Pruitt F3 Carotid Shunt 2012-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 158 adverse event reports that list this exact device (DI 00840663101214), received between Nov 25, 2015 and Sep 22, 2026 — classified as 1 death, 15 injuries, 142 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (32 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 158 reports, in the reporter's own words as published by the FDA.

• 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 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 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 ↗
• MalfunctionNov 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PRUITT F3 CAROTID SHUNT BALLOON RUPTURED DURING PRE-TESTING WHILE INFLATING. IT WAS NOT USED ON THE PATIENT AND NO PATIENT INURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23590438 ↗
• MalfunctionNov 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PRUITT F3 CAROTID SHUNT WAS LEAKING AT THE STOPCOCK JOINT DURING PREPARATION. THE DEVICE WAS NOT USED ON THE PATIENT, AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23590409 ↗
• MalfunctionNov 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING SHUNT PREPARATION, THE SURGEON NOTICED AIR PRESSURE LEAKAGE FROM THE INTERNAL CAROTID BALLOON (WHITE) TO THE SAFETY BALLOON (YELLOW). UPON INSPECTION, SALINE LEAKAGE WAS ALSO OBSERVED AROUND THE SAFETY BALLOON (YELLOW). THE SURGEON CONFIRMED THAT THE RECOMMENDED INFLATION VOLUME OF 0.25 ML WAS STRICTLY FOLLOWED. THE DEVICE WAS NOT USED ON THE PATIENT, AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23530277 ↗
• MalfunctionOct 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PRUITT F3 CAROTID SHUNT WAS OBSERVED TO BE LEAKING AT THE STOPCOCK JOINT DURING A PRE-USE CHECK. IT WAS NOT USED ON THE PATIENT AND NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23404218 ↗
• MalfunctionOct 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PRUITT F3 CAROTID SHUNT WAS FOUND TO BE LEAKING PRIOR TO INSERTION INTO THE PATIENT. THE DEVICE WAS NOT USED, AND NO PATIENT INJURY WAS REPORTED. IT IS UNKNOWN IF THE DEVICE WAS CHECKED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23326321 ↗
• MalfunctionSep 11, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT DURING PREPARATION FOR A CAROTID ENDARTERECTOMY PROCEDURE, THE PRUITT F3 SHUNT SAFETY BALLOON INFLATED PRIOR TO THE INTERNAL CAROTID BALLOON. THE SURGEON WAS NOT COMFORTABLE PROCEEDING AND ELECTED TO USE A DIFFERENT DEVICE. THE ISSUE WAS IDENTIFIED DURING PREPARATION, PRIOR TO USE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23024570 ↗
• MalfunctionSep 3, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, DURING CAROTID SURGERY, THE SHUNT EXPERIENCED SPONTANEOUS RUPTURE OF THE PROXIMAL BALLOON. THE DEVICE WAS USED ACCORDING TO STANDARD PROCEDURE AND WAS INFLATED IN LINE WITH THE MANUFACTURER'S INSTRUCTIONS FOR USE (IFU). NO EXTERNAL FORCE OR MISUSE WAS REPORTED DURING HANDLING. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT UNDERWENT SUCCESSFUL TREATMENT AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2025. 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 22952998 ↗
• MalfunctionSep 3, 2025Material Rupture; Material Rupture

  ON (B)(6) 2025, DURING CAROTID SURGERY, THE SHUNT EXPERIENCED SPONTANEOUS RUPTURE OF THE PROXIMAL BALLOON. THE DEVICE WAS USED ACCORDING TO STANDARD PROCEDURE AND WAS INFLATED IN LINE WITH THE MANUFACTURER'S INSTRUCTIONS FOR USE (IFU). NO EXTERNAL FORCE OR MISUSE WAS REPORTED DURING HANDLING. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT UNDERWENT SUCCESSFUL TREATMENT AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2025. 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 22952962 ↗
• MalfunctionAug 28, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PRUITT F3 CAROTID SHUNT CONNECTION PORT LEAKING DURING PRE-TEST. IT WAS NOT USED ON THE PATIENT AND NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22911057 ↗
• MalfunctionAug 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PRUITT F3 CAROTID SHUNT BALLOON RUPTURED IN THE MIDDLE OF A CAROTID ENDARTERECTOMY (CEA) PROCEDURE. THE DOCTORS ALMOST FINISHED SUTURING THE PATCH ON THE CAROTID ARTERY WHEN THE INCIDENT HAPPENED. THEY PROCEEDED WITH CLAMPS AND QUICKLY FINISHED THE REMAINING SUTURES. AFTER THE SHUNT WAS REMOVED, DR. (B)(6) DID FURTHER INSPECTION ON THE BALLOON; NO PARTS OR SMALL PIECES OF THE BALLOON CAME OFF THE BALLOON. DEVICE WAS PRE-CHECKED PRIOR TO USE. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22739226 ↗
• MalfunctionAug 7, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PRUITT F3 CAROTID SHUNT CONNECTION PORT WAS LEAKING. IT WAS NOT USED ON THE PATIENT. NO INJURY REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22738470 ↗
• MalfunctionAug 4, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PRUITT F3 SHUNT WAS LEAKING AT THE CONNECTION PORT DURING PRE-USE CHECK. IT WAS NOT DIRECTLY USED ON THE PATIENT AND NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22710733 ↗
• MalfunctionJul 30, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PRUITT F3 SHUNT CONNECTION PORT WAS LEAKING DURING PRE-USE CHECK; HOWEVER, BASED ON THE VIDEO PROVIDED IT SHOWS A HOLE IN THE INTERNAL BALLOON. IT WAS NOT USED ON THE PATIENT AND NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22672736 ↗
• MalfunctionJul 30, 2025Material Rupture; Thickening of Material; Material Rupture; Thickening of Material

  IT WAS REPORTED THAT BALLOON THICKENED AND RUPTURED DURING PRE-TESTING. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 8 OF 8 RELATED TO THE EIGHTH SHUNT USED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22662342 ↗
• MalfunctionJul 30, 2025Material Rupture; Thickening of Material; Material Rupture; Thickening of Material

  IT WAS REPORTED THAT BALLOON THICKENED AND RUPTURED DURING USE ON A PATIENT. HOWEVER, ADDITIONAL INFORMATION RECEIVED STATES THAT THE BALLOON RUPTURE DID NOT OCCUR ON A PATIENT AND WAS DURING PRE-TESTING. OVER THE PAST 2 MONTHS THERE HAVE CASES OF THE BALLOON RUPTURING DURING THE PRE-USE CHECK. WE ATTEMPTED TO CLARIFY THE REPORT, BUT IT WAS NOT SUCCESSFUL. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 7 OF 8 RELATED TO THE SEVENTH SHUNT USED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22662273 ↗
• MalfunctionJul 30, 2025Material Rupture; Thickening of Material; Material Rupture; Thickening of Material

  IT WAS REPORTED THAT BALLOON THICKENED AND RUPTURED DURING USE ON A PATIENT. HOWEVER, ADDITIONAL INFORMATION RECEIVED STATES THAT THE BALLOON RUPTURE DID NOT OCCUR ON A PATIENT AND WAS DURING PRE-TESTING. OVER THE PAST 2 MONTHS THERE HAVE CASES OF THE BALLOON RUPTURING DURING THE PRE-USE CHECK. WE ATTEMPTED TO CLARIFY THE REPORT, BUT IT WAS NOT SUCCESSFUL. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 6 OF 8 RELATED TO THE SIXTH SHUNT USED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22662101 ↗
• MalfunctionJul 30, 2025Material Rupture; Thickening of Material; Material Rupture; Thickening of Material

  IT WAS REPORTED THAT BALLOON THICKENED AND RUPTURED DURING USE ON A PATIENT. HOWEVER, ADDITIONAL INFORMATION RECEIVED STATES THAT THE BALLOON RUPTURE DID NOT OCCUR ON A PATIENT AND WAS DURING PRE-TESTING. OVER THE PAST 2 MONTHS THERE HAVE CASES OF THE BALLOON RUPTURING DURING THE PRE-USE CHECK. WE ATTEMPTED TO CLARIFY THE REPORT, BUT IT WAS NOT SUCCESSFUL. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 5 OF 8 RELATED TO THE FIFTH SHUNT USED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22662051 ↗

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 · Terminated
  LeMaitre 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