Flextome® Cutting Balloon® H749CBM3250100Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729808336), received between Apr 27, 2017 and Apr 30, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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.

• MalfunctionApr 30, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 10MMX2.50MM FLEXTOME® CUTTING BALLOON® WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT BALLOON RUPTURED AT THE SECOND INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS REPORTED AND PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7473544 ↗
• MalfunctionJul 24, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON PINHOLE OCCURRED. THE TARGET LESION WAS LOCATED AT THE LEFT ANTERIOR DESCENDING ARTERY. A 10/2.50 FLEXTOME® CUTTING BALLOON® WAS SELECTED FOR USE. DURING THE PROCEDURE INSIDE PATIENT'S BODY, BLOOD WAS NOTED WHEN DOING A NEGATIVE PREPARATION BY APPLYING NEGATIVE PRESSURE TO THE DEVICE. THE DEVICE WAS THEN REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF THE CUTTING BALLOON. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6737098 ↗
• MalfunctionJun 21, 2017Break; Break

  IT WAS REPORTED THAT A CATHETER SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 10/2.50 FLEXTOME® CUTTING BALLOON® WAS SELECTED FOR USE. DURING PROCEDURE, THE CATHETER WAS ADVANCED TOWARDS THE TARGET LESION WHEN THE DEVICE BECAME KINKED. THE PHYSICIAN HAD TO KEEP PUSHING THE CATHETER INSIDE THE GUIDE CATHETER, WHICH EVENTUALLY CAUSED THE SHAFT TO BREAK ON THE CUTTING BALLOON. THE FLEXTOME WAS REMOVED TOGETHER WITH THE WIRE AS THE BROKEN COMPONENT WAS STILL INSIDE THE GUIDE CATHETER. 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 6657665 ↗
• MalfunctionApr 27, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL TO LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 10/2.50 FLEXTOME¿ CUTTING BALLOON¿ WAS SELECTED FOR USE. DURING THE PROCEDURE, PHYSICIAN ADVANCED THE DEVICE TO THE DESIRED LESION. THE BALLOON WAS INFLATED, HOWEVER, IT WAS NOTED THAT IT RUPTURED AT 2 ATMOSPHERES. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY USING THE MONORAIL TECHNIQUE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6526919 ↗

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.