Flextome® Cutting Balloon® H749CBM3400150Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729808480), received between Jan 5, 2017 and Jun 10, 2019 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON LEAK OCCURRED. A 15/4.00 FLEXTOME CUTTING BALLOON WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE BALLOON LEAKED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8684685 ↗
• MalfunctionApr 12, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A 15/4.00 FLEXTOME® CUTTING BALLOON® WAS SELECTED FOR USE FOR THE PERCUTANEOUS CORONARY INTERVENTION FOR IN-STENT RESTENOSIS TO OSTIAL RCA. DURING PREPARATION, IT WAS NOTED THAT THE BALLOON BROKE FROM THE SHAFT. THE DEVICE DID NOT ENTER THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7425063 ↗
• MalfunctionApr 2, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. A 4.0 X 15 FLEXTOME® CUTTING BALLOON® WAS SELECTED FOR USE. DURING PREPARATION, OUTSIDE PATIENT'S BODY, THE BALLOON CAME OFF WITH BLUE SHEATH COVERING THE BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7389310 ↗
• MalfunctionApr 2, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. A 4.0 X 15 FLEXTOME CUTTING BALLOON WAS SELECTED FOR USE. DURING PREPARATION, OUTSIDE PATIENT'S BODY, THE BALLOON CAME OFF WITH BLUE SHEATH COVERING THE BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7389309 ↗
• MalfunctionOct 2, 2017Break; Break

  IT WAS REPORTED THAT THE BALLOON SEPARATED FROM THE CATHETER. THE TARGET LESION WAS LOCATED IN THE CAROTID ARTERY. A 4.00MM X 15MM FLEXTOME® CUTTING BALLOON® WAS SELECTED FOR USE. DURING CATHETER PREPARATION, IT WAS NOTED THAT THE CUTTING BALLOON BROKE APART. THE DEVICE DID NOT ENTER THE PATIENT'S BODY. THE PROCEDURE WAS THEN COMPLETED WITH ANOTHER OF THE SAME FLEXTOME® CUTTING BALLOON®. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6907077 ↗
• MalfunctionMay 31, 2017Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT COMMON FEMORAL ARTERY. A 15MM X4MM FLEXTOME® CUTTING BALLOON® WAS SELECTED FOR USE. DURING PREPARATION, WHEN DEVICE WAS OPENED AND AS IT WAS TAKEN OUT OF THE HOOP, IT WAS NOTED THAT THE SHAFT OF THE CATHETER CAME APART OUTSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A 10MM X 4MM FLEXTOME® CUTTING BALLOON®. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6601009 ↗
• MalfunctionJan 5, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED CORONARY ARTERY. A 15/4.00 FLEXTOME® CUTTING BALLOON® WAS SELECTED FOR USE. DURING PROCEDURE, UPON ACHIEVING THE NOMINAL PRESSURE, THE BALLOON RUPTURED AT 6 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6224681 ↗

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-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-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-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