Flextome® Cutting Balloon® H749CBO3300100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729808626), received between Nov 9, 2017 and Dec 19, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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, 2017Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BALLOON WOULD NOT RETRACT BACK INTO THE DELIVERY SHEATH AND THE BLADE WAS PARTIALLY LIFTED. THE TARGET LESION WAS LOCATED IN THE PULMONARY VEIN. A 10/3.00 FLEXTOME® CUTTING BALLOON® CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE BALLOON WOULD NOT RETRACT BACK INTO THE DELIVERY SHEATH AND THE BLADE APPEARED TO BE BENT AND PARTIALLY PULLED AWAY FROM THE BALLOON. THE WHOLE SYSTEM WAS THEN PULLED OUT FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7128103 ↗
• MalfunctionNov 9, 2017Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTY OCCURRED. A 3.00MM X 10MM FLEXTOME® CUTTING BALLOON® WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE BALLOON HAD DIFFICULTY DEFLATING. FURTHERMORE, IT WAS NOTED THAT THE BALLOON WOULD NOT RE-FOLD AFTER DEFLATION. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7014080 ↗

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