Pruitt F3 Carotid Shunt e2012-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00840663101283), received between Dec 8, 2015 and Sep 21, 2026 — classified as 3 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (13 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 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50844612 ↗
• MalfunctionOct 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED TO THE FDA THAT THE PRUITT F3 SHUNT WAS LEAKING DUE TO A HOLE IN THE WHITE PORT TUBE DURING A LEFT CAROTID ENDARTERECTOMY WITH BOVINE PERICARDIAL PATCH ANGIOPLASTY. IT IS UNKNOWN WHETHER THE DEVICE WAS CHECKED PRIOR TO USE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23348382 ↗
• MalfunctionSep 16, 2025Fluid/Blood Leak; Material Puncture/Hole

  LEAKING HOLE ALONG THE WHITE PORT TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23061824 ↗
• MalfunctionJul 22, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PRUITT F3 SHUNT LEAKED AT THE DISTAL INFLATION PORT DURING PRE-USE CHECK. IT WAS NOT USED DIRECTLY ON THE PATIENT. A REPLACEMENT SHUNT WAS USED TO COMPLETE THE OPERATION. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22572865 ↗
• MalfunctionMay 1, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT A HOLE WAS FOUND IN THE TUBING DURING FLUSHING OF THE PRUITT F3 CAROTID SHUNT. THE ISSUE WAS FOUND DURING PREPPING PRIOR TO INSERTION INTO THE PATIENT; THEREFORE, IT WAS NOT USED. 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 21943214 ↗
• MalfunctionFeb 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PRUITT F3 SHUNT BALLOON RUPTURED DURING CAROTID ENDARTERECTOMY PROCEDURE. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21373971 ↗
• MalfunctionOct 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PRUITT F3 CAROTID SHUNT BALLOON RUPTURED DURING A CAROTID ENDARTERECTOMY PROCEDURE. THE ISSUE WAS DETECTED DUE TO THE BALLOON LEAKING AND WAS CLAMPED TO ADDRESS IT. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 1 OF 2 RELATED TO THE FIRST EVENT/DEVICE. REPORT 1220948-2024-00211 WAS SUBMITTED FOR THE SECOND DEVICE/EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20481709 ↗
• MalfunctionAug 15, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PRUITT F3 SHUNT INTERNAL CAROTID LUMEN WAS LEAKING NEAR THE SAFETY BALLOON DURING A CAROTID ENDARTERECTOMY PROCEDURE. THE DEVICE WAS NOT CHECKED PRIOR TO USE. THE LEAK WAS CLAMPED RIGHT ABOVE IT TO RESOLVE THE ISSUE. NOTE: THIS IS REPORT 2 OF 2 RELATED TO THE SECOND SHUNT USED IN THE EVENT. REPORT 1220948-2024-00150 WAS SUBMITTED FOR THE FIRST DEVICE INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19995714 ↗
• MalfunctionAug 15, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PRUITT F3 SHUNT INTERNAL CAROTID LUMEN WAS LEAKING NEAR THE SAFETY BALLOON DURING A CAROTID ENDARTERECTOMY PROCEDURE. THE DEVICE WAS NOT CHECKED PRIOR TO USE. THE LEAK WAS CLAMPED RIGHT ABOVE IT TO RESOLVE THE ISSUE. NOTE: THIS IS REPORT 1 OF 2 RELATED TO THE FIRST SHUNT USED IN THE EVENT. REPORT 1220948-2024-00157 WAS SUBMITTED FOR THE SECOND DEVICE INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19995329 ↗
• MalfunctionJun 14, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PRUITT F3 CAROTID SHUNT WAS FOUND DEFECTIVE WHEN PREPPING FOR A CAROTID ENDARTERECTOMY PROCEDURE. ACCORDING TO THE USER, THERE WAS A HOLE IN THE SHUNT LUMEN THAT LEAKED WHEN FLUSHED WITH SALINE DURING PRE-USE CHECK. IT WAS NOT IN DIRECT USE ON THE PATIENT. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19537343 ↗
• MalfunctionApr 12, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PRUITT CAROTID SHUNT BALLOON WOULD NOT INFLATE BECAUSE THE SLIDER KEPT COMING OFF THE SAFETY BALLOON DURING A CAROTID ENDARTERECTOMY PROCEDURE. A DIFFERENT SHUNT WAS USED. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 2 OF 2 RELATED TO THE SECOND SHUNT USED IN THE EVENT. REPORT 1220948-2043-00085 WAS SUBMITTED FOR THE FIRST DEVICE INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19096615 ↗
• MalfunctionApr 12, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE PRUITT CAROTID SHUNT BALLOON WOULD NOT DEFLATE DURING A CAROTID ENDARTERECTOMY PROCEDURE. ADJUSTMENT WAS MADE TO THE SHUNT UNTIL THE BALLOON DEFLATED. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 1 OF 2 RELATED TO THE FIRST SHUNT USED IN THE EVENT. REPORT 1220948-2043-00086 WAS SUBMITTED FOR THE SECOND DEVICE INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19096594 ↗
• MalfunctionFeb 2, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PRUITT F3: CAROTID SHUNT BALLOON IS DEFECTIVE ON THE WHITE END DURING A LEFT CAROTID ENDARTERECTOMY PROCEDURE. IT WAS CLAMPED BY THE SURGEON AND THE SHUNT WAS STILL ABLE TO BE USED. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18634250 ↗
• InjuryJan 16, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT TWO PRUITT F3 CAROTID SHUNTS HAD A DEFECT IN THE TUBING THAT CAUSED INFLATION IN WRONG PART OF TUBING LEADING TO UNDERINFLATION OF THE FIXATED BALLOON WHICH CAUSED DISLOCATION OF THE SHUNT AND BLEEDING DURING A LEFT CAROTID ENDARECTOMY PROCEDURE. THEY ARE UNSURE IF THE DEVICES WERE CHECKED PRIOR TO USE. NO OTHER INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 2 OF 2 RELATED TO THE SECOND SHUNT USED IN THE EVENT. REPORT 1220948-2024-00018 WAS SUBMITTED FOR THE FIRST DEVICE INVOLVED IN THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18521442 ↗
• InjuryJan 16, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT TWO PRUITT F3 CAROTID SHUNTS HAD A DEFECT IN THE TUBING THAT CAUSED INFLATION IN WRONG PART OF TUBING LEADING TO UNDERINFLATION OF THE FIXATED BALLOON WHICH CAUSED DISLOCATION OF THE SHUNT AND BLEEDING DURING A LEFT CAROTID ENDARECTOMY PROCEDURE. THEY ARE UNSURE IF THE DEVICES WERE CHECKED PRIOR TO USE. NO OTHER INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 1 OF 2 RELATED TO THE FIRST SHUNT USED IN THE EVENT. REPORT 1220948-2024-00019 WAS SUBMITTED FOR THE SECOND DEVICE INVOLVED IN THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18521408 ↗
• MalfunctionJan 10, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE PRUITT F3 CAROTID SHUNT WHITE BALLOON WOULD NOT HOLD WHEN INSERTED INTO THE VESSEL DURING A CAROTID ENDARTERECTOMY PROCEDURE. IT WAS REPLACED WITH ANOTHER PRUITT CAROTID SHUNT. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18486491 ↗
• MalfunctionDec 13, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED TWO PRUITT F3 CAROTID SHUNTS INFLATION OCCURRED ON THE SURGICAL FIELD SIDE INSTEAD OF IN THE VESSEL DURING A CAROTID ENDARTERECTOMY PROCEDURE. THIS CAUSED THE INTERNAL BALLOON TO NOT INFLATE AS TIGHT AS IT SHOULD WHICH CAUSED BLEEDING. NOTE: THIS IS REPORT 1 OF 2 RELATED TO THE FIRST CATHETER USED IN THE EVENT. REPORT 1220948-2023-00206 WAS SUBMITTED FOR THE SECOND DEVICE INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18315981 ↗
• MalfunctionDec 13, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED TWO PRUITT F3 CAROTID SHUNTS INFLATION OCCURRED ON THE SURGICAL FIELD SIDE INSTEAD OF IN THE VESSEL DURING A CAROTID ENDARTERECTOMY PROCEDURE. THIS CAUSED THE INTERNAL BALLOON TO NOT INFLATE AS TIGHT AS IT SHOULD WHICH CAUSED BLEEDING. NOTE: THIS IS REPORT 2 OF 2 RELATED TO THE SECOND CATHETER USED IN THE EVENT. REPORT 1220948-2023-00205 WAS SUBMITTED FOR THE FIRST DEVICE INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18315980 ↗
• MalfunctionSep 23, 2023Failure to Deflate; Failure to Deflate

  IT WAS REPORTED PRUITT F3 CAROTID SHUNT BLUE BALLOON WOULD NOT DEFLATE AT THE END OF A CAROTID ENDARTERECTOMY PROCEDURE. THE BALLOON WAS REMOVED WHILE STILL INFLATED. NO INJURY REPORTED TO PATIENT. PATIENT IS DOING FINE POST OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17804958 ↗
• MalfunctionAug 30, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON OF THE SHUNT WOULD NOT INFLATE. IT WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17653204 ↗
• MalfunctionAug 29, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED A LEAK WAS FOUND AROUND THE JUNCTION OF THE FLUSH PORT OF THE SHUNT. NO INJURY TO PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17644420 ↗
• MalfunctionJul 25, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED PRUITT F3 SHUNT WHITE BALLOON LEAKED DURING TEST PRIOR TO USE. ISSUE WAS FOUND PRIOR TO USE. NO INURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17387906 ↗
• MalfunctionJul 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT PRUITT F3 SHUNT BALLOON RUPTURED DURING TESTING FOR CAROTID ENDARTERECTOMY. IT WAS NOT USED ON PATIENT AS THE ISSUE OCCURRED DURING TESTING PRIOR TO THE CAROTID ENDARTERECTOMY PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17316899 ↗
• MalfunctionJun 23, 2023Unintended Deflation; Unintended Deflation

  IT WAS REPORTED PRUITT F3 SHUNT BLUE BALLOON DEFLATED AND SLIPPED OUT OF CAROTID ARTERY (COMMON CAROTID) DURING SURGERY. NO INJURY REPORTED TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17190938 ↗
• MalfunctionApr 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A LEFT CAROTID ENDARTERECTOMY PROCEDURE, THE PRUITT F3 CAROTID SHUNT W/ T-PORT (OUTLYING) HAS A LEAK IN THE INFLATION PORT FOR THE COMMON CAROTID BALLOON. NO INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16777630 ↗

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