Flextome® Cutting Balloon® H749CBM3300100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729808350), received between Aug 23, 2017 and Feb 22, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionFeb 22, 2018Break; Break

  IT WAS REPORTED THAT A CATHETER SHAFT BREAK OCCURRED. A 10/3.00 FLEXTOME CUTTING BALLOON WAS SELECTED FOR USE. DURING PREPARATION, WHEN THEY PULLED THE FLEXTOME BALLOON OUT OF THE HOOP TO PRESS IT, IT WAS NOTED THAT THERE WAS A KINK IN THE SHAFT ABOUT 4-6 INCHES FROM THE HUB. THE DEVICE WAS NOT USED INTO THE PATIENT'S BODY. WHEN THE BALLOON WAS PUT BACK IN THE HOOP, IT WAS FURTHER NOTED THAT THE SHAFT COMPLETELY BROKE IN TWO. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7289574 ↗
• MalfunctionAug 23, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DETACHMENT OCCURRED. A 10 MM X 3.00 MM FLEXTOME® CUTTING BALLOON® WAS SELECTED FOR USE. DURING UNPACKING, IT WAS NOTED THAT THE STYLET WAS SEPARATED FROM THE CUTTING BALLOON. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6814974 ↗

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.