Flextome® Cutting Balloon® H749CBM3300060Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729808268), received between Feb 22, 2017 and Sep 4, 2018 — classified as 1 injury, 1 malfunction.

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.

• InjurySep 4, 2018Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A BALLOON LODGED IN PATIENT'S ARTERY AND PATIENT COMPLICATIONS OCCURRED. A 06/3.00 FLEXTOME CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BECAME LODGED IN THE PATIENT'S LEFT MAIN ARTERY. THE PATIENT HAD VERY HEAVY CALCIUM IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) TO LEFT MAIN (LM). THESE VESSELS WERE NOT STENTED; HOWEVER, THE CIRCUMFLEX WAS STENTED TO THE BIFURCATION. THE PATIENT WAS CODED ON THE TABLE AND AN IMPELLA WAS PLACED TO HELP STABILIZE THE PATIENT. THE PATIENT WAS RUSHED TO OPEN HEART SURGERY AND DOES NOT HAVE A GOOD CHANCE OF SURVIVING.

  Patient problems: Cardiopulmonary Arrest; No Code Available

  MAUDE report 7842621 ↗
• MalfunctionFeb 22, 2017Break; Break

  IT WAS REPORTED THAT CATHETER SHAFT BREAK OCCURRED. A 06/3.00 FLEXTOME® CUTTING BALLOON® WAS SELECTED FOR USE. DURING PREPARATION AFTER THE STYLET WAS TAKEN OUT, IT WAS NOTED THAT THE END OF CATHETER SHAFT BROKE OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6349892 ↗

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.