Pruitt F3 Carotid Shunt 2011-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00840663101191), received between Nov 26, 2019 and Mar 20, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionFeb 9, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON OF THE PRUITT F3 CAROTID SHUNT WOULD DEFLATE INTO THE SAFETY BALLOON. AS A RESULT, THE SHUNT WAS NOT TIGHT AND HAD TO BE REPLACED. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16340463 ↗
• MalfunctionFeb 19, 2021Material Rupture; Material Rupture

  THE INTERNAL CAROTID BALLOON OF THE F3 CAROTID SHUNT WAS DAMAGED DURING THE CAROTID ENDARTERECTOMY PROCEDURE. THE SURGEON THEN USED ANOTHER F3 CAROTID SHUNT AND CONTINUED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11352820 ↗
• InjuryNov 26, 2019Material Puncture/Hole; Material Puncture/Hole

  AT A BEGINNING OF A CAROTID ENDARTERECTOMY (CEA) PROCEDURE, USING A F3 CAROTID SHUNT, WHEN SURGEON ATTEMPTED TO OCCLUDE THE COMMON CAROTID ARTERY BY INFLATING THE COMMON CAROTID BALLOON WITH SALINE, HE OBSERVED THE BALLOON WAS LEAKING AND WAS UNABLE TO OCCLUDE THE COMMON CAROTID ARTERY RESULTING IN BLOOD LEAKAGE FROM THE ARTERY. SURGEON CLAMPED THE COMMON CAROTID ARTERY AND COMPLETED THE PROCEDURE WITHOUT ANY FURTHER COMPLICATIONS. SURGEON INSPECTED THE BALLOONS DURING PRE-USE CHECK AND FOUND THEM TO BE OPERATIONAL.

  Patient problems: Blood Loss

  MAUDE report 9377525 ↗

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