Pruitt F3 Carotid Shunt e2012-12Recalls & reported problems
Lemaitre Vascular, Inc. · 9F Pruitt F3 Inlying Shunt with T-port, eIFU · Class 2
All models of Pruitt F3 Carotid Shunt (10)
Data updated Oct 18, 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 00840663101306), received between Nov 2, 2022 and Nov 2, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
1 other recall cover devices cleared under the same FDA submission (K051067); 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 2, 2023Material Rupture; Material Rupture
IT WAS REPORTED THE PRUITT F3 CAROTID SHUNT BALLOON DID NOT DEFLATE WHEN ATTEMPTING TO REMOVE FROM PATIENT'S CAROTID ARTERY. IT WAS REMOVED FULLY INFLATED DESPITE MULTIPLE ATTEMPTS TO DEFLATE. THE SHUNT WAS INSPECTED AFTER AND A HOLE WAS FOUND IN THE TUBING. NO INJURY WAS REPORTED TO THE PATIENT. THE CUSTOMER ELECTED NOT PROVIDE SITE CONTACT INFORMATION. THEREFORE, WE'RE UNABLE TO GET THE DEVICE RETURNED OR PROVIDE A CORRESPONDENCE LETTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18055205 ↗MalfunctionNov 2, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE PRUITT F3 CAROTID SHUNT HAD A LEAKING SAFETY BALLOON DUE TO A TINY HOLE. THE INCIDENT OCCURRED DURING SHUNT REPLACEMENT WHILE PERFORMING A LEFT SIDED CAROTID ENDARTERECTOMY. THE SHUNT WAS REPLACED WITH A DIFFERENT ONE. NO HARM TO PATIENT WAS DOCUMENTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15714066 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K051067. One submission often covers many models, so check the product and lot details in each record.
- Z-0070-2012 · Oct 4, 2011 · TerminatedLeMaitre 9F Pruitt F3 Outlying Carotid Shunt with T-port The Pruitt F3 Carotid Shunt (the Shunt) is a multi-lumen device with balloons at both the distal (internal carotid) and pr
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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