Pruitt Occlusion Catheter 2103-56Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840663101573), received between Mar 8, 2024 and Mar 8, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K811276); 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.

Recalls naming this device

1. Apr 11, 2025Class IIOpen, Classified

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

   Z-1752-2025 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2024Material Rupture; Material Rupture

  THE PRUITT OCCLUSION CATHETER (POC) AND XENOSURE WERE USED IN ONE CASE OF ENDARTERECTOMY + EVT. AFTER ENDARTERECTOMY OF THE RIGHT FEMORAL ARTERY AND PLACEMENT OF A METAL STENT, THE SHAFT OF THE POC WAS INSERTED INTO THE VESSEL TO PLACE A PATCH AT THE ENDARTERECTOMY SITE. HOWEVER, THE BALLOON OF THE POC RUPTURED, SO THE BLOOD FLOW COULD NOT BE BLOCKED. SINCE THE STENT WAS PLACED ON THE PROXIMAL SIDE OF THE ENDARTERECTOMY SITE, IT WAS NOT POSSIBLE TO OCCLUDE THE BLOOD VESSEL USING VASCULAR CLAMP. SO, PTA BALLOON WAS USED INSTEAD TO OCCLUDE THE BLOOD FLOW. THE XENOSURE PATCH WAS SUTURED TO THE ENDARTERECTOMY SITE AND THE SURGERY WAS COMPLETED. THE PATIENT IS DOING WELL AND THERE WERE NO HEALTH COMPLICATIONS. THE CAUSE OF THE BALLOON RUPTURE APPEARS TO BE CONTACT WITH THE METAL PART OF THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18865689 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K811276. One submission often covers many models, so check the product and lot details in each record.

• Z-1751-2025 · Apr 11, 2025 · Open, Classified
  Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56