Wolverine Coronary Cutting Balloon H74939401153000Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 08714729888352), received between May 22, 2018 and Sep 1, 2026 — classified as 4 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50550331 ↗
• InjuryJul 28, 2026Break; Difficult to Remove

  It was reported that the balloon wires broke apart.A two 15mmX3.00mm Wolverine Coronary Cutting Balloon were selected for treatment. During the procedure it was noted that the balloon wires broke apart. Removal of the wire percutaneously were unsuccessful. An incision had to be made to remove the broken wires. There were no patient complications reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50059135 ↗
• InjuryJul 28, 2026Break; Difficult to Remove

  It was reported that the balloon wires broke apart.A two 15mmX3.00mm Wolverine Coronary Cutting Balloon were selected for treatment. During the procedure it was noted that the balloon wires broke apart. Removal of the wire percutaneously were unsuccessful. An incision had to be made to remove the broken wires. There were no patient complications reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50059134 ↗
• MalfunctionMar 18, 2026Inflation Problem; Material Separation

  IT WAS REPORTED THAT BALLOON BLADE DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 3.00MM X 15MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, AFTER 3-4 ATTEMPTS, THERE WAS NO DEPLOYMENT AND THERE WERE NO ATHEROTOMES ON THE DEVICE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO COMPLICATIONS AND PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24630431 ↗
• InjuryJan 13, 2025Break; Difficult to Remove; Material Rupture; Break; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE AND SHAFT BREAK OCCURRED, REQUIRING ADDITIONAL DEVICE TO RESOLVE. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MILDLY TORTUOUS MID TO PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 15MMX3.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON WAS INFLATED THREE TIMES AT 20 ATMOSPHERES IN THE MID LEFT ANTERIOR DESCENDING ARTERY. THE BALLOON WAS PULLED BACK TO THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY AND RUPTURED AT 20 ATMOSPHERES FOR 20 SECONDS. IT WAS PULLED BACK INTO THE LEFT MAIN AND GOT STUCK ON THE LEFT MAIN STENT BUT STILL COULD NOT BE PULLED BACK. WHEN THE SHAFT WAS ATTEMPTED TO BE REMOVED, IT BROKE AT 12 CM FROM THE DISTAL TIP. A BALLOON WAS USED TO TRAP THE DETACHED SHAFT IN THE GUIDE CATHETER AND WAS ABLE TO REMOVE IT ALL TOGETHER. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE METHOD. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21139673 ↗
• MalfunctionOct 1, 2024Break; Break

  IT WAS REPORTED THAT THE CATHETER SHAFT BROKE. THE TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS RIGHT CORONARY ARTERY. A 15MM X 3 MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, UPON INSERTION, THE SHAFT OF THE BALLOON BROKE. THE BALLOON NEVER REACHED THE LESION. THE PORTION OF THE DEVICE WAS OUTSIDE OF THE BODY WHEN THE ISSUE OCCURRED AND WAS REMOVED FROM THE PATIENT IN ONE PIECE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20344857 ↗
• MalfunctionJun 26, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BALLOON WAS DIFFICULT TO REMOVE AND ALMOST DETACHED FROM THE SHAFT AND THE GUIDEWIRES WERE PARTIALLY DETACHED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. THE BALLOON WAS INFLATED FOR MULTIPLE INFLATIONS AT 14 TO 16 ATM FOR 12 TO 14 SECONDS. A 15MMX3.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. UPON REMOVAL, THE WOLVERINE BALLOON WOULD NOT COME BACK THROUGH THE CHOICE PT FLOPPY GUIDEWIRE UPON DEFLATION. THE PHYSICIAN TRIED TO PULL DOUBLE NEGATIVE AND TOOK AN EMPTY 20CC SYRINGE AND PULLED NEGATIVE. NEITHER OF THESE TECHNIQUES WORKED. THE PHYSICIAN THEN INFLATED THE WOLVERINE TO 2 ATM AND DEFLATED BUT IT STILL WOULD NOT COME THROUGH TO THE GUIDEWIRE. THE PHYSICIAN THEN PLACED ANOTHER CHOICE PT FLOPPY GUIDEWIRE NEXT TO THE WOLVERINE WITH A 2.5MMX 12MM EMERGE BALLOON CATHETER ONTO THE WIRE. PHYSICIAN INFLATED NEXT TO THE WOLVERINE AND WAS FINALLY ABLE TO NUDGE THE BALLOON ENOUGH TO FULLY RETRACT IT OUT OF THE BODY. PHYSICIAN SAID IT WAS STILL VERY DIFFICULT TO RETRACT. UPON INVESTIGATION, IT WAS NOTED THAT THE TWO WIRES WERE BOTH FRAYED AND PARTIALLY DETACHED AND THE WOLVERINE SEEMED TO ALMOST BE DETACHED FROM THE SHAF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19618602 ↗
• MalfunctionJun 2, 2024Break; Break

  IT WAS REPORTED THAT A DEVICE FRACTURE OCCURRED. A 15MMX3.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE SHAFT WAS BROKEN. THE DEVICE WAS PULLED AND REMOVED INTACT SAFELY. THERE WERE NO PATIENT COMPLICATIONS REPORTED POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19444881 ↗
• MalfunctionJan 31, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE BLADE WAS EXPOSED. A 15MMX3.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BLADE WAS DEFECTIVE AND EXPOSED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16273907 ↗
• MalfunctionMay 11, 2021Break; Break

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29APR2021. IT WAS REPORTED THAT THE SHAFT BROKE IN A LOCATION WHICH WOULD NOT ENTER THE PATIENT. THE TARGET LESION WAS CALCIFIED. A 15MM X 3.00MM WOLVERINE CB MR CUTTING BALLOON WAS INTRODUCED BUT THE SHAFT BROKE ABOUT 8CM FROM THE HUB WHILE TRYING TO CROSS THE LESION. THE DEVICE WAS REMOVED AND THE PROCEDURE COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE SHAFT BREAK OCCURRED IN A LOCATION WHICH COULD ENTER THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11807951 ↗
• MalfunctionJan 11, 2021Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING UNPACKING, IT WAS NOTED THAT THE CATHETER SHAFT WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11149959 ↗
• MalfunctionSep 14, 2020Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT THE DEVICE WAS FRACTURED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 15MM X 3.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. UPON INSERTION, RESISTANCE WAS MET INSIDE THE GUIDE CATHETER AND FORCE WAS EXERTED WHICH CAUSED THE FRACTURE OF THE DEVICE. THE DEVICE WAS REMOVED AND ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO COMPLICATIONS REPORTED AND PATIENT WAS UNAFFECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10527977 ↗
• 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 9957010 ↗
• MalfunctionMar 25, 2020Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT GOT BROKE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE VERY TORTUOUS AND VERY CALCIFIED LEFT MAIN OSTIAL LEFT ANTERIOR DESCENDING ARTERY. A 15MM X 3.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, WHILE ADVANCING INTO THE HEART THE HYPO TUBE GOT KINKED AND EVENTUALLY THE SHAFT BROKE OUTSIDE THE TUOHY. THE DEVICE WAS SIMPLY REMOVED BY PULLING IT OUT AND SLID OUT EASILY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND PATIENT DID VERY WELL POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9879208 ↗
• MalfunctionFeb 4, 2020Break; Break

  IT WAS REPORTED THAT THE BALLOON SHAFT BROKE. A 15MMX3.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON SHAFT BROKE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9668750 ↗
• MalfunctionOct 10, 2018Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT A KINK AND DIFFICULTY LOADING WIRE OCCURRED. THE TARGET LESION WAS LOCATED IN THE HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A 15 MM X 3.00 MM WOLVERINE CUTTING BALLOON WAS USED DURING THE PROCEDURE. THE WOLVERINE WOULD NOT LOAD ON THE WIRE AND BECAME BENT WHILE TRYING TO LOAD IT ONTO THE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THERE WAS NO HARM TO THE PATIENT. HOWEVER, THE DEVICE WAS RETURNED AND ANALYSIS REVEALED A PINHOLE ON THE OUTER SHAFT. BASED ON THE POTENTIAL ROOT CAUSE IDENTIFIED, THE FOLLOWING ATTRIBUTES WERE EXAMINED: A VISUAL EXAMINATION IDENTIFIED THAT THE BALLOON OF THE DEVICE WAS TIGHTLY WRAPPED AND HAD NOT BEEN SUBJECTED TO POSITIVE PRESSURE. AN EXAMINATION OF THE BALLOON MATERIAL, TIP AND MARKERBANDS IDENTIFIED NO ISSUES WHICH COULD POTENTIALLY HAVE CONTRIBUTED TO THIS COMPLAINT. A VISUAL AND MICROSCOPIC EXAMINATION OBSERVED NO DAMAGE TO THE TIP OR BLADES. ALL BLADES WERE PRESENT AND FULLY BONDED TO THE BALLOON SURFACE. THIS WOLVERINE DEVICE IS RECOMMENDED FOR USE WITH A 0.014 INCH (0.36MM) GUIDEWIRE . DURING THE PRODUCT ANALYSIS THE INVESTIGATOR WAS UNABLE TO L

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7954232 ↗
• MalfunctionAug 20, 2018Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT A SHAFT BREAK AND DIFFICULTY CROSSING THE LESION OCCURRED. THE 100% STENOSED, CHRONIC TOTAL OCCLUDED (CTO), TARGET LESION WAS LOCATED IN THE CIRCUMFERENTIAL CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD). A 15 MM X 3.00 MM WOLVERINE CORONARY CUTTING BALLOON WAS ADVANCED AND A SHAFT BROKE DUE TO DIFFICULTY CROSSING SIGNIFICANT CALCIUM. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7798626 ↗
• MalfunctionAug 20, 2018Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT A SHAFT BREAK AND DIFFICULTY CROSSING THE LESION OCCURRED. THE 100% STENOSED, CHRONIC TOTAL OCCLUDED (CTO), TARGET LESION WAS LOCATED IN THE CIRCUMFERENTIAL CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD). A 15MM X 3.00 MM WOLVERINE CORONARY CUTTING BALLOON WAS ADVANCED AND A SHAFT BROKE DUE TO DIFFICULTY CROSSING SIGNIFICANT CALCIUM. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7798455 ↗
• InjuryMay 22, 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 A MILDY TORTUOUS MID RIGHT CORONARY ARTERY. A 15MM X 3.00MM WOLVERINE¿ CORONARY CUTTING BALLOON® MONORAIL® WAS INFLATED AND CAUSED A MODERATE DISSECTION IN THE ARTERY. THE DEVICE WAS REMOVED AND A REGULAR BALLOON CATHETER WAS USED, THEN THE DISSECTION WAS STENTED WITH A NON-BSC STENT. THERE WERE NO FURTHER PATIENT COMPLICATIONS AND THE PATIENT STATUS IS FINE.

  Patient problems: Intimal Dissection

  MAUDE report 7533162 ↗

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.