Wolverine Coronary Cutting Balloon H74939401104000Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 08714729888307), received between Mar 21, 2018 and Aug 14, 2026 — classified as 4 injuries, 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Device-Device Incompatibility; Device Dislodged or Dislocated

  It was reported that the blades were opened.The target lesion was located in the coronary artery. A 10mmX4.00mm Wolverine Coronary Cutting Balloon was selected for use. During preparation, at removal from the package, the physician observed that the blades appeared winged/opened. During use, the balloon was unable to cross through the 6F guide catheter. The procedure was completed with another of the same device. There were no patient complications, and the patient was in good condition after the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50245618 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VESSEL PERFORATION OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. MULTIPLE INFLATIONS WITH A NON-BOSTON SCIENTIFIC LITHOTRIPSY BALLOON WERE USED TO SIZE THE LESION AT 4.00 MM. AN OPTICROSS 6 HD IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. THE 10 MM X 4.00 MM WOLVERINE CORONARY CUTTING BALLOON MONORAIL WAS THEN INTRODUCED AND DURING THE SECOND INFLATION OF THE BALLOON, A VESSEL PERFORATION WAS NOTED. THE PATIENT BLOOD PRESSURE DROPPED WITH NO ASSOCIATED PAIN AT THE TIME OF THE PERFORATION. ANOTHER BALLOON WAS TEMPORARILY USED TO COVER THE PERFORATION, AND A COVERED STENT WAS SUBSEQUENTLY DEPLOYED TO SEAL IT. IVUS IMAGING WAS THEN PERFORMED TO CONFIRM THAT THE STENT COMPLETELY COVERED THE PERFORATION. THERE WERE NO FURTHER COMPLICATIONS. THE PATIENT RECOVERED AND WAS DISCHARGED THREE DAYS LATER.

  Patient problems: Low Blood Pressure/ Hypotension; Perforation

  MAUDE report 24508294 ↗
• InjuryFeb 20, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BALLOON GOT STUCK AND WAS DETACHED REQUIRING INTERVENTION TO REMOVE. THE TARGET LESION WAS LOCATED IN A PERIPHERAL VASCULAR FISTULA. A 10MMX4.00MM WOLVERINE CUTTING BALLOON WAS SELECTED FOR USE. DURING WITHDRAWAL, UPON ATTEMPT TO PULL WOLVERINE BACK INTO THE GUIDE SHEATH, THE DEVICE BECAME STUCK AT END OF SHEATH. THE BALLOON WAS FORCEFULLY PULLED BACK AND UPON EXITING, THE SHEATH WAS NOTED TO HAVE LOST ONE OF THE BLADES. CONSEQUENTLY, AN ULTRASOUND GUIDED CUTDOWN PROCEDURE WAS PERFORMED TO REMOVE THE DETACHED LOST BLADE. THE PROCEDURE WAS COMPLETED USING THIS DEVICE. THE PATIENT UNDERWENT SURGERY AND FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21428471 ↗
• MalfunctionOct 4, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 10MMX4.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST AT RATED BURST PRESSURE. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17871000 ↗
• MalfunctionJun 21, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE BALLOON WAS DIFFICULT TO REMOVE FROM THE LESION. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SAPHENOUS VEIN GRAFT. A 10MMX4.00MM WOLVERINE CORONARY CUTTING BALLOON WAS INFLATED TO THE RATED BURST OF 12ATM. DURING THE PROCEDURE, UPON REMOVAL, IT WAS NOTED, THAT THE BALLOON SEEMED STUCK AND WAS DIFFICULT TO REMOVE. A SLOW DEFLATION AND A NEGATIVE PRESSURE WERE APPLIED. AND EVENTUALLY, THE DEVICE WAS REMOVED COMPLETELY FROM THE PATIENT. THE DEVICE WAS OBSERVED TO BE BULKY AND PARTIALLY DEFLATED. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17174924 ↗
• MalfunctionMay 24, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED NODULAR MORPOLOGY DISTAL RIGHT CORONARY ARTERY. A 10MMX4.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON WAS INFLATED THRICE WITHIN 5-10 SECONDS AFTER SECOND INFLATION. HOWEVER, AT THIRD INFLATION, IT WAS NOTED THAT THE BALLOON RUPTURED AT 6ATM. THE DEVICE WAS REMOVED FROM THE PATIENT EASILY THROUGH THE GUIDE CATHETER OVER THE WIRE. THE PROCEDURE WAS COMPLETED WITH THE DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16990240 ↗
• MalfunctionMar 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. A 10MMX4.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON HAD A HOLE IN IT UPON INITIAL INFLATION AND A BALLOON LEAK WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER WOLVERINE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16485366 ↗
• MalfunctionOct 20, 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. A 10MMX4.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED BALLOON SHAFT HAS BROKEN OFF WHILE INSERTING. 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 15641173 ↗
• MalfunctionOct 6, 2021Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SHAFT LEAK OCCURRED. A 10MMX4.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING PREPARATION, THE BALLOON APPEARED DAMAGED WHEN IT WAS REMOVED FROM THE PACKAGING. THERE WERE NO OBVIOUS HOLES IN THE BALLOON. THE DISTAL END LOOKED SLIGHTLY DEFORMED. SHAFT APPEARED TO BE INTACT. THE BALLOON WAS TESTED OUTSIDE THE PATIENT AND IT WAS NOTED TO BE LEAKING. THE PROCEDURE WAS COMPLETED USING ANOTHER 10MMX4.00MM WOLVERINE CORONARY CUTTING BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12583607 ↗
• InjurySep 23, 2021Break; Difficult to Remove; Detachment of Device or Device Component; Break; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BALLOON WAS STUCK IN LESION, THE TIP BROKE OFF AND WAS REMAINED INSIDE THE PATIENT. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED MID CORONARY ARTERY. A 10MMX4.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON WAS INFLATED UP TO 10 ATMOSPHERES AND THE BLADES WERE DEPLOYED IN THE LESION. UPON REMOVAL, THE BALLOON WAS FULLY DEFLATED AND IT WAS NOTED THAT THE DEVICE WAS STUCK IN LESION. THE PHYSICIAN ATTEMPTED TO RETRACT THE BALLOON WITH GREAT FORCE AT WHICH POINT THE TIP BROKE OFF. THE DEVICE WAS NOT ABLE TO BE RETRIEVED AFTER SEVERAL ATTEMPTS. THE PROCEDURE WAS COMPLETED BY STENTING THE DEVICE AND LEFT IT INSIDE THE BODY. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE DISTAL PORTION OF THE DEVICE INCLUDING BALLOON/BLADES BROKE OFF. THE BALLOON WAS FULLY DEFLATED BEFORE ATTEMPTING TO PULL THE DEVICE BACK INTO THE GUIDECATHER.

  Patient problems: Foreign Body In Patient

  MAUDE report 12522532 ↗
• MalfunctionMay 20, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE SHAFT BROKE. A 10MMX4.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE SHAFT BROKE IN THE GUIDE AFTER GETTING KINKED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS SIMPLY PULLED OUT AND NO FRAGMENTS WERE LEFT IN THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11860930 ↗
• MalfunctionMay 19, 2021Break; Break

  IT WAS REPORTED THAT THE SHAFT WAS BROKEN. A 10MMX4.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. UPON UNPACKING, IT WAS NOTED THAT THE SHAFT WAS BROKEN. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11852104 ↗
• InjuryNov 12, 2020Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BALLOON BURST AND BLADE DETACHED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED. THE 4.0X12 TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED COMPLEX PROXIMAL RIGHT CORONARY ARTERY. A 10MMX4.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, THE BALLOON GOT STUCK AND BURST UPON SECOND INFLATION AT 12ATM FOR 10 SECONDS. THE DEVICE WAS TRIED TO PULLED OUT, RE-INFLATED AND BALLOONED ON BUDDY WIRE. THE DEVICE WAS THEN TRAPPED IN A GUIDELINER AND SNARED OUT. IT WAS ALSO NOTED THAT THE BLADE CAME IN CONTACT WITH PLAQUE JUST PROXIMAL TO STENT AND DETACHED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 10830628 ↗
• MalfunctionJun 22, 2020Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE WIRE PROTRUDED FROM THE BALLOON. A 10MMX4.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE WIRE WAS PROTRUDING FROM THE BALLOON AFTER INSERTION. A NEW WOLVERINE WAS THEN USED AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10180885 ↗
• MalfunctionFeb 22, 2019Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED. THE SHAFT OF A 10MMX4.00MM WOLVERINE CORONARY CUTTING BALLOON WAS REPORTED TO HAVE BROKE DURING ADVANCEMENT OVER A .014 GUIDEWIRE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ISSUE OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8362668 ↗
• MalfunctionDec 14, 2018Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 10MMX4.00MM WOLVERINE CORONARY CUTTING BALLOON SHAFT BROKE IN HALF DURING PREPARATION, OUTSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8164895 ↗
• MalfunctionOct 3, 2018Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT A BREAK IN A HYPOTUBE OCCURRED. THE TARGET LESION WAS THE SAPHENOUS VEIN GRAFT TO OBTUSE MARGIN. A WHILE ADVANCING A 10 MM X 4.0 MM WOLVERINE CORONARY CUTTING BALLOON WITHIN A CONVEY GUIDE CATHETER, THE WOLVERINE SHAFT KINKED AND THEN BROKE IN HALF. THE DEVICE WAS RETRIEVED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7931908 ↗
• MalfunctionJul 5, 2018Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. AS THE 10MMX4.00MM WOLVERINE CORONARY CUTTING BALLOON MONORAIL WAS BEING INTRODUCED, THE DEVICE CAME APART WITH THE INFLATION LUMEN SECTION SEPARATING AT THE MONORAIL SECTION. THE DEVICE WAS REMOVED BY PULLING BACK THE GUIDE AND THE PROCEDURE COMPLETED WITH A DIFFERENT DEVICE NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7664311 ↗
• MalfunctionMar 21, 2018Detachment Of Device Component; Detachment Of Device Component

  REPORTABLE BASED ON ANALYSIS COMPLETED (B)(6) 2018. IT WAS REPORTED THAT BLADE DETACHMENT OCCURRED POST PROCEDURE DURING MANIPULATION OF THE DEVICE. THE CHRONIC TOTAL OCCLUDED TARGET LESION WAS MODERATELY TORTUOUS, CALCIFIED AND >20 MM IN LENGTH. A 10MM X 4.00MM WOLVERINE¿ CORONARY CUTTING BALLOON® MONORAIL® WAS INFLATED THREE TIMES BETWEEN NOMINAL AND RATED PRESSURE FOR 10-15 SECONDS EACH. THE CUTTING BALLOON PERFORMED WELL IN THE CASE. THE BLADES WERE COMPLETELY SECURE TO THE BALLOON IMMEDIATELY POST PROCEDURE. THERE WERE NO PATIENT COMPILATIONS. AFTER THE PROCEDURE, A FELLOW WAS PLAYING WITH THE DEVICE ON THE BACK TABLE WHEN ONE BLADE FELL OFF AND ANOTHER BLADE PARTIALLY DETACHED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A PINHOLE IN THE BALLOON MATERIAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7359117 ↗

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.