Pruitt F3 Carotid ShuntRecalls & reported problems across all models
Lemaitre Vascular, Inc. · 10 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 305
- Deaths reported
- 1
- Injuries reported
- 21
- Recalls
- 0
We found 10 models of Pruitt F3 Carotid Shunt by Lemaitre Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 305 adverse event reports in the FDA's MAUDE database, received between Nov 25, 2015 and Sep 29, 2026 — classified as 1 death, 21 injuries, 283 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (74 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
Reports received per month, all models
Most reported Pruitt F3 Carotid Shunt problems
Device problems
- Inflation Problem74
- Fluid/Blood Leak51
- Leak/Splash41
- Material Rupture33
- Failure to Deflate28
- Deflation Problem21
- Material Puncture/Hole20
- Thickening of Material8
Patient problems
- No Clinical Signs, Symptoms or Conditions208
- No Known Impact Or Consequence To Patient50
- No Consequences Or Impact To Patient12
- No Patient Involvement11
- Insufficient Information7
- Hemorrhage/Blood Loss/Bleeding5
- No Information5
- Blood Loss4
Pruitt F3 Carotid Shunt models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Pruitt F3 Carotid Shunt 2012-10Catheter, Intravascular Occluding, Temporary1 death158 reports
- Pruitt F3 Carotid Shunt e2012-10Catheter, Intravascular Occluding, Temporary53 reports
- Pruitt F3 Carotid Shunt 2013-10Catheter, Intravascular Occluding, Temporary46 reports
- Pruitt F3 Carotid Shunt e2013-10Catheter, Intravascular Occluding, Temporary17 reports
- Pruitt F3 Carotid Shunt 2012-12Catheter, Intravascular Occluding, Temporary11 reports
- Pruitt F3 Carotid Shunt e2012-11Catheter, Intravascular Occluding, Temporary10 reports
- Pruitt F3 Carotid Shunt 2011-10Catheter, Intravascular Occluding, Temporary5 reports
- Pruitt F3 Carotid Shunt 2012-13Catheter, Intravascular Occluding, Temporary2 reports
- Pruitt F3 Carotid Shunt e2012-12Catheter, Intravascular Occluding, Temporary2 reports
- Pruitt F3 Carotid Shunt e2011-10Catheter, Intravascular Occluding, Temporary1 report
Recent Pruitt F3 Carotid Shunt adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Leak/Splash; Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936609 ↗MalfunctionSep 29, 2026Material Rupture; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935304 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem; Sharp Edges
It was reported approximately four (4) years ago that the customer experienced an incident in which, during removal of a shunt, the device reportedly sliced/cut the patient's artery. The event was not reported at the time of occurrence, and the device was subsequently discarded and is therefore unavailable for investigation.The physician repaired the affected artery, and no further consequences or injury to the patient were reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859112 ↗MalfunctionSep 22, 2026Leak/Splash; Material Puncture/Hole
It was reported that the white balloon was leaking during a pre-use check. The device was not used on a patient. No patient injury was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857457 ↗MalfunctionSep 21, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50844612 ↗MalfunctionSep 15, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50778590 ↗MalfunctionSep 9, 2026Degraded; Obstruction of Flow
It was reported that during a carotid endarterectomy, the carotid shunt experienced a balloon-related issue. The yellow balloon on the first shunt was reportedly defective, with a "pseudo aneurysm" causing the balloon to become stuck. It is unknown whether the devices were inspected or tested prior to use. The patient possibly has a carotid artery stenosis. No patient injury was reported at the time of the event. Note: This is report 1 of 2 related to the first shunt used in the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50684040 ↗MalfunctionSep 9, 2026Degraded; Inflation Problem
It was reported that during a carotid endarterectomy, the yellow balloon on the shunt did not inflate properly, and the safety balloon inflated before the main balloon. It is unknown whether the devices were inspected or tested prior to use. The patient possibly has a carotid artery stenosis. No patient injury was reported at the time of the event.Note: This is report 2 of 2 related to the second shunt used in the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50684039 ↗MalfunctionApr 2, 2026Leak/Splash
IT WAS REPORTED THAT THE PRUITT F3 SHUNT WAS LEAKING AT THE CONNECTION POINT DURING PRE-USE TESTING. THE DEVICE WAS NOT USED ON A PATIENT. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24764125 ↗MalfunctionMar 30, 2026Leak/Splash
IT WAS REPORTED THAT DURING PRETESTING, THE COMMON CAROTID BALLOON (BLUE BALLOON) DID NOT INFLATE, SUGGESTING A POSSIBLE LEAK. NO ADDITIONAL COMPLICATIONS OR PATIENT INJURY WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24712793 ↗MalfunctionMar 20, 2026Material Deformation; Material Too Soft/Flexible
IT WAS REPORTED THAT TWO PRUITT CAROTID SHUNTS EXPERIENCED ISSUES DURING INTERNAL CAROTID BALLOON INFLATION. IN THE FIRST CASE, THE INTERNAL CAROTID BALLOON RUPTURED ON THE FIRST INFLATION ATTEMPT. IN THE SECOND CASE, THE BALLOON DID NOT INFLATE UNIFORMLY AND APPEARED WEAK, LEADING THE PHYSICIAN TO DISCONTINUE USE OF THE DEVICE. A THIRD SHUNT WAS SUBSEQUENTLY USED AND FUNCTIONED AS INTENDED. NO PATIENT INJURY WAS REPORTED. ONE DEVICE WAS DISCARDED, AND IT IS UNCLEAR WHETHER THE SECOND DEVICE WILL BE RETURNED. NOTE: THIS REPORT IS 2 OF 2 RELATED TO THE SECOND SHUNT USED IN THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24649823 ↗MalfunctionMar 20, 2026Material Rupture
IT WAS REPORTED THAT TWO PRUITT CAROTID SHUNTS EXPERIENCED ISSUES DURING INTERNAL CAROTID BALLOON INFLATION. IN THE FIRST CASE, THE INTERNAL CAROTID BALLOON RUPTURED ON THE FIRST INFLATION ATTEMPT. IN THE SECOND CASE, THE BALLOON DID NOT INFLATE UNIFORMLY AND APPEARED WEAK, LEADING THE PHYSICIAN TO DISCONTINUE USE OF THE DEVICE. A THIRD SHUNT WAS SUBSEQUENTLY USED AND FUNCTIONED AS INTENDED. NO PATIENT INJURY WAS REPORTED. ONE DEVICE WAS DISCARDED, AND IT IS UNCLEAR WHETHER THE SECOND DEVICE WILL BE RETURNED. NOTE: THIS REPORT IS 1 OF 2 RELATED TO THE FIRST SHUNT USED IN THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24649806 ↗MalfunctionMar 13, 2026Material Rupture
IT WAS REPORTED THAT THE PHYSICIAN HAS REPEATEDLY ENCOUNTERED ISSUES WITH THE CAROTID SHUNT DURING PROCEDURES, SPECIFICALLY BALLOON RUPTURE OCCURRING INTRAOPERATIVELY WHILE THE DEVICE WAS IN USE IN THE PATIENT. SPECIFIC DETAILS OF THE EVENTS WERE NOT AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24589548 ↗MalfunctionJan 12, 2026Fluid/Blood Leak
NOTE: A CORRECTION IS BEING SUBMITTED AFTER VIDEO REVIEW, WHICH CONFIRMED THAT THE LEAKAGE ORIGINATED FROM THE BALLOON RATHER THAN THE STOPCOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24045532 ↗MalfunctionDec 16, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE PRUITT F3 CAROTID SHUNT WAS LEAKING PRIOR TO INSERTION INTO PATIENT. IT WAS NOT USED ON THE PATIENT. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23824895 ↗
Other Lemaitre Vascular, Inc. products
- LeMaitre Embolectomy Catheter47 models · 438 reports · 2 recalls
- Artegraft Vascular Graft15 models · 25 reports · 3 recalls
- Trivex System3 models · 69 reports
- Syntel Silicone OTW Embolectomy Catheter8 models · 66 reports
- Syntel Silicone Thrombectomy Catheter5 models · 6 reports · 1 recall
- Pruitt Occlusion Catheter6 models · 5 reports · 1 recall
- Pruitt Irrigation Occlusion Catheter2 models · 4 reports · 1 recall
- LifeSpan ePTFE Vascular Graft10 models · 27 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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