IOPS Mobile Cart MC-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843152100002), received between Nov 7, 2025 and Nov 7, 2025 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K190106, K230309, K261329); 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 16, 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.

• InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE WAS A FEVAR (PMEG) WITH LOWER EXTREMITY ARTERIAL ACCESS. SMA PRE-CANNULATED (QUICKLY), GRAFT PLACED, SMA FEN CANNULATED ALL WITH FLUOROSCOPY. STEERABLE SHEATH PLACED AT FENESTRATION WITH FLUOROSCOPY THEN IOPS USED TO CANNULATE LEFT RENAL ARTERY. REPEATED FOR RIGHT RENAL ARTERY. RIGHT RENAL ARTERY DISSECTED, RECANNULATED WITH GLIDEWIRE. TARGET VESSELS STENTED AND GRAFT FULLY DEPLOYED. NO FURTHER REPORTED EFFECTS ON PATIENT AS THE DISSECTION WAS FULLY TREATED BY THE STENT GRAFT ALREADY BEING PLACED.

  Patient problems: Vascular Dissection

  MAUDE report 23495806 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K190106, K230309, K261329. One submission often covers many models, so check the product and lot details in each record.

• Z-1760-2025 · Apr 11, 2025 · Open, Classified
  Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter