Pruitt Aortic Occlusion Catheter 2100-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00840663101511), received between Aug 22, 2019 and Aug 5, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Perforation” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K872090); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2022Material Integrity Problem; Material Integrity Problem

  WHEN THE PHYSICIAN OPENED THE PACKAGING, THE BALLOON HAD ALREADY RUPTURED IN THE TRAY. THE SURGEON THEN USED ANOTHER PURITT AORTIC OCCLUSION CATHETER TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15178197 ↗
• MalfunctionJun 10, 2020Material Puncture/Hole; Material Perforation; Material Puncture/Hole; Material Perforation

  DURING PRE-USE CHECK, SURGEON NOTICED THE BALLOONS OF THE PRUITT AORTIC OCCLUSION CATHETERS TO BE POROUS. DEVICE WAS NOT USED FOR THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10138637 ↗
• MalfunctionMar 20, 2020Mechanical Problem; Mechanical Problem

  PRUITT AORTIC OCCLUSION CATHETER WAS USED FOR OCCLUDING AORTA DURING ABDOMINAL AORTIC ANEURYSM REPAIR (AAA). SOON AFTER OCCLUDING THE ARTERY WITH THE INFLATED BALLOON OF THE OCCLUSION CATHETER, SURGEON OBSERVED SALINE LEAKAGE FROM THE WHITE STOPCOCK DEFLATING THE BALLOON. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THE DEVICE MALFUNCTION SURGEON USED ANOTHER PRUITT AORTIC OCCLUSION CATHETER AND CONTINUED THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9859553 ↗
• MalfunctionMar 16, 2020Leak/Splash; Leak/Splash

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

  Patient problems: No Patient Involvement

  MAUDE report 9837275 ↗
• MalfunctionSep 27, 2019Material Perforation; Material Perforation

  DURING AN OPEN STENT-GRAFT PLACEMENT FOR TREATING ANEURYSM OF A DESCENDING AORTA, AFTER PROPERLY PLACING THE STENT GRAFT IN HIS AORTA, SURGEON INSERTED AN AORTIC OCCLUSION CATHETER INTO THE STENT GRAFT. HE THEN INFLATED THE BALLOON WITH SALINE AT HIS DESIRED LOCATION TO OCCLUDE THE VESSEL BUT IT IMMEDIATELY RUPTURED. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT. SURGEON REPLACED THE AORTIC OCCLUSION CATHETER AND CONTINUED THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9130893 ↗
• MalfunctionAug 22, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING PRE-USE CHECK, SURGEON DETECTED A LEAKAGE AT THE JOINT WHERE THE INFLATION ARM MEETS THE IRRIGATION LUMEN. DEVICE WAS NOT USED IN THE PATIENT. SURGEON COMPLETED THE PROCEDURE USING ANOTHER PRUITT AORTIC OCCLUSION CATHETER THAT THEY HAD IN STOCK.

  Patient problems: No Patient Involvement

  MAUDE report 8920512 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K872090. One submission often covers many models, so check the product and lot details in each record.

• Z-0219-06 · May 17, 2005 · Terminated
  Product is a Pruitt Aortic Occlusion Catheter contained in a molded tray. The product is labeled in part: ''***LeMaitre VASCULAR***Distributed By:LeMaitre Vascular, Inc.***Manufa