Lifeshield 1266228Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10887787005643), received between Oct 7, 2024 and Jun 29, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Particulates” (19 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2026Particulates

  A REPORTED INCIDENT INVOLVING A PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 2 CLAVE Y-SITES, SECURE LOCK, 100 INCH HAVE BLACK DOTS NOTED IN HUNDREDS OF ICU MEDICAL IV TUBING. THERE WERE NO REPORTED PATIENT INVOLVEMENT AND HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25659416 ↗
• MalfunctionJun 22, 2026Crack; No Flow

  A EVENT INVOLVED A PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 2 CLAVE Y-SITES, SECURE LOCK, 100 INCH WAS REPORTED THAT THE BLUE Y-SITE CLOSEST TO THE HUB WAS CRACKED AND BACK FLOWED BLOOD. THERE WERE A PATIENT INVOLVEMENT AND NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25576634 ↗
• MalfunctionJun 12, 2026Particulates

  THE EVENT INVOLVED A PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 2 CLAVE Y-SITES, SECURE LOCK, 100 INCH. IT WAS REPORTED THAT BLACK SPEC ISN¿T ALWAYS IMBEDDED INTO THE MATERIAL IN THE CHAMBER. THE BLACK SPEC WAS EASILY WIPED AWAY WITH A FINGER, SO THIS IS NOT EMBEDDED INTO THE MATERIAL. THEY WERE ABLE TO WIPE IT OFF AFTER CUTTING THE CHAMBER OPEN. IF THEY SEE A BLACK SPEC, IT IS COMING BACK AS A RETURN. WHEN THEIR TEAM FOUND THE PRODUCT AND CUT IT OPEN 2 OF THEM WERE EASILY WIPED OFF. THERE WERE NO REPORTED PATIENT INVOLVEMENT AND HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25485846 ↗
• MalfunctionJun 12, 2026Particulates

  THE EVENT INVOLVED A PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 2 CLAVE Y-SITES, SECURE LOCK, 100 INCH: IT WAS REPORTED THAT BLACK SPEC ISN¿T ALWAYS IMBEDDED INTO THE MATERIAL IN THE CHAMBER. THE BLACK SPEC WAS EASILY WIPED AWAY WITH A FINGER, SO THIS IS NOT EMBEDDED INTO THE MATERIAL. THEY WERE ABLE TO WIPE IT OFF AFTER CUTTING THE CHAMBER OPEN. IF THEY SEE A BLACK SPEC, IT IS COMING BACK AS A RETURN. WHEN THEIR TEAM FOUND THE PRODUCT AND CUT IT OPEN 2 OF THEM WERE EASILY WIPED OFF. THERE WERE NO REPORTED PATIENT INVOLVEMENT AND HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25485812 ↗
• MalfunctionJun 12, 2026Particulates

  THE EVENT INVOLVED A PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 2 CLAVE Y-SITES, SECURE LOCK, 100 INCH. IT WAS REPORTED THAT BLACK SPEC ISN¿T ALWAYS IMBEDDED INTO THE MATERIAL IN THE CHAMBER. THE BLACK SPEC WAS EASILY WIPED AWAY WITH A FINGER, SO THIS IS NOT EMBEDDED INTO THE MATERIAL. THEY WERE ABLE TO WIPE IT OFF AFTER CUTTING THE CHAMBER OPEN. IF THEY SEE A BLACK SPEC, IT IS COMING BACK AS A RETURN. WHEN THEIR TEAM FOUND THE PRODUCT AND CUT IT OPEN 2 OF THEM WERE EASILY WIPED OFF. THERE WERE NO REPORTED PATIENT INVOLVEMENT AND HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25485581 ↗
• MalfunctionJun 10, 2026Particulates

  THE EVENT INVOLVED A PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 2 CLAVE Y-SITES, SECURE LOCK, 100 INCH THAT DURING SET UP THERE WAS A PARTICULATE IN TUBING. THERE WERE NO PATIENT INVOLVEMENT AND PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25460467 ↗
• MalfunctionJun 10, 2026Particulates

  THE EVENT INVOLVED A PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 2 CLAVE Y-SITES, SECURE LOCK, 100 INCH THAT BLACK SPEC ISN¿T ALWAYS IMBEDDED INTO THE MATERIAL IN THE CHAMBER. THE BLACK SPEC WAS EASILY WIPED AWAY WITH A FINGER, SO THIS IS NOT EMBEDDED INTO THE MATERIAL. THEY WERE ABLE TO WIPE IT OFF AFTER CUTTING THE CHAMBER OPEN. IF THEY SEE A BLACK SPEC, IT IS COMING BACK AS A RETURN. WHEN THEIR TEAM FOUND THE PRODUCT AND CUT IT OPEN 2 OF THEM WERE EASILY WIPED OFF. THERE WERE NO REPORTED PATIENT INVOLVEMENT AND HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25460114 ↗
• MalfunctionJun 10, 2026Particulates

  THE INCIDENT WAS REPORTED BEHALF OF CUSTOMER FACILITY THE EVENT INVOLVED A PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 2 CLAVE Y-SITES, SECURE LOCK, 100 INCH IT WAS REPORTED THAT BLACK SPEC ISN¿T ALWAYS IMBEDDED INTO THE MATERIAL IN THE CHAMBER. THE BLACK SPEC WAS EASILY WIPED AWAY WITH A FINGER, SO THIS IS NOT EMBEDDED INTO THE MATERIAL. THEY WERE ABLE TO WIPE IT OFF AFTER CUTTING THE CHAMBER OPEN. IF THEY SEE A BLACK SPEC, IT IS COMING BACK AS A RETURN. WHEN THEIR TEAM FOUND THE PRODUCT AND CUT IT OPEN 2 OF THEM WERE EASILY WIPED OFF. THERE WERE NO REPORTED PATIENT INVOLVEMENT AND HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25459913 ↗
• MalfunctionJun 10, 2026Contamination

  AN EVENT OCCURRED ON AN UNSPECIFIED EVENT DATE INVOLVING A PRIMARY SET, PIGGYBACK REPORTED THAT THE DEVICE FOUND WITH BLACK SPECKS IN DRIP CHAMBER. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25455232 ↗
• MalfunctionJun 9, 2026Contamination

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 2 CLAVE Y-SITES, SECURE LOCK, 100 INCH, AND IT WAS REPORTED THAT THERE IS SOME BLACK SPOTS AND DEBRIS FOUND IN THE DRIP CHAMBER. THERE WAS NO REPORTED PATIENT INVOLVEMENT, AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25441011 ↗
• MalfunctionJun 8, 2026Particulates

  THE EVENT INVOLVED A PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 2 CLAVE Y-SITES, SECURE LOCK THAT AFTER REVIEWING THE PRODUCTS ON HAND IT WAS DISCOVERED THAT THERE WAS A CONTAMINATION HAVING SOME SPOTS AND CONDENSATION IN THE DRIP CHAMBER. THERE WERE NO PATIENT INVOLVEMENT AND HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25436699 ↗
• MalfunctionJun 8, 2026Particulates

  AN EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 2 CLAVE Y-SITES, SECURE LOCK, 100 INCH, REPORTING THAT MOBILE AND IMMOBILE DEBRIS WAS OBSERVED FLOATING IN THE DRIP CHAMBER OF THE IV TUBING AFTER SPIKING A NORMAL SALINE BAG. THE BAG AND TUBING WERE SEQUESTERED, AND THE SUPPLY CHAIN WAS NOTIFIED. THE CONTAMINANT IS SUSPECTED TO HAVE ORIGINATED FROM THE IV TUBING. THE AFFECTED LOT WAS REMOVED FROM USE IN THE ED. IN MOST CASES, A SINGLE BROWN OR BLACK SPOT WAS OBSERVED IN THE SAME AREA OF THE DRIP CHAMBER. IT WAS NOTED THAT IN SOME INSTANCES THE SPECK APPEARED BLACK, WHILE IN OTHERS IT APPEARED BROWN. IN BOTH CASES, THE SPECIMEN APPEARED TO BE EMBEDDED IN THE PLASTIC OF THE DRIP CHAMBER IN NEARLY IDENTICAL LOCATIONS. THE DRIP CHAMBER WAS OPENED TO ALLOW ACCESS TO THE SPECK. ATTEMPTS WERE MADE TO REMOVE THE SPECK; HOWEVER, IT COULD NOT BE REMOVED. EVEN WITH AGGRESSIVE SCRAPING USING A SCALPEL, THE SPECK REMAINED EMBEDDED IN THE INNER PLASTIC SURFACE OF THE DRIP CHAMBER. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25436367 ↗
• MalfunctionJun 5, 2026Particulates

  THE INCIDENT WAS REPORTED BY THE MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH. THE EVENT INVOLVED A PRIMARY SET PIGGYBACK WITH BACKCHECK VALVE, 2 CLAVE Y-SITES, SECURE LOCK, 100 INCH WHERE IT WAS REPORTED THAT THERE WAS SMALL BLACK DOTS ON THE INTERNAL WALLS OF THE DRIP CHAMBERS. THERE WERE NO REPORTED PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25415052 ↗
• MalfunctionJun 5, 2026Particulates

  THE INCIDENT WAS REPORTED BY THE (B)(6). THE EVENT INVOLVED A PRIMARY SET PIGGYBACK WITH BACKCHECK VALVE, 2 CLAVE Y-SITES, SECURE LOCK, 100 INCH WHERE IT WAS REPORTED THAT THERE WAS SMALL BLACK DOTS ON THE INTERNAL WALLS OF THE DRIP CHAMBERS. THERE WERE NO REPORTED PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25414529 ↗
• MalfunctionJun 5, 2026Particulates

  THE INCIDENT WAS REPORTED BY THE (B)(6) DEPARTMENT OF PUBLIC HEALTH. THE EVENT INVOLVED A PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 2 CLAVE Y-SITES, SECURE LOCK, 100 INCH, WHERE SMALL BLACK DOTS WERE OBSERVED ON THE INTERNAL WALLS OF THE DRIP CHAMBERS THERE WERE NO REPORTED PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25412612 ↗
• MalfunctionJun 5, 2026Particulates

  THE EVENT INVOLVED A PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 2 CLAVE Y-SITES, SECURE LOCK, 100 INCH THERE WAS SMALL BLACK DOTS ON THE INTERNAL WALLS OF THE DRIP CHAMBERS. THERE WERE NO REPORTED PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25411215 ↗
• MalfunctionJun 5, 2026Particulates

  THE INCIDENT WAS REPORTED BY THE MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH. THE EVENT INVOLVED REGARDING A PRIMARY SET PIGGYBACK WITH BACKCHECK VALVE, 2 CLAVE Y-SITES, SECURE LOCK, 100 INCH THAT THERE WERE SMALL BLACK DOTS ON THE INTERNAL WALLS OF THE DRIP CHAMBERS. THERE WERE NO REPORTED PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25411025 ↗
• MalfunctionJun 5, 2026Particulates

  THE INCIDENT WAS REPORTED BY THE MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH. THE EVENT INVOLVED A PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 2 CLAVE Y-SITES, SECURE LOCK, 100 INCH, WHERE SMALL BLACK DOTS WERE OBSERVED ON THE INTERNAL WALLS OF THE DRIP CHAMBERS. THERE WAS NO PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25409507 ↗
• MalfunctionJun 5, 2026Particulates

  THE INCIDENT WAS REPORTED BY THE MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH. THE EVENT INVOLVED A PRIMARY SET PIGGYBACK WITH BACKCHECK VALVE, 2 CLAVE Y-SITES, SECURE LOCK, 100 INCH THAT THERE WERE SMALL BLACK DOTS ON THE INTERNAL WALLS OF THE DRIP CHAMBERS. THERE WERE NO REPORTED PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25408191 ↗
• MalfunctionJun 5, 2026Contamination

  THE EVENT INVOLVED A PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 2 CLAVE Y-SITES, SECURE LOCK, 100 INCH, AND IT WAS REPORTED THERE WAS SMALL BLACK DOTS ON THE INTERNAL WALLS OF THE DRIP CHAMBERS. THERE WERE NO REPORTED PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25406628 ↗
• MalfunctionJun 5, 2026Contamination

  THE EVENT INVOLVED A PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 2 CLAVE Y-SITES, SECURE LOCK, 100 INCH, AND IT WAS REPORTED THERE WAS SMALL BLACK DOTS ON THE INTERNAL WALLS OF THE DRIP CHAMBERS. THERE WERE NO REPORTED PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25406587 ↗
• MalfunctionJun 4, 2026Particulates

  THE INCIDENT WAS REPORTED BY THE MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH. THE EVENT INVOLVED A PRIMARY SET PIGGYBACK WITH BACKCHECK VALVE, 2 CLAVE Y-SITES, SECURE LOCK, 100 INCH WHERE IT WAS REPORTED THAT THERE WAS SMALL BLACK DOTS ON THE INTERNAL WALLS OF THE DRIP CHAMBERS. THERE WERE NO REPORTED PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25399367 ↗
• MalfunctionJun 2, 2026Contamination

  THE EVENT INVOLVED A PRIMARY PLUM ADMINISTRATION SET, AND IT WAS REPORTED THAT THERE WERE BLACK SPOTS OR DEFECTS WITH THE TUBING. THERE WERE NO REPORTED PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25356983 ↗
• MalfunctionMay 26, 2026Particulates

  BLACK SPOTS AND DEBRIS WERE REPORTED IN THE DRIP CHAMBER OF THE FOLLOWING DEVICE: PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 2 CLAVE Y-SITES, SECURE LOCK, 100 INCH. THERE WAS NO PATIENT INVOLVEMENT, HARM OR ANY DELAY IN PATIENT CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25285581 ↗
• MalfunctionMay 26, 2026Particulates

  BLACK SPOTS AND DEBRIS WERE REPORTED IN THE DRIP CHAMBER OF A PRIMARY SET, PIGGYBACK WITH BACKCHECK VALVE, 2 CLAVE Y-SITES, SECURE LOCK, 100 INCH. THERE WAS NO PATIENT INVOLVEMENT AND HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25284508 ↗