Flextome Cutting BalloonRecalls & reported problems across all models
Boston Scientific Corporation · 15 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 34
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 15 models of Flextome Cutting Balloon by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 34 adverse event reports in the FDA's MAUDE database, received between Dec 5, 2016 and Dec 12, 2019 — classified as 4 injuries, 30 malfunctions.
The most frequently reported specific device problem is “Break” (11 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported Flextome Cutting Balloon problems
Device problems
- Break11
- Material Rupture10
- Detachment Of Device Component6
- Deflation Problem2
- Defective Component1
- Detachment of Device or Device Component1
- Device Markings/Labelling Problem1
- Difficult to Remove1
Patient problems
- No Consequences Or Impact To Patient22
- No Patient Involvement8
- Injury2
- Cardiopulmonary Arrest1
- Embolism1
- No Code Available1
Flextome Cutting Balloon models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Flextome® Cutting Balloon® H749CBM3400150Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring7 reports
- Flextome® Cutting Balloon® H749CBM3250100Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring4 reports
- Flextome® Cutting Balloon® H749CBM3400100Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring4 reports
- Flextome® Cutting Balloon® H749CBM3300060Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring2 reports
- Flextome® Cutting Balloon® H749CBM3200100Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring2 reports
- Flextome® Cutting Balloon® H749CBM3300100Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring2 reports
- Flextome® Cutting Balloon® H749CBM3350100Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring2 reports
- Flextome® Cutting Balloon® H749CBM3375100Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring2 reports
- Flextome® Cutting Balloon® H749CBO3300100Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring2 reports
- Flextome® Cutting Balloon® H749CBO3400100Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring2 reports
- Flextome® Cutting Balloon® H749CBM3200060Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring1 report
- Flextome® Cutting Balloon® H749CBM3375060Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring1 report
- Flextome® Cutting Balloon® H749CBM3400060Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring1 report
- Flextome® Cutting Balloon® H749CBM3250150Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring1 report
- Flextome® Cutting Balloon® H749CBO3400150Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring1 report
Recent Flextome Cutting Balloon adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 12, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 06/4.00 FLEXTOME CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED AND A 3.5X10 WOLVERINE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9460886 ↗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 ↗MalfunctionDec 20, 2018Material Rupture; Material Rupture
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 15*2.50 FLEXTOME CUTTING BALLOON WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED AT 6ATM. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8187413 ↗MalfunctionSep 24, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT A LABELING ISSUE OCCURRED. A 10/3.75 FLEXTOME CUTTING BALLOON WAS SELECTED FOR USE. DURING PREPARATION, IT WAS OBSERVED THAT THE LABEL OUTSIDE OF THE PACKAGING WAS 10X3.75; HOWEVER, THE ACTUAL DEVICE SIZE WAS 10X2.75. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7902916 ↗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 ↗InjurySep 4, 2018Entrapment of Device; Entrapment of Device
IT WAS REPORTED THAT A BALLOON LODGED IN PATIENT'S ARTERY AND PATIENT COMPLICATIONS OCCURRED. A 06/3.00 FLEXTOME CUTTING BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BECAME LODGED IN THE PATIENT'S LEFT MAIN ARTERY. THE PATIENT HAD VERY HEAVY CALCIUM IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) TO LEFT MAIN (LM). THESE VESSELS WERE NOT STENTED; HOWEVER, THE CIRCUMFLEX WAS STENTED TO THE BIFURCATION. THE PATIENT WAS CODED ON THE TABLE AND AN IMPELLA WAS PLACED TO HELP STABILIZE THE PATIENT. THE PATIENT WAS RUSHED TO OPEN HEART SURGERY AND DOES NOT HAVE A GOOD CHANCE OF SURVIVING.
Patient problems: Cardiopulmonary Arrest; No Code Available
MAUDE report 7842621 ↗MalfunctionMay 30, 2018Break; Break
IT WAS REPORTED THAT THE BALLOON CATHETER BROKE. A 10/3.50 FLEXTOME® CUTTING BALLOON® WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE BROKE INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7554564 ↗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 ↗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 ↗MalfunctionMar 26, 2018Material Rupture; Material Rupture
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 10MM X 3.50MM FLEXTOME® CUTTING BALLOON® WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED AT 4 ATMS DURING INFLATION. THE DEVICE WAS REMOVED OVER THE GUIDEWIRE AND BALLOON WAS FULLY INTACT. NO PATIENT WERE COMPLICATIONS REPORTED AND PATIENT'S STATUS WAS FINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7370728 ↗MalfunctionFeb 22, 2018Break; Break
IT WAS REPORTED THAT A CATHETER SHAFT BREAK OCCURRED. A 10/3.00 FLEXTOME CUTTING BALLOON WAS SELECTED FOR USE. DURING PREPARATION, WHEN THEY PULLED THE FLEXTOME BALLOON OUT OF THE HOOP TO PRESS IT, IT WAS NOTED THAT THERE WAS A KINK IN THE SHAFT ABOUT 4-6 INCHES FROM THE HUB. THE DEVICE WAS NOT USED INTO THE PATIENT'S BODY. WHEN THE BALLOON WAS PUT BACK IN THE HOOP, IT WAS FURTHER NOTED THAT THE SHAFT COMPLETELY BROKE IN TWO. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Patient Involvement
MAUDE report 7289574 ↗MalfunctionFeb 1, 2018Break; Break
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 10MM X 2MM FLEXTOME® CUTTING BALLOON® WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON FAILED TO CROSS THE TARGET LESION. WHEN BALLOON WAS REMOVED, IT BECAME SNAGGED ON THE TIP OF THE GUIDE CATHETER AND THE SHAFT BECAME SEPARATED. THE WHOLE SYSTEM WAS REMOVED BY PULLING OUT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS FINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7234324 ↗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 ↗
Other Boston Scientific Corporation products
- INGEVITY MRI7 models · 16,601 reports
- INGEVITY+3 models · 16,054 reports
- EMBLEM S-ICD4 models · 13,295 reports · 1 recall
- WATCHMAN25 models · 8,024 reports · 6 recalls
- AMS 800 Artificial Urinary Sphincter31 models · 7,515 reports · 2 recalls
- ENDOTAK RELIANCE SG9 models · 6,540 reports · 2 recalls
- RELIANCE 4-FRONT11 models · 5,739 reports
- FINELINE II EZ Sterox6 models · 5,633 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page