Lifeshield 1243502Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10887787005360), received between Sep 29, 2023 and Jun 11, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2026Fluid/Blood Leak; No Flow

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A PRIMARY Y-TYPE BLOOD SET, 200 MICRON FILTER, BULB PUMP, CLAVE Y-SITE, SECURE LOCK, 80 INCHES, AND IT WAS REPORTED THAT THERE WERE ISSUES WITH THE TUBING, WITH BLOOD BACKING UP INTO THE LINES AND LEAKING FROM THE PORTS. THE BULB BEING VERY HARD TO SQUEEZE WHEN ADMINISTERING A BOLUS. THERE WERE PATIENT INVOLVEMENT AND PATIENT HARM. THE EVENT OCCURRED DURING ADMINISTRATION OF INTRAVENOUS (IV) THERAPY AND MOST OF THE EVENTS ARE NOTED IN POST-ANESTHESIA CARE UNIT (PACU). THE BLOOD BACK FLOWED INTO THE TUBING AND IN SOME CASES TO THE BULB AND BLOOD HAD PASSED THE STOPCOCKS. THERE WAS A DELAY IN THERAPY IN WHICH PATIENT WAS HYPOTENSIVE REQUIRING FLUID BOLUS IN PACU. ONCE THE TUBING WAS EXCHANGED, THE HYPOTENSION WAS CORRECTED, AND THE PATIENT WAS ABLE TO BE DISCHARGED HOME. THE IV FLUID IS INFUSED VIA PERIPHERAL LINE PLACED ON THE DAY OF SURGERY. PACU IV FLUID IS INFUSED AT A RATE OF 125ML PER HOUR AND PATIENT HAS RECEIVED 3 DOSES OF EPHEDRINE IN PACU.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 25466241 ↗
• MalfunctionAug 18, 2025No Flow; No Flow

  THE EVENT INVOLVED A PRIMARY Y-TYPE BLOOD SET, 200 MICRON FILTER, BULB PUMP, CLAVE Y-SITE, SECURE LOCK, 80 INCH DEVICE AND IT OCCURRED ON AN UNSPECIFIED DATE. THIS DEVICE REPORTEDLY BACKED UP WITH BLOOD AND WOULD NOT RUN FLUIDS AT ALL WHEN TRYING TO INFUSE A PATIENT IN THE ANESTHESIA DEPARTMENT. THE INCIDENCES NEEDED TO QUICKLY INFUSE UNSPECIFIED FLUIDS BUT HAVE BEEN UNABLE TO DO SO SAFELY OR EFFECTIVELY. MULTIPLE TROUBLESHOOTING TECHNIQUES WERE ATTEMPTED WITH NO IMPROVEMENT. THIS ISSUE WITH THE TUBING HAS BEEN REOCCURRING AND IT CAUSED A DELAY IN THERAPY BECAUSE THEY WERE UNABLE TO INFUSE FLUIDS, ETC. AT AN IDEAL RATE. THERE WAS NO REPORT OF ANY HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22835159 ↗
• MalfunctionAug 18, 2025No Flow; No Flow

  EVENT OCCURRED ON AN UNKNOWN DATE REGARDING A PRIMARY Y-TYPE BLOOD SET, 200 MICRON FILTER, BULB PUMP, CLAVE Y-SITE, SECURE LOCK, 80 INCH WHERE THEY REPORTED THAT THE TUBING REPEATEDLY BACKS UP WITH BLOOD AND WILL NOT RUN FLUIDS AT AN IDEAL RATE WHEN TRYING TO INFUSE WITH A PATIENT. THIS HAS BEEN A REOCCURRING INCIDENT, AND WHICH NEEDED TO QUICKLY INFUSE FLUIDS BUT HAVE BEEN UNABLE TO DO SO SAFELY OR EFFECTIVELY. MULTIPLE TROUBLESHOOTING TECHNIQUES WERE ATTEMPTED WITH NO IMPROVEMENT. THE ISSUE OCCURRED AT LABOR AND DELIVERY DEPARTMENT. THERE WAS PATIENT INVOLVEMENT, DELAY IN THERAPY AND UNKNOWN ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22829961 ↗
• MalfunctionMay 20, 2025Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  THE EVENT INVOLVED A PRIMARY Y-TYPE BLOOD SET, 200 MICRON FILTER, BULB PUMP, CLAVE Y-SITE, SECURE LOCK, 80 INCH WHERE IT WAS REPORTED DURING A PROCEDURE WHILE ADMINISTERING LACTATED RINGER'S, THE TUBING SHOT OUT OF THE BULB AND SOLUTION WENT ALL OVER THE PATIENT. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22055514 ↗
• MalfunctionJan 14, 2025Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  THE EVENT INVOLVED A PRIMARY Y-TYPE BLOOD SET, 200 MICRON FILTER, BULB PUMP, CLAVE Y-SITE, SECURE LOCK, 80 INCH WHERE IT WAS REPORTED THAT A SET OF BLOOD TUBING CAME APART AND LEAKED BELOW THE FILTER WHILE ADMINISTERING BLOOD TO A PATIENT. THERE WAS PATIENT INVOLVEMENT, POTENTIAL CONTAMINATION OF IV FLUIDS, AND THERE WAS A DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21151036 ↗
• MalfunctionJan 3, 2025Separation Problem; Separation Problem

  THE EVENT INVOLVED A PRIMARY Y-TYPE BLOOD SET, 200 MICRON FILTER, BULB PUMP, CLAVE Y-SITE, SECURE LOCK, 80 INCH WHERE THE CUSTOMER REPORTED THAT THE DEVICE SEPARATED DURING PATIENT INFUSION. IT WAS REPORTED THAT WHEN THEY ATTEMPT TO PURGE THE AIR IN THE BULB BACK TOWARDS THE FILTER, THE TUBING CAME APART. 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 21072192 ↗
• MalfunctionSep 29, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PRIMARY Y-TYPE BLOOD SET, 200 MICRON FILTER, BULB PUMP, CLAVE Y-SITE, SECURE LOCK, 80 INCH GENERATED A LEAK BETWEEN THE CONNECTION AND THE RANGER WARMING CASSETTE. SHE ADDED THAT THE LEAK WAS NOTED AFTER THE CONNECTION WAS CLEANED AND TIGHTENED WITHIN THE FIRST 5 MINUTES OF THE INFUSION. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17849050 ↗