Flextome® Cutting Balloon® H749CBO3400100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729808664), received between Dec 15, 2017 and Dec 19, 2017 — classified as 1 injury, 1 malfunction.

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

• MalfunctionDec 19, 2017Defective Component; Defective Component

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06-DEC-2017. IT WAS REPORTED THAT THE ATHERETOMES WERE NOT THE SAME LENGTH OR DEPTH. A 10/4.00 FLEXTOME® CUTTING BALLOON® WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION. DURING PREPARATION, OUTSIDE PATIENT'S BODY, IT WAS NOTED THAT THE ATHERETOMES WERE NOT THE SAME LENGTH/DEPTH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT ONE OF THE BLADES WAS COMPLETELY DETACHED FROM THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7130228 ↗
• InjuryDec 15, 2017Detachment Of Device Component; Deflation Problem; Difficult to Remove; Detachment Of Device Component; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THE DEVICE WAS DIFFICULT TO REMOVE AND AN EMBOLISM OCCURRED. A FLEXTOME CUTTING BALLOON WAS BEING USED IN THE PULMONARY VEIN. AFTER INFLATION, THE BALLOON WAS UNABLE TO BE PULLED BACK INTO THE DELIVERY SHEATH AND BLADES LIFTED. IT WAS UNKNOWN IF THE BALLOON REWRAPPED PROPERLY OR IF THE BALLOON WAS UNABLE TO DEFLATE COMPLETELY. THE DEVICE WAS REMOVED FROM THE PATIENT ALONG WITH THE GUIDE CATHETER SYSTEM IN TANDEM . THE PROCEDURE WAS COMPLETED. IT WAS FURTHER REPORTED A THROMBOTIC EVENT OCCURRED. THIS WAS PERCEIVED TO HAVE BEEN CAUSED BY THE EQUIPMENT BEING STAGNANT WITHIN VESSEL THE PATIENT WAS REPORTED TO BE FINE POST PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN ABLE TO BE OBTAINED.

  Patient problems: Embolism

  MAUDE report 7122789 ↗

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.