Pruitt Irrigation Occlusion CatheterRecalls & reported problems across all models

We found 2 models of Pruitt Irrigation Occlusion Catheter by Lemaitre Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Oct 29, 2021 and Feb 27, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Failure to Deflate” (2 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Pruitt Irrigation Occlusion Catheter recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Apr 11, 2025Class IIOpen, Classified

   During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).

   Z-1751-2025 · Root cause: Packaging process control · names 2 of these models · Recall details · FDA record ↗

Most reported Pruitt Irrigation Occlusion Catheter problems

Pruitt Irrigation Occlusion Catheter models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Pruitt Irrigation Occlusion Catheter 2102-09

  Occluder, Catheter Tip
  1 recall4 reports
• Pruitt Irrigation Occlusion Catheter e2102-09

  Occluder, Catheter Tip
  1 recall0 reports

Recent Pruitt Irrigation Occlusion Catheter adverse event reports

The 4 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PRUITT IRRIGATION OCCLUSION CATHETER BALLOON RUPTURED WHILE ATTEMPTING TO USE IT TO OCCLUDE VESSEL. IT DID NOT HOLD FLUID TO OCCLUDE VESSEL, EVEN ON FIRST PASS. IT WAS UNSURE IF THE PRODUCT WAS TESTED PRIOR TO USE. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18790728 ↗
• MalfunctionJul 20, 2023Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THE PRUITT IRRIGATION OCCLUSION CATHETER BALLOON DIDN'T DEFLATE. NO INJURY REPORTED TO PATIENT AS THE DEVICE WAS NOT DIRECTLY USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17362430 ↗
• MalfunctionApr 14, 2023Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE PRUITT IRRIGATION OCCLUSION CATHETER BALLOON FAILED TO DEFLATE DURING THE PRE-USE CHECK. THE DEVICE WAS NOT USED FOR THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16742964 ↗
• MalfunctionOct 29, 2021Material Rupture; Material Rupture

  THE CATHETER WAS USED DURING THE REPLACEMENT OF THE ARTIFICIAL BLOOD VESSEL IN THE THORACOABDOMINAL REGION. THE BALLOON OF THE CATHETER RUPTURED DURING THE OPERATION. THE PHYSICIAN REPLACED THAT CATHETER WITH ANOTHER PRUITT IRRIGATION OCCLUSION CATHETER AND CONTINUED THE OPERATION. THERE WAS NO IMPACT ON THE PATIENT BECAUSE OF THE CATHETER MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12719744 ↗

Other Lemaitre Vascular, Inc. products

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