Wolverine Coronary Cutting Balloon H74939401152000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729888314), received between Mar 4, 2019 and Aug 21, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2020Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED AND THE PATIENT WAS SENT FOR SURGERY. THE 85% STENOSED, ECCENTRIC, TYPE 1 TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED FIRST DIAGONAL ARTERY. A 15MMX2.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WAS UNABLE TO CROSS THE LESION. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS SENT FOR SURGERY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 10436967 ↗
• MalfunctionMar 4, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A PINHOLE WAS PRESENT. DURING PREPARATION OF A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY, A PINHOLE WAS NOTICED BY THE PHYSICIAN IN THE 15MM X 2.00MM WOLVERINE CORONARY CUTTING BALLOON. DUE TO THE PINHOLE, THE BALLOON WAS NOT ABLE TO BE PREPARED AND WAS NOT USED. A SECOND OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER ISSUES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8388531 ↗

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