ICU Medical 12627Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887709042391), received between Aug 21, 2024 and Sep 30, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K974589); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 1O2¿ VALVE (BLUE) W/CHECK VALVE, ROTATING LUER WHERE THE CUSTOMER REPORTED THAT A LEAK OCCURRED DURING USE ON A 70 YEAR OLD MALE PATIENT. THE INCIDENT OCCURRED IN A MEDICAL INSTITUTION AND THE PATIENT WAS BEING TREATED FOR MULTIFUNCTIONAL ORGAN FAILURE AND REHYDRATION TREATMENT WHEN LIQUID SEEPAGE WAS FOUND AT THE CONNECTION OF THE WANTONG VALVE DURING FLUID REHYDRATION TREATMENT. A NEW WANTONG VALVE WAS IMMEDIATELY REPLACED AND THE LIQUID WAS INPUT SMOOTHLY. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334467 ↗
• MalfunctionAug 21, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 1O2¿ VALVE (BLUE) W/CHECK VALVE, ROTATING LUER WHERE THE REPORTER STATED THERE WAS LEAKAGE FROM THE WHITE BUTTON. .THE CUSTOMER REPORTED THAT OCCURRED DURING INFUSION BETWEEN (B)(6) 2024 AND WAS USED FOR 24 HOURS. THE DEVICES WERE CHANGED OUT/REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. THERE WERE 6 PROBLEMATIC DEVICES. THERE WAS NO SERIOUS INJURY/DEATH, NO BLOOD LOSS, NO UNPROTECTED CHEMO EXPOSURE, NO ADVERSE OPERATOR CONSEQUENCES AND NO MEDICAL/SURGICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20013512 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K974589. One submission often covers many models, so check the product and lot details in each record.

• Z-3160-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers
• Z-0257-2021 · Jul 6, 2020 · Terminated
  98 IN (249cm) APPX 8.4 ml, 60 Drop Set, 2 Clave, REMV 2 Clave STOPCOCKS. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709076119(17)250101(30)25(10)4584862. The SmartValve i
• Z-0252-2021 · Jul 6, 2020 · Terminated
  120 IN (305cm)APPX 15.4ml, 10 DROP, 2 Clave STOPCOCK, NanoClave T-Connector, 2 CHECK VALVES. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709040141(17)250101(30)25(10)45736