ICU Medical 42801-29Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709120785), received between Apr 28, 2025 and Apr 28, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (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.

• MalfunctionApr 28, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A SAFESET¿ 24 INCH ARTERIAL PRESSURE TUBING, SAFESET¿ RESERVOIR AND BLOOD SAMPLING PORT THAT EXPERIENCED LEAKAGE. THE REPORT STATES THAT "WHILE DRAWING BLOODWORK FROM THE PATIENT'S ARTERIAL LINE, THE SAFESET APPEARS TO HAVE CRACKED AND BEGAN LEAKING BLOOD (AT TIP OF SAFESET PLUNGER)". THE CUSTOMER DOES NOT REQUIRE IMMEDIATE REPLACEMENT TO BE ABLE TO CONTINUE OPERATIONS. QUANTITY AFFECTED AND QUANTITY TO BE RETURNED IS 1 EA. DATE OF INCIDENT WAS ON (B)(6) 2025. THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT AND THERE WAS DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21922922 ↗

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