Wolverine Coronary Cutting Balloon H74939401063000Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729888178), received between Dec 10, 2019 and Jan 27, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2025Break; Break

  IT WAS REPORTED THAT THE SHAFT BROKE. A 6MMX3.00MM WOLVERINE CUTTING BALLOON MONORAIL WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION. DURING THE PROCEDURE, IT WAS NOTED THAT THE SHAFT BROKE WHILE IN THE MIDDLE OF THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21245817 ↗
• MalfunctionNov 2, 2022Break; Break

  IT WAS REPORTED THAT THE SHAFT SNAPPED OFF. A 6MMX3.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING PREPARATION, THE BALLOON WAS ATTEMPTED TO PUT ON THE GUIDEWIRE TO PUT INTO THE PATIENT ON AN INTERVENTION. HOWEVER, 1/3 OF THE BALLOON SHAFT THAT WOULD BE ATTACHED TO THE INDEFLATOR SNAPPED OFF MIDWAY WITH NO STRESS PLACED ON IT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WOLVERINE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15715418 ↗
• MalfunctionMar 21, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A LABELING ISSUE OCCURRED. WHILE OUTSIDE THE PATIENT, DURING PREPARATION OF A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), A 3.00MM X 6MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR TREATMENT, BUT THE BALLOON INNER PLASTIC PACKAGING WAS NOTICED TO BE MISLABELED. IT WAS NOTED THAT A 3.00MM X 6MM WOLVERINE BALLOON APPEARED ON THE BOX, BUT THE INSIDE PLASTIC PACKAGING WAS NOTICED TO BE A 2.75MM X 6MM WOLVERINE BALLOON. NO DAMAGE TO THE PACKAGE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13840280 ↗
• MalfunctionMar 21, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A LABELING ISSUE OCCURRED. WHILE OUTSIDE THE PATIENT, DURING PREPARATION OF A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), A 3.00MM X 6MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR TREATMENT, BUT THE BALLOON INNER PLASTIC PACKAGING WAS NOTICED TO BE MISLABELED. IT WAS NOTED THAT A 3.00MM X 6MM WOLVERINE BALLOON APPEARED ON THE BOX, BUT THE INSIDE PLASTIC PACKAGING WAS NOTICED TO BE A 2.75MM X 6MM WOLVERINE BALLOON. NO DAMAGE TO THE PACKAGE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13840279 ↗
• MalfunctionMay 10, 2021Difficult to Remove; Failure to Advance; Difficult to Advance; Difficult to Remove; Failure to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO REMOVE. A 6MMX3.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE BALLOON WOULD NOT CROSS THE LESION AND WAS NEVER INFLATED. SUBSEQUENTLY, IT WOULD NOT ENTER THE GUIDE AND WAS DIFFICULT TO REMOVE. THE WOLVERINE CORONARY CUTTING BALLOON WAS FULLY DEFLATED AND WAS REMOVED TOGETHER WITH THE GUIDE CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11801568 ↗
• MalfunctionMar 22, 2021Break; Break

  IT WAS REPORTED THAT THE SHAFT WAS BROKEN. A 6MMX3.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE SHAFT WAS BROKEN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FINE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11546450 ↗
• MalfunctionFeb 16, 2021Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 6MMX3.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING INSERTION, IT WAS NOTED THAT THE SHAFT BROKE OUTSIDE THE PATIENT'S BODY. THERE WAS NO PATIENT INTERACTION AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS DOING WELL POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11334716 ↗
• MalfunctionJun 8, 2020Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT A SHAFT FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED FOCAL LESION OF THE MIDDLE LEFT ANTERIOR DESCENDING ARTERY. A 6MMX3.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, UPON ADVANCEMENT, THE BALLOON SHAFT WAS BENT AND BROKE INTO HALF THROUGH THE GUIDE PRIOR TO GOING INTO THE BODY. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS OKAY POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10130977 ↗
• InjuryDec 10, 2019Failure to Advance; Material Deformation; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS NOTED THAT PATIENT EXPERIENCED VESSEL DISSECTION. THE TARGET LESION WAS LOCATED IN THE CALCIFIED LEFT MAIN PROXIMAL TO LEFT ANTERIOR DESCENDING ARTERY. A 6MMX3.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WAS NOT ABLE TO CROSS AND THE SHAFT WAS BENT APPROXIMATELY 9 INCHES FROM THE HUB. SEVERAL UNSPECIFIED BALLOON DEVICES WERE ALSO USED. THEN, A 6F GUIDEZILLA II WAS ADVANCED USING A 2.5X12MM NC QUANTUM THROUGH THE LEFT MAIN. THE BALLOON WAS THEN REMOVED AND ANOTHER 6MMX3.00MM WOLVERINE CORONARY CUTTING BALLOON WAS ADVANCED WITHOUT DIFFICULTY. HOWEVER, IT WAS NOTED THAT SOME DISSECTION OCCURRED. CONSEQUENTLY, THE DISSECTION WAS STENTED WITH A 3.5X16MM SYNERGY AND BALLOONED WITH 3.25 NC TO POST DILATE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE POST PROCEDURE. IT WAS FURTHER REPORTED THE PATIENT WAS STABLE POST PROCEDURE. IN THE PHYSICIAN OPINION THE CAUSE OF DISSECTION MAY HAVE BEEN DUE TO THE CALCIFIED LESION OR THE INFLATABLE DEVICES.

  Patient problems: Vascular Dissection

  MAUDE report 9446899 ↗

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-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