Lifeshield 1235405Recalls & reported problems
ICU Medical, Inc. · LIFESHIELD, Extension Set - 15 Inch, 1.2 Micron Filter, CLAVE Y-Site, Secure Lock · Class 2
All models of Lifeshield (34)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887787005339), received between Aug 22, 2023 and Nov 21, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Air/Gas in Device1
- Material Separation1
- Particulates1
- Therapeutic or Diagnostic Output Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 21, 2025Material Separation; Material Separation
THE EVENT WAS REPORTED VIA MEDSUN UF/IMPORTER REPORT # (B)(4) AND INVOLVED AN EXTENSION SET, 15 INCH, 1.2 MICRON FILTER, CLAVE(TM) Y-SITE, SECURE LOCK. THE DATE OF EVENT WAS AN UNKNOWN DATE IN MAY 2025; 1ST MAY 2025 HAS BEEN USED AS A PLACEHOLDER. THE CUSTOMER REPORTED THAT A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE WAS DISCONNECTED, AND IT WAS FOUND THAT THE TUBING WAS SEVERED AT THE MICRON FILTER SITE. THERE WAS PATIENT INVOLVEMENT, BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23619472 ↗MalfunctionApr 22, 2025Therapeutic or Diagnostic Output Failure; Air/Gas in Device
1.2 MICRON FILTER, CLAVE Y-SITE, SECURE LOCK FILTER FAILED TO FILTER AIR FROM TUBING. TOOK 30 ML TO EXPEL ALL AIR FROM TUBING. 1. THE FILTER WAS BEING PRIMED WITH LIPIDS WHEN THE AIR WAS NOTICED. THERE WAS SUCH A LARGE AMOUNT OF AIR THAT RN ENDED UP DISCONNECTING IT FROM THE LIPIDS AND REPLACING IT WITH A NEW FILTER PRIOR TO PRIMING THE MED TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21881603 ↗MalfunctionAug 22, 2023Particulates; Particulates
THE EVENT INVOLVED AN EXTENSION SET, 15 INCH, 1.2 MICRON FILTER, CLAVE(TM) Y-SITE, SECURE LOCK WHERE IT WAS REPORTED THAT THERE WAS CONDENSATION INSIDE THE TUBE AND THAT IT HAS WHITE RESIDUE. THE EVENT OCCURRED DURING SET UP (ALTHOUGH PATIENT REPORTED THIS HAS HAPPENED PREVIOUSLY AS WELL WITH DATES UNKNOWN). ADDITIONALLY, THE PRODUCT WAS STORED IN A CONTROLLED TEMPERATURE/HUMIDITY WAREHOUSE WITH CONTINUOUS MONITORING, PROTECTED FROM LIGHT. THE MEDICATION INVOLVED WAS A TOTAL PARENTERAL NUTRITION (TPN). THERE WAS NO PATIENT HARM REPORTED AND NO DELAY IN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17596076 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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