ICU Medical 42800-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887709097605), received between Aug 7, 2024 and Aug 7, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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.

• MalfunctionAug 7, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A TRANSDUCER, 84 INCH (213 CM), 3 ML/HR, MACRODRIP WHERE IT WAS REPORTED THERE WAS AN INSTANCE WHERE THE BLOOD PRESSURE (BP) TRACE READING WAS EITHER ABSENT OR INCONSISTENT. THE PATIENT AND THE INVASIVE BP MONITORING CIRCUIT, INCLUDING THE ARTERIAL LINE WERE CHECKED AND NORMAL BP READING WAS CONFIRMED BY NON-INVASIVE MEANS. THE PROBLEM OF ABSENT OR INCONSISTENT BP TRACE WAS RESOLVED BY CHANGING THE TRANSDUCER. THE TRANSDUCER WAS IN USE AND ATTACHED TO AN ARTERIAL CANNULA. THE SYSTEM WAS FLUSHED THROUGH WITH SALINE AND ATTACHED TO A PRESSURIZED BAG OF SALINE AS PER STANDARD PROCEDURE. NO OTHER MEDICATION WAS DELIVERED THROUGH THIS SYSTEM. THE DEVICE IS A SINGLE PRESSURE MONITORING KIT USED TO MEASURE INVASIVE BLOOD PRESSURE THROUGH AN ARTERIAL LINE, THERE IS NO INFUSION AND NO ADMINISTRATION OF MEDICATION/CHEMO INVOLVED. IT IS USED FOR MONITORING PURPOSES. THE PATIENT WAS UNDERGOING SURGERY UNDER GENERAL ANESTHESIA, AND SO VARIOUS OTHER DRUGS WERE DELIVERED VIA THE INTRAVENOUS ROUTE. NO CHEMOTHERAPY WAS INVOLVED. IN THEATRE, THE PRODUCTS ARE USUALLY KEPT WITHIN THE THEATRE STORES OR IN THE ANESTHETIC ROOM. THE NUMBER OF TRANSDUC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19927676 ↗

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