Wolverine Coronary Cutting Balloon H74939401153500Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 08714729888376), received between Sep 7, 2018 and May 13, 2026 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Break” (10 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.

• MalfunctionMay 13, 2026Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 15MMX3.50MM WOLVERINE CORONARY CUTTING BALLOON WAS USED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE, WHEN THE DEVICE WAS DELIVERED TO THE LESION, IT WAS NOTED THAT THE SHAFT BROKE. THE DEVICE WAS REMOVED FROM THE PATIENT IN TWO PIECES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25158613 ↗
• MalfunctionOct 21, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 15MM X 3.50MM WOLVERINE CUTTING BALLOON CATHETER SHAFT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23351693 ↗
• MalfunctionSep 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED MILDLY TORTUOUS AND MILDLY CALCIFIED CORONARY ARTERY. A 15MM X 3.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION. DURING THE PROCEDURE, THE BALLOON BURST AT 10 ATM FOR 1 SECOND UPON THE INITIAL INFLATION. THE DEVICE WAS REMOVED NORMALLY, AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22976778 ↗
• MalfunctionSep 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED CORONARY ARTERY. A 15MM X 3.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION. DURING THE PROCEDURE, THE BALLOON BURST AT 10 ATM FOR 1 SECOND UPON THE INITIAL INFLATION. THE DEVICE WAS REMOVED NORMALLY, AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22968431 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERFORATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 15MMX3.50MM WOLVERINE CUTTING BALLOON WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION. DURING THE PROCEDURE, UPON INJECTION AFTER INFLATION, A PERFORATION WAS NOTED. THE PATIENT EXPERIENCED PERICARDIAL EFFUSION, BLEEDING, DECREASED BLOOD PRESSURE, AND CARDIAC TAMPONADE. THE PHYSICIAN USED A COVERED STENT TO TREAT THE PERFORATION AND PERFORMED PERICARDIOCENTESIS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS STABLE POST PROCEDURE AND IS EXPECTED TO FULLY RECOVER.

  Patient problems: Cardiac Tamponade; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Perforation; Pericardial Effusion

  MAUDE report 20292501 ↗
• MalfunctionJun 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 15MMX3.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19530351 ↗
• MalfunctionJun 29, 2023Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 80-90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED RIGHT CORONARY ARTERY. A 15MMX3.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE WAS ADVANCED THROUGH THE TORTUOUS PORTION OF THE ARTERY BUT WAS UNABLE TO GET INTO LESION. IT WAS THEN REMOVED AND A GUIDEZILLA II CATHETER-GUIDE EXTENSION WAS INSERTED. IT WAS DIFFICULT TO GET THROUGH THE COLLAR AT FIRST, BUT IT EVENTUALLY GOT THROUGH AND GOT TO THE LESION. HOWEVER, THE BALLOON BURST BEFORE INFLATION COULD BE PERFORMED AT 1 ATMOSPHERE UPON FIRST INFLATION. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17233691 ↗
• MalfunctionOct 11, 2022Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 15MMX3.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE SHAFT WAS DEFECTIVE AND BROKEN. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15581038 ↗
• MalfunctionOct 4, 2022Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY. A 15MMX3.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. THE BALLOON WAS LOADED ONTO A 300CM NON-BSC GUIDEWIRE BUT UPON ADVANCEMENT, THE MID-SHAFT PART OF THE BALLOON SNAPPED IN HALF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15538845 ↗
• MalfunctionMay 18, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY. A 15MM X 3.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE WOLVERINE CORONARY CUTTING BALLOON WAS ADVANCED ONTO THE GUIDEWIRE BUT THE SHAFT BROKE BEFORE IT ENTERED THE HEMOSTASIS VALVE. THE BREAK OCCURRED OUTSIDE THE PATIENT BODY. THE DEVICE WAS SIMPLY PULLED OUT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11845276 ↗
• MalfunctionDec 16, 2020Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT THE SHAFT BROKE. A 15MMX3.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. UPON INTRODUCTION, DEVICE HAD TROUBLE IN TRAVELING THROUGH THE GUIDE AND WHEN PUSHED THAT SHAFT BROKE OUTSIDE PATIENT'S BODY. THE BALLOON NEVER EXITED THE GUIDE INTO THE ARTERY. THE DEVICE WAS PULLED OUT FROM THE GUIDE. THE PROCEDURE COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11018940 ↗
• MalfunctionOct 27, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 15MMX3.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, WHEN THE BALLOON WAS INFLATED, IT WAS NOTED THAT THE BALLOON POPPED EVEN BEFORE REACHING 4ATM AND BLOOD TRAVELED BACK UP INTO THE SHAFT OF THE WOLVERINE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE 70% STENOSED LESION WAS LOCATED IN A TORTUOUS AND MILDY/MODERATELY CALCIFIED ARTERY. THE BALLOON WAS INFLATED ONCE AT 3-4ATM WHEN THE BALLOON POPPED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE PATIENT CONDITION WAS GREAT POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10742068 ↗
• MalfunctionApr 3, 2020Break; Break

  IT WAS REPORTED THAT A BALLOON FRACTURE OCCURRED. A 15MMX3.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE BALLOON WAS BROKEN IN THE VESSEL. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9920663 ↗
• MalfunctionMar 30, 2020Break; Difficult to Advance; Material Deformation; Break; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THE CATHETER SHAFT BROKE. THE TARGET LESION WAS LOCATED IN THE MILD TO MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 15MMX3.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE DEVICE WAS INTRODUCED, IT WAS NOTED THAT IT WOULD NOT PASS THE CURVE OF THE GUIDE CATHETER. THE DEVICE, WHILE INSIDE THE GUIDE CATHETER, WAS SIMPLY REMOVED FROM THE PATIENT'S BODY. THEN, AS THE DEVICE INSIDE THE GUIDE CATHETER WAS MANIPULATED ON THE BACK TABLE, IT WAS NOTED THAT THE SHAFT WAS BROKEN IN TWO PIECES. FURTHERMORE, IT WAS ALSO NOTED THAT THE DEVICE BECAME KINKED WHILE INSIDE THE GUIDE CATHETER. THE DEVICE WAS REMOVED FROM THE GUIDE CATHETER AFTER MANIPULATING ON THE BACK TABLE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9898071 ↗
• MalfunctionOct 2, 2019Difficult to Remove; Difficult to Advance; Material Integrity Problem; Difficult to Remove; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED THAT THE BALLOON WAS DIFFICULT TO RETRIEVE. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 15MMX3.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON WAS USED TO DILATE EXISTING STENTS AFTER INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED. HOWEVER, THERE WAS RESISTANCE WHILE PASSING THE BALLOON THROUGH A 6FR NON-BSC GUIDE CATHETER. SUBSEQUENTLY, THE BALLOON WAS INFLATED TWICE IN THE ARTERY BUT THERE WAS DIFFICULTY IN RETRIEVING THE BALLOON INTO THE GUIDE. THE BALLOON WAS THEN REMOVED WITHOUT INCIDENT BUT WAS DAMAGED IN THE PROCESS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE BALLOON WAS REMOVED VIA THE GUIDE CATHETER AND THAT THERE WERE NO PIECES OF THE BALLOON LEFT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITHOUT ANY INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9146542 ↗
• MalfunctionMay 1, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE HAD OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED ON A 99% STENOSED LESION IN THE PROXIMAL PORTION OF THE RIGHT CORONARY ARTERY. THE 15MM X 3.5MM WOLVERINE CORONARY CUTTING BALLOON RUPTURED ON THE FIRST INFLATION AFTER THREE SECONDS AT SIX ATMOSPHERES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A ANOTHER OF THE SAME DEVICE WITHOUT FURTHER ISSUE OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8571210 ↗
• MalfunctionMar 27, 2019Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 15MM X 3.50MM WOLVERINE CORONARY CUTTING BALLOON WAS USED BUT BROKE DUE TO RESISTANCE OF THE LESION DURING FORWARD PRESSURE. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8456053 ↗
• MalfunctionNov 19, 2018Break; Break

  IT WAS REPORTED THAT A CATHETER BREAK OCCURRED. WHILE USING A 15MM X 3.50MM WOLVERINE CORONARY CUTTING BALLOON, A CATHETER BROKE WHILE IN THE BODY. THE COMPLETE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITHOUT HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8085339 ↗
• MalfunctionSep 7, 2018Mechanical Problem; Mechanical Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED 16 AUG 2018. IT WAS REPORTED THAT A GUIDEWIRE WAS UNABLE TO PASS THROUGH THE GUIDEWIRE LUMEN. THEY USED ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. IT NEVER WENT INTO THE PATIENT'S BODY. HOWEVER RETURNED DEVICE ANALYSIS REVEALED THERE WAS A HOLE IN THE OUTER SHAFT OF THE DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 7856160 ↗

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.