AngioJet® XMI® 105041-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729889151), received between Oct 10, 2018 and Oct 10, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (1 report).

2 other recalls cover devices cleared under the same FDA submission (P980037); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2018Display or Visual Feedback Problem; Suction Problem; Display or Visual Feedback Problem; Suction Problem

  IT WAS REPORTED THAT AN ERROR MESSAGE OCCURRED DURING PROCEDURE. AN ANGIOJET XMI CATHETER WAS SELECTED FOR USE FOR A THROMBECTOMY PROCEDURE IN THE POPLITEAL ARTERY. WHEN THE PHYSICIAN ATTEMPTED THROMBECTOMY IN THE ARTERY, THE CONSOLE DISPLAYED AN ERROR MESSAGE "CHECK KINKS" AND THE CATHETER ONLY DID ABOUT 20 MORE PUMPS. THE PHYSICIAN REMOVED THE CATHETER FROM THE PATENT AND USED ANOTHER ANGIOJET XMI CATHETER TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS POST PROCEDURE WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7951842 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P980037. One submission often covers many models, so check the product and lot details in each record.

• Z-0717-2020 · Nov 8, 2019 · Terminated
  AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H 105650-001R 105650-001Z 105650-002R 105650-004H 105650-004R 105650-007R 105650-009R 105650-024H
• Z-1401-2017 · Jan 31, 2017 · Terminated
  AngioJet Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 Cardiovascular: The Console is a multiple-use device that controls the Thrombectomy Set. It drives the pump