ASCENT BRS000609-00Recalls & reported problems
Medos International Sàrl · ASCENT balloon catheter Occlusion Balloon Catheter 6mm x 9mm 150 cm 3 cm 3 mm 2.9 F (0.98 mm) 0.0170 Inch (0.43 mm) Contents: 1 ASCENT Occlusion Balloon Catheter · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878528001935), received between Nov 21, 2017 and Jun 12, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Crack” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Crack1
- Split1
- Torn Material1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2018Torn Material; Torn Material
THE HEALTHCARE PROFESSIONAL REPORTED THAT THE ASCENT REMODEL BALLOON CATHETER 6 X 9 (BRS00060900 / LOT NUMBER NOT AVAILABLE) BECAME KINKED DURING THE PROCEDURE. THE PHYSICIAN REPLACED THE BALLOON CATHETER AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7592951 ↗MalfunctionNov 21, 2017Crack; Split; Crack; Split
IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A CES BALLOON CATHETER (BRS00060900/C42351) WAS USED DURING A PROCEDURE, HOWEVER, THE CATHETER WAS NOT FLUSHED BECAUSE IT COULD NOT BE PUMPED. THE PHYSICIAN USED A SIMILAR PRODUCT TO SUCCESSFULLY COMPLETE THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7050732 ↗
Other Catheter, intravascular occluding, temporary devices
- Pruitt F3 Carotid Shunt 2012-10Lemaitre Vascular, Inc. · Catheter, Intravascular Occluding, Temporary1 death158 reports
- GORE Molding Occlusion Balloon Catheter MOB37W. L. Gore & Associates, Inc. · Catheter, Intravascular Occluding, Temporary6 deaths152 reports
- Bridge Occlusion Balloon 590-001Spectranetics Corporation · Catheter, Intravascular Occluding, Temporary4 deaths57 reports
- Pruitt F3 Carotid Shunt e2012-10Lemaitre Vascular, Inc. · Catheter, Intravascular Occluding, Temporary53 reports
- Pruitt F3 Carotid Shunt 2013-10Lemaitre Vascular, Inc. · Catheter, Intravascular Occluding, Temporary46 reports
- Equalizer™ M001171100Boston Scientific Corporation · Catheter, intravascular occluding, temporary18 reports
- Pruitt F3 Carotid Shunt e2013-10Lemaitre Vascular, Inc. · Catheter, Intravascular Occluding, Temporary17 reports
- TRANSFORM M003SSC07070Stryker Corporation · Catheter, intravascular occluding, temporary17 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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.
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