Pruitt F3 Carotid Shunt e2013-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00840663101320), received between Mar 13, 2019 and May 2, 2025 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (6 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PRUITT F3 CAROTID SHUNT WHITE BALLOON WAS NOT INFLATING DURING A CAROTID ENDARTERECTOMY PROCEDURE. IT WAS NOT USED ON THE PATIENT. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE OPERATION. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21950356 ↗
• MalfunctionJul 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PRUITT F3 CAROTID SHUNT BALLOON RUPTURED DURING USE. THE DAMAGE WAS NOTICED AFTER REMOVAL FROM CAROTID ARTERY DURING CEA PROCEDURE. IT IS UNKNOWN IF THE DAMAGE OCCURRED WHILE IN THE ARTERY OR FROM BEING CLAMPED. A REPLACEMENT SHUNT WAS USED. NO INJURY TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17267937 ↗
• MalfunctionJun 30, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED PRUITT F3 CAROTID SHUNT HAD A SLIGHT LEAK AT THE CONNECTION OF THE STOPCOCK AND TUBE OF THE INTERNAL CAROTID BALLOON DURING CAROTID ENDARTERECTOMY PROCEDURE. THE SHUNT WAS DISPOSED OF AND A REPLACEMENT WAS USED. NO INJURY OCCURRED TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17239920 ↗
• MalfunctionApr 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO PRUITT F3 CAROTID SHUNT DEVICES WERE LEAKING AROUND THE BALLOON. THE ISSUE WAS NOTED DURING THE PRE-USE CHECK AND THE DEVICES WERE NOT USED ON THE PATIENT. PLEASE NOTE THIS IS REPORT 2 OF 2. REPORT 1220948-2023-00054 WAS ALSO SUBMITTED FOR THE INITIAL DEVICE INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16752960 ↗
• MalfunctionApr 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO PRUITT F3 CAROTID SHUNT DEVICES WERE LEAKING AROUND THE BALLOON. THE ISSUE WAS NOTED DURING THE PRE-USE CHECK AND THE DEVICES WERE NOT USED ON THE PATIENT. PLEASE NOTE THIS IS REPORT 1 OF 2. REPORT 1220948-2023-00055 WAS ALSO SUBMITTED FOR THE SECOND DEVICE INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16752952 ↗
• MalfunctionJul 28, 2022Material Integrity Problem; Material Integrity Problem

  DURING PRE-USE CHECK, THE USER OBSERVED THE BALLOONS OF THE PRUITT F3 CAROTID SHUNT WERE DRY. SHE OBSERVED THE SALINE WAS LEAKING FROM THE BALLOONS WHEN SHE ATTEMPTED TO INFLATE THE BALLOONS. SO, A SECOND PRUITT F3 CAROTID WAS OPENED AND PREPARED FOR THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15125046 ↗
• MalfunctionMay 26, 2021Fluid/Blood Leak; Fluid/Blood Leak

  DURING PRE-USE CHECK, WHEN THE SURGEON ATTEMPTED TO INFLATE THE INTERNAL CAROTID BALLOON WITH SALINE, THE BALLOON DID NOT INFLATE PROPERLY. THE MALFUNCTION WAS DETECTED DURING THE PRE-USE CHECK. THE SURGEON USED ANOTHER F3 SHUNT FOR THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11888564 ↗
• MalfunctionFeb 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  DURING PRE-USE CHECK, WHEN THE SURGEON ATTEMPTED TO INFLATE THE INTERNAL CAROTID BALLOON WITH SALINE, HE OBSERVED A LEAKAGE AT THE STOPCOCK JOINT. THE MALFUNCTION WAS DETECTED DURING PRE-USE CHECK. SURGEON USED ANOTHER F3 SHUNT FOR THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11368857 ↗
• MalfunctionNov 22, 2019Material Puncture/Hole; Material Puncture/Hole

  SURGEON REPORTED THAT HE OBSERVED A HOLE IN ONE OF THE OCCLUSION BALLOON. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9365969 ↗
• MalfunctionSep 13, 2019Inflation Problem; Inflation Problem

  DURING PRE-USE CHECK, WHEN THE USER ATTEMPTED TO INFLATE THE COMMON CAROTID BALLOON WITH SALINE, HE DETECTED A LEAK AT A JOINT BETWEEN THE STOPCOCK AND THE COMMON CAROTID BALLOON INFLATION ARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9047494 ↗
• MalfunctionJun 28, 2019Inflation Problem; Inflation Problem

  DURING PRE-USE CHECK, USER DETECTED A LEAKAGE AT THE SAFETY BALLOON WHEN HE ATTEMPTED INFLATE THE INTERNAL CAROTID BALLOON WITH SALINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8745612 ↗
• MalfunctionJun 28, 2019Inflation Problem; Inflation Problem

  DURING PRE-USE CHECK, ONE OF THE BALLOONS OF THE F3 CAROTID SHUNT DID NOT INFLATE WHEN THE USER ATTEMPTED INFLATING IT WITH SALINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8743929 ↗
• MalfunctionJun 27, 2019Inflation Problem; Inflation Problem

  DURING PRE-USE CHECK, THE BALLOONS OF THE F3 SHUNT INFLATED UNSYMMETRICALLY WHEN THE BALLOONS WERE INFLATED WITH RECOMMENDED VOLUME OF SALINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8740231 ↗
• MalfunctionJun 26, 2019Deflation Problem; Deflation Problem

  COMMON CAROTID BALLOON LEAKED DURING PRE-USE CHECK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8737095 ↗
• MalfunctionJun 12, 2019Material Integrity Problem; Material Integrity Problem

  DURING PRE-USE CHECK, WHEN THE NURSE INFLATED THE COMMON CAROTID BALLOON WITH SALINE, SHE DETECTED A LEAK AT A JOINT BETWEEN THE STOPCOCK AND THE COMMON CAROTID BALLOON INFLATION ARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8692777 ↗
• MalfunctionApr 24, 2019Material Puncture/Hole; Material Puncture/Hole

  SURGEON DETECTED A LEAKAGE ON THE SAFETY BALLOON DURING PRE-USE CHECK. SO, SURGEON USED ANOTHER F3 SHUNT FOR THE CAROTID ENDARTERECTOMY PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8545785 ↗
• MalfunctionMar 13, 2019Inflation Problem; Inflation Problem

  DURING PRE-USE CHECK, THE BALLOONS OF THE F3 SHUNT FAILED TO INFLATE SYMMETRICALLY WHEN THE BALLOONS WERE INFLATED WITH RECOMMENDED VOLUME OF SALINE.

  Patient problems: No Information

  MAUDE report 8417936 ↗

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