Wolverine Coronary Cutting Balloon H74939401103750Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729888291), received between Feb 6, 2019 and Mar 26, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2024Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 10MMX3.75MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE DEVICE ENTERED INTO THE PATIENT, IT WAS NOTED THAT THE MID SHAFT BROKE IN HALF. THE DEVICE WAS COMPLETELY PULLED OUT FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18983880 ↗
• MalfunctionOct 15, 2020Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILD TO MODERATELY TORTUOUS AND SEVERELY CALCIFIED MID RIGHT CORONARY ARTERY. A 10MMX3.75MM WOLVERINE CORONARY CUTTING BALLOON WAS USED POST ABLATION. DURING PROCEDURE, THE BALLOON WAS INFLATED AT 6ATM TWICE, HOWEVER IT COULD NOT INCREASE IN PRESSURE UPON THIRD INFLATION. A VISIBLE HOLE ON THE BALLOON ITSELF WAS NOTED UPON REMOVAL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND PATIENT WAS IN NORMAL CONDITION POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10683298 ↗
• MalfunctionFeb 6, 2019Break; Failure to Advance; Difficult to Advance; Break; Failure to Advance; Difficult to Advance

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED ON A FOCAL, CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY. THE LESION WAS ATTEMPTED TO BE DILATED WITH NC TREK BALLOONS WITH NO SUCCESS. A 10MMX3.75MM WOLVERINE CORONARY CUTTING BALLOON WOULD NOT CROSS THE LESION AND THE SHAFT BROKE. A 10MMX3.50 WOLVERINE CORONARY CUTTING BALLOON WAS THEN ATTEMPTED BUT ALSO WOULD NOT CROSS AND THE SHAFT BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE WITHOUT ISSUE OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8310389 ↗

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