Pruitt F3 Carotid Shunt 2012-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00840663101238), received between Sep 13, 2017 and Mar 30, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionJun 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PRUITT F3 CAROTID SHUNT BLUE BALLOON RUPTURED DURING TESTING FOR A CAROTID ENDARTERECTOMY PROCEDURE. THE DEVICE WAS NOT DIRECTLY USED ON THE PATIENT. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22197897 ↗
• MalfunctionFeb 13, 2025Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE PRUITT F3 SHUNT INTERNAL BALLOON DID NOT INFLATE DURING PRETESTING FOR A CAROTID ENDARTERECTOMY PROCEDURE. THE COMMON BLUE BALLOON WAS RIPPED. IT WAS NOT USED ON THE PATIENT. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21374732 ↗
• MalfunctionDec 16, 2024Degraded; Mechanical Problem; Degraded; Mechanical Problem

  IT WAS REPORTED THAT THE PRUITT F3 SHUNT HAS A PUNCTURED PROXIMAL BALLOON. FOUND DURING PRE-USE TEST. NO INJURY REPORTED TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20941227 ↗
• MalfunctionSep 24, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHEN THE PRUITT F3 WAS INSERTED AND INSTALLED, A HOLE WAS FOUND IN IT, MAKING IT IMPOSSIBLE TO USE. THE MATERIAL WAS UNIQUE, THEREFORE DOCTOR NEEDED TO CHANGE HIS TECHNIQUE TO COMPLETE THE PROCEDURE. DEVICE WAS NOT IN DIRECT CONTACT WITH THE PATIENT. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20294473 ↗
• MalfunctionSep 18, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PRUITT F3 SHUNT WHITE GUIDE WAS FOUND PUNCTURED DURING PRE-USE CHECK. IT WAS NOT USED ON THE PATIENT. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20249395 ↗
• MalfunctionDec 22, 2021Inflation Problem; Inflation Problem

  ONE OF THE BALLOONS OF THE PRUITT F3 CAROTID SHUNT FAILED TO DEFLATE PROPERLY. USER DID NOT PROVIDE ANY ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13060052 ↗
• MalfunctionJul 17, 2020Mechanical Problem; Mechanical Problem

  DURING PRE-USE CHECK, WHEN SURGEON ATTEMPTED TO INFLATE THE INTERNAL CAROTID BALLOON OF PRUITT F3 CAROTID SHUNT WITH SALINE, HE OBSERVED TWO HOLES IN THE BALLOON. THE SHUNT WAS THEN ISOLATED AND A NEW PRUITT F3 CAROTID SHUNT WAS USED FOR THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10291181 ↗
• MalfunctionMay 2, 2019Deflation Problem; Deflation Problem

  AFTER SUCCESSFULLY COMPLETING THE CAROTID ENDARTECTOMY PROCEDURE, THE SURGEON ATTEMPTED TO DEFLATE THE INTERNAL CAROTID BALLOON BY ASPIRATING THE LIQUID INSIDE THE BALLOON USING A SYRINGE. HOWEVER, HE WAS UNABLE TO DEFLATE THE INTERNAL CAROTID BALLOON. AFTER ATTEMPTING MULTIPLE TIMES, HE WAS ABLE TO PARTIALLY DEFLATE THE BALLOON AND REMOVE IT FROM THE PATIENT'S CAROTID ARTERY. COMMON CAROTID BALLOON DEFLATED PROPERLY. THE SURGICAL TEAM HAD TESTED BOTH BALLOONS BEFORE THE PROCEDURE AND WERE FOUND TO BE FUNCTIONAL. NO FURTHER INTERVENTION WAS NEEDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8573478 ↗
• MalfunctionApr 19, 2019Deflation Problem; Deflation Problem

  SURGEON WAS UNABLE TO REMOVE THE INTERNAL CAROTID BALLOON FROM THE PATIENT'S INTERNAL CAROTID ARTERY AFTER COMPLETION OF CAROTID ENDARTERECTOMY PROCEDURE. SO, HE PUNCTURED THE BALLOON WITH A NEEDLE TO DEFLATE THE BALLOON AND WAS THEN ABLE TO REMOVE IT. NO FURTHER INTERVENTION WAS NEEDED. THE SURGICAL TEAM TESTED THE DEVICE BEFORE THE PROCEDURE AND BOTH BALLOONS WERE FOUND TO BE FUNCTIONAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8532733 ↗
• MalfunctionSep 13, 2017Deflation Problem; Deflation Problem

  DURING A CAROTID ENDARTERECTOMY, THE SURGEON COULD NOT DEFLATE THE INTERNAL CAROTID BALLOON OF THE SHUNT. SURGEON THEN PULLED THE LUMEN OF THE SHUNT TO REMOVE THE INFLATED BALLOON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6862598 ↗

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