Flextome® Cutting Balloon® H749CBM3400100Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729808398), received between Apr 5, 2017 and Sep 13, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2018Break; Break

  IT WAS REPORTED THAT THE BALLOON BROKE. A 10/4.00 FLEXTOME CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BROKE AND THE WIRE CAME OUT FROM THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7874642 ↗
• MalfunctionSep 25, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE OSTIAL RIGHT CORONARY ARTERY. A 4.00MM X 10MM FLEXTOME CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, THE DEVICE WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE BALLOON RUPTURED WHEN INFLATION WAS ATTEMPTED. THE DEVICE WAS COMPLETELY REMOVED 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 6892621 ↗
• MalfunctionMay 17, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE OSTIAL RIGHT CORONARY ARTERY (RCA). A 10 X 4.00 FLEXTOME¿ CUTTING BALLOON¿ WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED. THE SCRUB TECH WENT INTO THE GUIDE AND PULLED NEGATIVE ON IT BUT BLOOD CAME UP TO THE LUMEN. IT WAS IN THE BODY BEFORE IT EVEN REACH THE ARTERY. A STIFFNESS WAS OBSERVED WHEN DEVICE WAS IN THE GUIDE CATHETER. PHYSICIAN PULLED THE DEVICE BUT IT PULLED BLOOD. THERE WAS A HOLE IN IT AND IT WAS SEEN THAT A CONTRAST CAME OUT FROM IT. ALTHOUGH, IT WAS UNSURE IF RUPTURE OCCURRED WHEN IT CAME THROUGH OR DURING PREPARATION, BUT THE EVENT WAS NOTICED DURING PREPARATION AND ALSO DURING ADVANCING THE DEVICE IN THE BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS WAS WONDERFUL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6573069 ↗
• MalfunctionApr 5, 2017Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A 4.00 X 10 MM FLEXTOME® CUTTING BALLOON® WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE DEVICE WAS INSERTED INTO THE TIP OF THE GUIDE CATHETER, IT WAS NOTED THAT THE BALLOON CATHETER BROKE. ANOTHER 4.00 X 10 MM FLEXTOME® CUTTING BALLOON® WAS USED, HOWEVER IT WAS KINKED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6461579 ↗

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.