ErgoStar CM 45 MP01845Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048675042631), received between Nov 20, 2025 and Nov 20, 2025 — classified as 1 malfunction.

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

1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Nov 10, 2025Open, Classified

   Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

   Z-0591-2026 · Root cause: Under Investigation by firm · 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.

• MalfunctionNov 20, 2025Disconnection; Insufficient Device Problem Information; Disconnection; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE ERGOSTAR (CATHETER MOUNT) HAD A LOOSE CONNECTION AND SLIPPED OFF DURING USE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23603259 ↗