Wolverine Coronary Cutting Balloon H74939401102500Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08714729888246), received between Oct 8, 2018 and Mar 23, 2026 — classified as 3 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Nonstandard Device; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 10MMX2.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED DURING FIRST INFLATION. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY, AND PROCEDURE WAS COMPLETED WITH A NEW BALLOON. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24671119 ↗
• InjuryJan 31, 2025Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTY AND BALLOON SHAFT BREAK OCCURRED RESULTING IN DEVICE FRAGMENT REMAINING IN THE PATIENT. THE MORE THAN 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TO MODERATELY CALCIFIED LEFT MAIN ARTERY. A 10MMX2.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED OF A LEFT MAIN WITH EXISTING STENTS AND IN-STENT RESTENOSIS PRESENT. AFTER SEVERAL FAILED ATTEMPTS TO DELIVER MULTIPLE DEVICES, AN UNDERSIZED NON-COMPLIANT BALLOON WAS SUCCESSFULLY DELIVERED TO THE LESION FOR DILATATION. SUBSEQUENTLY, A 2.5MM WOLVERINE BALLOON WAS DELIVERED TO THE LESION FOR FURTHER DILATATION. AFTER INFLATION, FRICTION WAS ENCOUNTERED WHEN ATTEMPTING TO REMOVE THE DEVICE. NEGATIVE PRESSURE WAS APPLIED TO THE BALLOON TO REDUCE THE DEVICE PROFILE WHICH DID NOT AID IN REMOVAL OF THE DEVICE. FURTHER ATTEMPTS TO REMOVE INCLUDING SHEATHING OF THE DEVICE WITHIN A GUIDE EXTENSION WERE ATTEMPTED BUT FAILED. ADDITIONAL TRACTION WAS APPLIED TO THE DEVICE AT WHICH POINT THE BALLOON BECAME DETACHED FROM THE DEVICE SHAFT. IT WAS DECIDED THAT ENTRAPPING THE DEVICE TO PREVENT EMBOLIZATION WAS THE SAFEST METHOD TO RESOLVE ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21288068 ↗
• 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 WAS FRACTURED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 10MMX2.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION. DURING THE PROCEDURE, IT WAS NOTED THAT THE MID SHAFT OF THE BALLOON WAS FRACTURED INTO TWO IN THE GUIDE. BOTH PIECES OF THE BALLOON WAS FULLY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21026877 ↗
• MalfunctionJun 4, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE BALLOON NOSE TIP WAS BROKEN. A 10MMX2.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING PREPARATION, UPON LOADING INTO THE WIRE, IT WAS NOTED THAT THE BALLOON NOSE TIP WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19461981 ↗
• MalfunctionMay 22, 2024Break; Break

  IT WAS REPORTED THAT THE CATHETER SHAFT BROKE. A 10MMX2.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER SHAFT FRACTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19373619 ↗
• MalfunctionDec 26, 2023Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS FRACTURED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED ARTERY. A 10MMX2.50MM WOLVERINE CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON WAS LOADED ONTO A RUN THROUGH AND THE DOCTOR WENT TO ADVANCE THROUGH THE COPILOT WHEN THE MID SHAFT GOT SEPARATED. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS OUTSIDE OF THE BODY AT THE TIME OF THE EVENT AND IT NEVER ENTERED THE BODY OF THE PATIENT AS THIS WAS NOTED DURING PREPARATION. ALSO, THE BREAK WAS ROUGHLY 30-40% UP THE SHAFT FROM THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18395174 ↗
• MalfunctionOct 24, 2023Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS FRACTURED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ARTERY. A 10MMX2.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, UPON INTRODUCTION OF THE DEVICE, IT WAS NOTED THAT THE DEVICE WAS FRACTURED. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17996693 ↗
• MalfunctionMar 15, 2022Break; Break

  IT WAS REPORTED THAT THE SHAFT BROKE. A 10MMX2.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE SHAFT BROKE INSIDE THE GUIDE CATHETER AS THE WOLVERINE CORONARY CUTTING BALLOON WAS BEING INTRODUCED WITHIN THE GUIDING CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13769901 ↗
• MalfunctionJan 27, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED RIGHT CORONARY ARTERY. A 10MM X 2.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE WAS USED AFTER COMPLETING THE WIRING OF THE CHRONIC TOTAL OCCLUSION, ROTABLATION AND CROSSING A 2.0X40 BALLOON. SUBSEQUENTLY, THE DEVICE WAS ADVANCED THROUGH THE GUIDE TO THE PROXIMAL CAP OF THE LESION AND WHILE THE PHYSICIAN WAS TRYING TO DELIVER IT, THE SHAFT OUTSIDE OF THE BODY SNAPPED IN HALF. THE PROXIMAL PORTION ABOUT 20CM FROM THE INFLATION PORT WAS FRACTURED. THE DEVICE WAS PULLED OUT FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND STENTING. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11238480 ↗
• InjuryDec 9, 2020Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT THE BALLOON BECAME STUCK IN THE LESION AND THE SHAFT SPLIT IN HALF. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED. THE TARGET LESION WAS LOCATED IN A VERY DISEASED AND CALCIFIED IN-STENT RESTENOSIS OF THE PROXIMAL RAMUS/LEFT MAIN ARTERY. DURING PROCEDURE, A 10MMX2.50MM WOLVERINE CORONARY CUTTING BALLOON WAS ADVANCED SEVERAL TIMES. IT WAS NOTED THAT THE WOLVERINE CUTTING BALLOON MAY HAVE BEEN UNDERSIZED DUE TO THE EXTREME DISEASE. WHEN TRYING TO REMOVE THE WOLVERINE CUTTING BALLOON, IT WAS NOTED THAT THE DEVICE WAS STUCK IN THE LESION AND THEY HAD TO PULL TO GET IT OUT. WHEN THEY PULLED THE BALLOON THE SHAFT SPLIT IN HALF. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE BALLOON. FINALLY THEY USED AN NC EMERGE BALLOON TO TRAP THE DISTAL SHAFT OF THE WOLVERINE CUTTING BALLOON INTO THE GUIDE AND THEY WERE ABLE TO PULL EVERYTHING OUT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10976596 ↗
• MalfunctionNov 18, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 10MMX2.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE SHAFT BROKE IN HALF, 25CM FROM THE HUB WHEN INSERTED INTO THE VESSEL. THE BROKEN PART WAS OUTSIDE THE PATIENT'S BODY AND WAS PULLED OUT BY HAND. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10860761 ↗
• MalfunctionMay 22, 2020Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24APR2020. IT WAS REPORTED THAT THE STYLET WAS DIFFICULT TO REMOVE. A 10MMX2.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE IN A PERCUTANEOUS CORONARY INTERVENTION. DURING PREPARATION, THE STYLET WAS DIFFICULT TO REMOVE WHEN THE PHYSICIAN WENT TO PULL THE STYLET OUT TIGHTNESS WAS FELT. SUBSEQUENTLY, WHEN THE DEVICE WAS FINALLY GOT IT OUT, IT ALMOST LOOKS LIKE THE TIP OF THE BALLOON WAS NOT THERE. THE PHYSICIAN WAS ABLE TO THREAD THE WIRE TO BACKLOAD IT, BUT THE WIRE WAS UNABLE TO ADVANCE THE THROUGH THE BALLOON. THEN, THE DISTAL AREA OF THE LUMEN WAS DAMAGED AND CLOSED TO THE TIP OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED PURPLE TIP DETACHMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10082554 ↗
• MalfunctionNov 19, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 10MM X 2.50MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED AT 10 ATM, WHICH IS LESS THAN THE RATE OF BURST PRESSURE FOR THIS PRODUCT. THE DEVICE WAS THEN REMOVED AND COMPLETED THE PROCEDURE WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9342679 ↗
• MalfunctionOct 24, 2019Break; Break

  IT WAS REPORTED THAT THE CATHETER SHAFT BROKE. THE TARGET LESION WAS LOCATED IN LEFT ANTERIOR DESCENDING ARTERY. A10MMX2.50MM WOVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE BALLOON WAS INSERTED IN TO THE GUIDE CATHETER, IT WAS NOTED THAT THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9234997 ↗
• InjuryJun 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBOSIS AND CHEST PAIN OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE VERY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LENGTH WAS ABOUT 23MM. THE VESSEL SIZE WAS APPROXIMATELY 25MM IN DIAMETER AND THE PATIENT WAS REFERRED FOR AN ATHERECTOMY WHERE A NON BSC DEVICE WAS USED. AFTER THE ATHERECTOMY WAS DONE, A 10 MM X 2.50 MM WOLVERINE CORONARY CUTTING BALLOON WAS ADVANCED TO DILATE THE PROXIMAL LAD AND WAS INFLATED TWICE FOR 15 SECONDS AT NOMINAL PRESSURE AND RESULTED IN A TIMI 3 FLOW. A 2.50 X 24 SYNERGY STENT WAS ADVANCED AND IMPLANTED IN THE PROXIMAL LAD. A TIMI 3 FLOW RESULTED AFTER THE CASE AND EVERYTHING WAS OPEN. THE PATIENT WAS TAKEN OFF THE TABLE AND APPROXIMATELY 30 MINUTES LATER, THE PATIENT WAS HAVING CHEST PAIN. THE PATIENT WAS BROUGHT BACK TO THE CATH LAB AND A THROMBUS DISTAL TO THE STENT WAS NOTICED. A BALLOON DEVICE WAS USED TO INFLATE THIS AREA, AND THE PATIENT WAS GIVEN HEPARIN TO GET THE ACTIVATED CLOTTING TIME (ACT) UP ABOVE 300. AN ASPIRATION CATHETER WAS USED AND PUMPED UP AND RESULTED IN TIMI 3 FLOW AGAIN. THE PATIENT WAS STABLE AND DOING FINE. THE ACT THAT WAS ACHIEVED DURING THE PROCEDURE W

  Patient problems: Chest Pain; Thrombosis

  MAUDE report 8684347 ↗
• MalfunctionOct 8, 2018Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE TARGET LESION WAS VERY CALCIFIED. A NON-COMPLAINT BALLOON WAS USED FOR PRE-DILATION, THEN A GUIDEZILLA II GUIDE CATHETER WAS PLACED FOR SUPPORT AND A 10 MM X 2.50MM WOLVERINE CUTTING BALLOON WAS ADVANCED, HOWEVER, IT WOULD NOT CROSS THE LESION AND THE SHAFT BROKE. THE DEVICE WAS RETRIEVED. NO PATIENT COMPLICATIONS WERE REPORTED. BASED ON THE POTENTIAL ROOT CAUSES IDENTIFIED, THE FOLLOWING ATTRIBUTES WERE EXAMINED: THE DEVICE WAS RECEIVED IN TWO SECTIONS AS THE RESULT OF A BREAK IN THE HYPOTUBE. A VISUAL AND TACTILE EXAMINATION IDENTIFIED A COMPLETE BREAK IN THE HYPOTUBE OF THE DEVICE. THE BREAK WAS LOCATED AT 230MM DISTAL TO THE STRAIN RELIEF. THE HYPOTUBE WAS ALSO NOTED TO BE SEVERELY KINKED AT SEVERAL LOCATIONS ALONG ITS LENGTH. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. NO ISSUES WERE NOTED WITH THE HYPOTUBE THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. A VISUAL AND TACTILE EXAMINATION IDENTIFIED THAT THE SHAFT POLYMER EXTRUSION WAS KINKED AT MORE THAN ONE LOCATION ALONG IT'S LENGTH. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7945077 ↗

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