Flexcel Carotid Shunt 2020-05Recalls & reported problems
Lemaitre Vascular, Inc. · Flexcel Carotid Shunt (8F, 10F, 12F, 14F) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840663101344), received between Jun 14, 2018 and Jun 14, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult To Position” (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
- Difficult To Position1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 14, 2018Difficult To Position; Difficult To Position
DURING CAROTID ENDARTERECTOMY, FLEXCEL CAROTID SHUNT WAS USED AS A BLOOD CONDUIT TO ALLOW BLOOD FLOW BETWEEN THE COMMON AND INTERNAL CAROTID ARTERY. SURGEON EXPERIENCED DIFFICULTY WHEN POSITIONING THE SHUNT IN THE PATIENT'S ARTERY AS IT WAS MOVING IN THE LUMEN. AS A RESULT, THE TIP OF THE SHUNT DISSECTED A SECTION OF THE INTERNAL CAROTID ARTERY. SURGEON USED A PATCH TO REPAIR THE DISSECTED SECTION AFTER EXTENDING THE ARTERIOTOMY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7603513 ↗
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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