Pruitt F3 Carotid Shunt 2013-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00840663101252), received between Feb 13, 2019 and Sep 29, 2026 — classified as 1 injury, 45 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (20 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 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Leak/Splash; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936609 ↗
• MalfunctionSep 29, 2026Material Rupture; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935304 ↗
• MalfunctionNov 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE SHUNT WAS LEAKING AT THE COUPLING, AND AS A RESULT, IT COULD NOT BE HELD IN PLACE AND SLIPPED OUT. THE SURGEON NOTED THAT THE SHUNT SLIPPED OUT AFTER A SHORT PERIOD OF TIME, AND IT WAS CONCLUDED THAT DECREASED BALLOON PRESSURE CAUSED THE DISPLACEMENT. THE DEVICE WAS CHECKED PRIOR TO USE. THE PATIENT IS DOING WELL, AND A NEW SHUNT WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. THE PRODUCT WAS DISCARDED AND IS NOT AVAILABLE FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23573195 ↗
• MalfunctionNov 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PRUITT F3 CAROTID SHUNT WAS LEAKING AT THE CONNECTION POINT DURING PRE-TESTING. IT WAS NOT USED ON THE PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23571093 ↗
• MalfunctionOct 18, 2024Inflation Problem; Device Dislodged or Dislocated; Inflation Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PRUITT F3 SHUNT INTERNAL BALLOON WAS DISLODGING AND THE SAFETY BALLOON ALSO INFLATED PRIOR TO INTERNAL BALLOON DURING A CAROTID ENDARTERECTOMY PROCEDURE. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20481766 ↗
• MalfunctionSep 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PRUIT F3 CAROTID SHUNT BALLOON RUPTURED DURING A CAROTID ENDARTERECTOMY. THEY HAD TO GET CONTROL WITH SLINGS AROUND THE DISTAL END OF THE SHUNT TO RESOLVE THE ISSUE. NO INJURY WAS REPORTED TO THE PATIENT AND FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20310196 ↗
• MalfunctionSep 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PRUITT F3 CAROTID SHUNT BLUE CAP BALLOON RUPTURED DURING TESTING ON 3 PRODUCTS. IT WAS NOT DIRECTLY USED ON THE PATIENT. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 1 OF 3 RELATED TO THE FIRST SHUNT USED IN THE EVENT. REPORTS 1220948-2024-00174 AND 1220948-2024-00175 WERE SUBMITTED FOR THE SECOND AND THIRD DEVICES INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20310091 ↗
• MalfunctionSep 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PRUITT F3 CAROTID SHUNT BLUE CAP BALLOON RUPTURED DURING TESTING ON 3 PRODUCTS. IT WAS NOT DIRECTLY USED ON THE PATIENT. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 3 OF 3 RELATED TO THE THIRD SHUNT USED IN THE EVENT. REPORTS 1220948-2024-00173 AND 1220948-2024-00174 WERE SUBMITTED FOR THE FIRST AND SECOND DEVICES INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20309911 ↗
• MalfunctionSep 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PRUITT F3 CAROTID SHUNT BLUE CAP BALLOON RUPTURED DURING TESTING ON 3 PRODUCTS. IT WAS NOT DIRECTLY USED ON THE PATIENT. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 2 OF 3 RELATED TO THE SECOND SHUNT USED IN THE EVENT. REPORTS 1220948-2024-00173 AND 1220948-2024-00175 WERE SUBMITTED FOR THE FIRST AND THIRD DEVICES INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20309635 ↗
• MalfunctionSep 19, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PRUITT F3 SAFETY BALLOON LEAKED AT THE YELLOW PART OF THE WHITE TAP LINE WHILE PRIMING FOR A CASE. DEVICE WAS UNABLE TO BE USED. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20260433 ↗
• MalfunctionMay 7, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE THAT PRUITT F3 SHUNT WAS LEAKING FROM THE BLUE STOPCOCK JOINT DURING PRE-USE CHECK. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19265850 ↗
• MalfunctionMar 26, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  BASED ON THE INITIAL INFORMATION, IT WAS REPORTED THAT THE STOPCOCK OF THE DEVICE WAS UNABLE TO BE CLOSED. HOWEVER, AFTER THE PRODUCT WAS RECEIVED AND INSPECTION ON 26 MARCH 2024, IT WAS FOUND THAT THE DEVICE LEAKED AT THE STOPCOCK JOINT WHICH PREVENTED THE BALLOON FROM PROPERLY STAYING INFLATED. AS A RESULT, THIS INCIDENT WAS REASSESSED TO BE A REPORTABLE EVENT. NOTE: SENDING FOLLOW UP DUE TO INCORRECT INFORMATION WAS ACCIDENTALLY ENTERED IN SECTION H11. THE WRITE UP CONTAINED DATA FROM ANOTHER CLAIM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18982812 ↗
• MalfunctionFeb 15, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BALLOON WAS LEAKING ON THE TUBE DURING PRE-USE TEST. THE DEVICE WAS UNABLE TO BE USED FOR THE OPERATION. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18715062 ↗
• MalfunctionNov 2, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THE BALLOON DID NOT INFLATE WHEN USING THIS DEVICE AT THE THROMBUS STENOSIS. IT IS UNCLEAR WHETHER THE BALLOON DID NOT INFLATE FOR THE INTERNAL CAROTID ARTERY OR THE COMMON CAROTID ARTERY. THE OPERATION WAS SUCCESSFULLY COMPLETED USING ANOTHER DEVICE. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18057582 ↗
• MalfunctionNov 1, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THE PRUIT F3 CAROTID SHUNT WHITE BALLOON DEFLATED AFTER IT WAS INFLATED DURING TEST. IT WAS NOT IN DIRECT CONTACT WITH PATIENT. NO INJURY REPORTED TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18049664 ↗
• MalfunctionSep 15, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THE PRUITT F3 CAROTID SHUNT WHITE BALLOON IS NOT INFLATING. IT WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17756658 ↗
• MalfunctionAug 25, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THE WHILE BALLOON WILL NOT INFLATE WITH THE SAFETY BALLOON DEPLOYED. WHEN THE SAFETY BALLOON WAS SQUEEZED THE WHITE BALLOON WOULD INFLATE SLIGHTLY, BUT THEN DEFLATE AGAIN. IT FELT LIKE A LATEX FREE BALLOON. THIS DEVICE WAS NOT USED ON THE PATIENT. NOTE: THIS IS REPORT 3 OF 3 RELATED TO THE THIRD SHUNT THAT WAS TESTED DURING THE EVENT, BUT WAS NOT USED ON THE PATIENT. REPORT 1220948-2023-00133 WAS SUBMITTED FOR THE FIRST DEVICE INVOLVED IN THE EVENT AND REPORT 1220948-2023-00134 WAS SUBMITTED FOR THE SECOND DEVICE TESTED DURING THE EVENT, BUT WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17624255 ↗
• MalfunctionAug 25, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THE WHILE BALLOON WILL NOT INFLATE WITH THE SAFETY BALLOON DEPLOYED. WHEN THE SAFETY BALLOON WAS SQUEEZED THE WHITE BALLOON WOULD INFLATE SLIGHTLY, BUT THEN DEFLATE AGAIN. IT FELT LIKE A LATEX FREE BALLOON. THIS DEVICE WAS NOT USED ON THE PATIENT. NOTE: THIS IS REPORT 2 OF 3 RELATED TO THE SECOND SHUNT THAT WAS TESTED DURING THE EVENT, BUT WAS NOT USED ON THE PATIENT. REPORT 1220948-2023-00133 WAS SUBMITTED FOR THE FIRST DEVICE INVOLVED IN THE EVENT AND REPORT 1220948-2023-00135 WAS SUBMITTED FOR THE THIRD DEVICE TESTED DURING THE EVENT, BUT WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17624253 ↗
• MalfunctionAug 25, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THE WHILE BALLOON WILL NOT INFLATE WITH THE SAFETY BALLOON DEPLOYED DURING A CAROTID ENDARTARECTOMY PROCEDURE. WHEN THE SAFETY BALLOON WAS SQUEEZED THE WHITE BALLOON WOULD INFLATE SLIGHTLY, BUT THEN DEFLATE AGAIN. IT FELT LIKE A LATEX FREE BALLOON. NO INJURY REPORTED TO PATIENT. THEY TESTED TWO OTHER DEVICES FROM THE SAME LOT THAT HAD THE SAME ISSUE, BUT THEY WERE NOT USED ON THE PATIENT. NOTE: THIS IS REPORT 1 OF 3 RELATED TO THE FIRST SHUNT USED IN THE EVENT. REPORT 1220948-2023-00134 AND 1220948-2023-00135 WERE SUBMITTED FOR THE SECOND AND THIRD DEVICE THAT WAS TESTED DURING THE EVENT, BUT WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17624239 ↗
• MalfunctionJul 7, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THE BALLOON WOULD NOT INFLATE AFTER SEVERAL ATTEMPTS. THERE WERE NO INJURY REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17280056 ↗
• MalfunctionJun 23, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER INSERTING THE DEVICE INTO THE INTERNAL CAROTID ARTERY LEAKAGE WAS OBSERVED NEAR THE SYRINGE CONNECTION. AN ALTERNATE DEVICE WAS USED FOR THE PROCEDURE. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17190832 ↗
• MalfunctionMar 23, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PRUITT F3 CAROTID SHUNT WAS LEAKING AT THE JUNCTION OF THE LUMEN AND THE WHITE STOPCOCK. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16600454 ↗
• MalfunctionJan 26, 2023Material Rupture; Device Dislodged or Dislocated; Material Rupture; Device Dislodged or Dislocated

  DURING THE USE OF A PRUITT F3 CAROTID SHUNT, A FEW MINUTES AFTER INSERTING THE DEVICE, THE END INSERTED INTO THE AA COMMON CAROTID ARTERY SLIPPED OFF. THIS INDICATED THAT THE BALLOON HAD RUPTURED. THE SHUNT HAD TO BE REMOVED AND REPLACED, WHICH RESULTED IN BLEEDING AND INCREASING OF THE CEREBRAL ISCHEMIA TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Ischemia

  MAUDE report 16248702 ↗
• MalfunctionJan 20, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED PRUITT F3 CAROTID SHUNT BALLOON WAS NOT INFLATING PROPERLY. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16215134 ↗
• MalfunctionNov 18, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PRUITT F3 CAROTID SHUNT WOULD NOT INFLATE THE BALLOONS. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15825418 ↗

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