THAT A DEVICE FRACTURE OCCURRED. A 10MMX3.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE SHAFT OF THE BALLOON SNAPPED NEAR THE HUB. 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 18722612 ↗
• MalfunctionDec 8, 2023Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON DID NOT DEFLATE PROPERLY. A 10 MM X 3.50 MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON WAS INSERTED, ADVANCED TO THE LESION, AND INFLATED. THE BALLOON WOULD NOT PROPERLY DEFLATE ALL THE WAY DESPITE NEGATIVE PRESSURE BEING PULLED VIA INDEFLATOR. EVENTUALLY, THE DEVICE WAS ABLE TO BE REMOVED FROM THE BODY AND AN ADDITIONAL WOLVERINE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18293685 ↗
• 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 16545160 ↗
• MalfunctionJan 6, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED ARTERY. A 10MMX3.50MM WOLVERINE CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, THE DEVICE BROKE AT THE SHAFT UPON INSERTION. THE DEVICE WAS PULLED OUT AND REMOVED WITHOUT ANY ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16117667 ↗
• MalfunctionAug 8, 2022Break; Break

  IT WAS REPORTED THAT THE BALLOON SHAFT GOT BROKE. A 10MMX3.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, UPON INSERTION ON A 6X24 NON-BSC DEVICE, IT WAS NOTED THAT THE SHAFT BROKE APPROXIMATELY 30CM DEEP. THE DEVICE WAS REMOVED COMPLETELY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15184055 ↗
• MalfunctionAug 12, 2021Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT A BALLOON GOT STUCK. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 10MMX3.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE IT WAS NOTED THAT THE BALLOON GOT STUCK AND COULD NOT CROSS THE LESION. THE DEVICE WAS REMOVED AND RE-PREPPED BUT DID NOT RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12315335 ↗
• MalfunctionOct 30, 2020Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE PACKAGE WAS CONTAMINATED. A 10MMX3.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THERE WAS A SLICE IN THE STERILE PACKAGING MAKING THE CUTTING BALLOON UNUSABLE. THE CIRCULATOR NOTICED THE TEAR IN THE PACKAGE AFTER REMOVING IT FROM THE BOX. THE DEVICE WAS NOT INTRODUCED TO THE STERILE FIELD, WAS NOT USED ON THE PATIENT, AND DID NOT DELAY THE CASE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WAS NO DELAY IN THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND NO ADVERSE EVENTS WERE RECORDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10763045 ↗
• MalfunctionSep 10, 2020Break; Break

  IT WAS REPORTED THAT THE BALLOON BROKE UPON REMOVAL. A 10MMX3.50MM WOLVERINE CORONARY CUTTING BALLOON AND 6F GUIDEZILLA II GUIDE EXTENSION CATHETER WERE SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE BALLOON BROKE WHEN TRYING TO REMOVE FROM THE INSIDE OF THE GUIDEZILLA CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10515497 ↗
• MalfunctionApr 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BLADES WERE NO LONGER ON THE BALLOON UPON REMOVAL. A 15MMX3.00MM AND 10MMX3.50MM WOLVERINE CORONARY CUTTING BALLOON WERE SELECTED FOR USE. UPON REMOVAL, IT WAS NOTED THAT THE BLADES WERE NO LONGER ON THE BALLOONS AFTER FLOATED. THE PROCEDURE WAS COMPLETED BY STENTING AND POST DILATING WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9956994 ↗
• MalfunctionMar 6, 2020Break; Break

  IT WAS REPORTED THAT THE CATHETER SHAFT BROKE. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 10MMX3.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE SHAFT OF THE CATHETER BROKE. THE BALLOON NEVER ENTERED THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9802901 ↗
• MalfunctionFeb 6, 2019Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED ON A FOCAL, CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY. THE LESION WAS ATTEMPTED TO BE DILATED WITH NC TREK BALLOONS WITH NO SUCCESS. A 10MMX3.75MM WOLVERINE CORONARY CUTTING BALLOON WOULD NOT CROSS THE LESION AND THE SHAFT BROKE. THIS 10MMX3.50 WOLVERINE CORONARY CUTTING BALLOON WAS THEN ATTEMPTED BUT ALSO WOULD NOT CROSS AND THE SHAFT BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE WITHOUT ISSUE OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8310714 ↗
• MalfunctionDec 4, 2018Break; Break

  IT WAS REPORTED THAT A CATHETER FRACTURE HAD OCCURRED. A 10MM X 3.50MM WOLVERINE CORONARY CUTTING BALLOON CATHETER HAD FRACTURED. IT WAS NOTED THAT THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8131686 ↗
• MalfunctionNov 14, 2018Break; Break

  THE 70% STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 10MM X 3.50MM WOLVERINE CORONARY CUTTING BALLOON WAS USED TO DILATE THE LESION. WHEN THE WOLVERINE WAS ADVANCED THROUGH THE GUIDE INTO THE LESION, THE BALLOON SHAFT BROKE OFF THE MAIN PART OF THE BALLOON. THE BREAK WAS LESS THAN 15CM FROM THE HUB. THE WOLVERINE WAS REMOVED AND A NON BSC DEVICE WAS USED TO REMOVE THE BALLOON COMPONENT AND THE PROCEDURE WAS COMPLETED. NO ADVERSE EVENTS WERE NOTED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8072409 ↗

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-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.