Pruitt F3 Carotid Shunt e2012-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00840663101290), received between Jun 4, 2019 and Sep 3, 2024 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Failure to Deflate” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE WHITE INTERNAL CAROTID BALLOON WOULD NOT INFLATE DURING THE PROCEDURE. A STENT WAS PLACED TO RESOLVE THE ISSUE. THE BLEEDING WAS ABLE TO BE CONTROLLED, AND NO HARM OCCURRED TO THE PATIENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20127683 ↗
• MalfunctionMar 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PRUITT F3 CAROTID SHUNT TUBE HAS HOLE IN IT. THE ISSUE WAS FOUND DURING PRE-USE CHECK AND NO INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16513554 ↗
• MalfunctionNov 16, 2022Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE SURGEON HAD AN ISSUE WHILE USING A PRUITT F3 CAROTID SHUNT. AT THE END OF THE PROCEDURE, THE BALLOON WOULD NOT DEFLATE, SO THEY HAD TO MANUALLY POP THE BALLOON TO REMOVE THE DEVICE. THERE WAS NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15806115 ↗
• MalfunctionSep 16, 2022Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT THE PRUITT F3 CAROTID SHUNT WAS INFLATED IN THE INTERNAL ARTERY FOR A CEA PROCEDURE, BUT WHILE THE SURGEON WAS OPERATING THE BALLOON DEFLATED. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15439665 ↗
• MalfunctionSep 16, 2022Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE SITE HAS AN ISSUE WITH THE PRUITT F3 CAROTID SHUNT WHERE THE BALLOON IS NOT DEFLATING AFTER REMOVING THE DEVICE FROM THE PACKAGE. THE ISSUE WAS NOTED PRIOR TO USE ON A PATIENT. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15439634 ↗
• MalfunctionApr 8, 2022Failure to Deflate; Failure to Deflate

  AFTER COMPLETING CAROTID ENDARTERECTOMY (CEA) PROCEDURE, WHEN THE SURGEON ATTEMPTED TO DEFLATE ONE OF THE BALLOONS OF THE PRUITT F3 CAROTID SHUNT, HE WAS UNABLE TO DO SO. SO, HE MANUALLY POPPED THE BALLOON TO REMOVE IT FROM THE PATIENT'S BLOOD VESSEL. THERE WAS NO HARM TO THE PATIENT BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14058977 ↗
• MalfunctionApr 8, 2022Failure to Deflate; Failure to Deflate

  AFTER COMPLETING CAROTID ENDARTERECTOMY (CEA) PROCEDURE, WHEN THE SURGEON ATTEMPTED TO DEFLATE ONE OF THE BALLOONS OF THE PRUITT F3 CAROTID SHUNT, HE WAS UNABLE TO DO SO. SO, HE MANUALLY POPPED THE BALLOON TO REMOVE IT FROM THE PATIENT'S BLOOD VESSEL. THERE WAS NO HARM TO THE PATIENT BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14058792 ↗
• MalfunctionMar 12, 2020Fluid/Blood Leak; Fluid/Blood Leak

  DURING PRE-USE CHECK, WHEN SURGEON ATTEMPTED TO INFLATE THE INTERNAL CAROTID BALLOON WITH SALINE, HE OBSERVED A LEAKAGE AT THE SAFETY BALLOON. DEVICE WAS NOT USED FOR THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9826199 ↗
• MalfunctionJul 24, 2019Deflation Problem; Deflation Problem

  DURING PRE-USE CHECK, COMMON CAROTID BALLOON FAILED TO DEFLATE COMPLETELY.

  Patient problems: No Patient Involvement

  MAUDE report 8823219 ↗
• MalfunctionJun 4, 2019Deflation Problem; Deflation Problem

  DURING THE CAROTID ENDARTERECTOMY 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. THE SURGICAL TEAM HAD TESTED BOTH BALLOONS BEFORE THE PROCEDURE AND BOTH WERE FOUND TO BE FUNCTIONAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8667744 ↗

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