Pruitt F3 Carotid Shunt 2012-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840663101245), received between Sep 25, 2018 and Oct 10, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2018Deflation Problem; Deflation Problem

  THE SURGEON EXPERIENCED RESISTANCE WHILE REMOVING ONE OF THE ARMS OF THE SHUNT AFTER THE CAROTID ENDARTERECTOMY PROCEDURE. HE WAS ABLE TO COMPLETELY REMOVE THE ARM WITHOUT ANY VESSEL INJURY. HE OBSERVED THE BALLOON ON THIS ARM OF THE SHUNT HAD ONLY PARTIALLY DEFLATED, RESULTING IN THIS ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7952762 ↗
• MalfunctionSep 25, 2018Flaked; Flaked

  DURING ENDARTERECTOMY PROCEDURE, SURGEON NOTICED THE INK MARKINGS FROM THE LUMEN OF THE SHUNT HAD FLAKED OFF.

  Patient problems: No Information

  MAUDE report 7908063 ↗

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