Occlusion Balloon Catheter M001171020Recalls & reported problems
Boston Scientific Corporation · Occlusion Balloon Catheter · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729112389), received between Dec 9, 2016 and Dec 9, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Damaged Prior to Use” (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 18, 2026.
Most reported problems
Device problems
- Device Damaged Prior to Use1
- Leak/Splash1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 9, 2016Leak/Splash; Device Damaged Prior to Use; Leak/Splash; Device Damaged Prior to Use
REPORTABLE BASED ON ANALYSIS COMPLETED ON 24NOV2016. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. A 7/2/65 OCCLUSION BALLOON CATHETER WAS SELECTED FOR USE. DURING PREPARATION, WHEN THE PHYSICIAN FLUSHED THE WIRE PORT AND PRE-TESTED THE BALLOON WITH SALINE SYRINGE, A LEAK WAS NOTED FROM THE BALLOON. THE DEVICE DID NOT ENTER THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.
Patient problems: No Patient Involvement
MAUDE report 6162617 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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