Lifeshield 2065428Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887787005858), received between Oct 27, 2020 and Apr 7, 2026 — classified as 3 malfunctions.

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

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Fluid/Blood Leak

  THE EVENT INVOLVED AN EXTENSION SET, 8 INCH, CLAVE(TM) Y-SITE, SECURE LOCK AND IT WAS REPORTED THAT THERE WAS A POSSIBLE LEAK IN THE PRODUCT. THERE HAD BEEN MULTIPLE INCIDENCES OF SALINE SPRAYING OUT OF THEM, AND THIS CONTINUED EVEN AFTER DOUBLE-CHECKING ALL THE CONNECTIONS. THERE WAS 2 MINUTES DELAYED IN THERAPY. THE PATIENT WAS FINE. THE CONCERN WAS DIRECTED TO THE NURSE WHO ADMINISTERED THE MEDICATION, PARTICULARLY THE CHEMOTHERAPY MEDICATION. THERE WAS PATIENT INVOLVEMENT, AND NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24797550 ↗
• MalfunctionDec 7, 2020Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  A MEDSUN MANDATORY MEDWATCH REPORT (UF/IMPORTER # (B)(4)) WAS RECEIVED FROM THE USER FACILITY STATING, ¿¿FROM STAFF: RN INTO TO TURN PATIENT WITH ANOTHER RN. PRIMARY RN CHECKED LINES TO MAKE SURE THERE WAS ENOUGH SLACK BEFORE TURNING WHICH THERE WAS. WHEN TURNING THE PATIENT, PRIMARY RN NOTICED BLOOD ON THE BED AND FOUND THE IV CONNECTION TUBING TO BE DISLODGE FROM THE HUB WITHOUT ANY TENSION ON THE TUBING. EPINEPHRINE WAS RUNNING THROUGH THE TUBING AT THE TIME, RN QUICKLY SWITCH EPINEPHRINE TO PICC LINE. RN NOTICES PRESSURE DROP TO 99 SYSTOLIC FOR A SHORT PERIOD OF TIME THEN BP RETURNED TO PREVIOUS SYSTOLIC NUMBER OF 120-130 WITHIN AN EXPECTED TIMEFRAME¿ ADDITIONALLY, THE CUSTOMER STATED THAT IT IS UNKNOWN IF THERE WERE ANY ISSUES WITH THE SET-UP/PRIMING BECAUSE IT OCCURRED IN THE OPERATING ROOM ON (B)(6) 2020. THE SET UP WAS CONNECTED TO A CENTRAL LINE. THE RN NOTICED THE BREAKAGE WHEN HE SAW BLOOD ON THE WHITE SHEETS AND IT HAPPENED DURING ROUTINE TURNING. THE CUSTOMER PROVIDED A PHOTO AND INDICATED THAT THE BREAK OCCURRED ON THE TUBING NEAR THE FEMALE ADAPTER. THE SET WAS REMOVED AND IT WAS NOT REPLACED WITH THE SAME PRODUCT. NO FURTHER ISSUES WERE REPORTED. THERE WAS PATIENT I

  Patient problems: Blood Loss; Low Blood Pressure/ Hypotension; No Consequences Or Impact To Patient

  MAUDE report 10960942 ↗
• MalfunctionOct 27, 2020Device Dislodged or Dislocated

  FROM STAFF: RN INTO TO TURN PATIENT WITH ANOTHER RN. PRIMARY RN CHECKED LINES TO MAKE SURE THERE WAS ENOUGH SLACK BEFORE TURNING WHICH THERE WAS. WHEN TURNING THE PATIENT, PRIMARY RN NOTICED BLOOD ON THE BED AND FOUND THE IV CONNECTION TUBING TO BE DISLODGED FROM THE HUB WITHOUT ANY TENSION ON THE TUBING. EPINEPHRINE WAS RUNNING THROUGH THE TUBING AT THE TIME, RN QUICKLY SWITCHED EPINEPHRINE TO PICC LINE. RN NOTICED PRESSURE DROP TO 99 SYSTOLIC FOR A SHORT PERIOD OF TIME THEN BP RETURNED TO PREVIOUS SYSTOLIC NUMBER OF 120-130 WITHIN AN EXPECTED TIMEFRAME.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 10739859 ↗