ICU Medical 50134-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840619040932), received between Nov 21, 2023 and Nov 21, 2023 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K052828); 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.

• MalfunctionNov 21, 2023Material Frayed; Material Frayed

  THE EVENT INVOLVED A CARDIAC OUTPUT CABLE WHERE IT WAS REPORTED THAT THE RUBBER PIECE CLOSE TO THE CONNECTION TO THE CATHETER SLIPS OFF VERY EASILY CAUSING WIRE EXPOSURE. THE PRODUCT WAS NOT REPROCESSED OR RE-STERILIZED PRIOR TO USE. THE CUSTOMER REPORTED THEY ARE HAVING TROUBLE WITH THE ADHESIVE ON THE CABLES, AND HAVE SEEN THE DAMAGE WHEN CABLES ARE TAKEN OUT OF THE PACKAGING AND PLUGGING THEM IN. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18182897 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052828. One submission often covers many models, so check the product and lot details in each record.

• Z-1071-2019 · Nov 27, 2018 · Terminated
  ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Squeeze Flush, Macrodrip (Pole Mount), REF: 42640-06