Lifeshield 1422928Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10887787006282), received between Nov 16, 2023 and Jun 22, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Particulates” (17 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2026Particulates

  THE EVENT INVOLVED SECONDARY SET, SECURE LOCK, 34 INCH WHICH WAS REPORTED THAT THE HOSPITAL WAS NOTIFIED BY THE DEPARTMENT OF PUBLIC HEALTH OF CONTAMINATED IV TUBING SETS FROM THE MANUFACTURER, ICU MEDICAL. PER THE ALERT RECEIVED. THE CONTAMINATION WAS REPORTED AS SMALL BLACK DOTS ON THE INTERNAL WALLS OF THE DRIP CHAMBERS AND HAS BEEN REPORTED IN NUMEROUS LOTS ACROSS THREE PRODUCT TYPES FROM ICU MEDICAL. IN SOME PRODUCTS, PARTICULATE MATTER APPEARS IN THE LUMEN OR CHAMBER OF THE TUBING. THE PARTICULATE MATTER WAS APPEARED TO BE EMBEDDED IN THE PLASTIC MATERIAL BUT NOT WITHIN THE LUMEN OR CHAMBER. NO ADVERSE EVENTS HAVE BEEN LINKED TO THE PRODUCTS, AND THE BIOLOGICAL NATURE OF THE PARTICULATES REMAINS UNKNOWN. THE EVENT OCCURRED PRIOR TO PATIENT USE AND UPON INSPECTION OF THE PRODUCT. IN ADDITION TO THE BLACK SPECK IT WAS ALSO NOTED THAT THERE WAS SOME WHITE CONTAMINANTS PRESENCE IN THE PRODUCT. THERE WAS NO PATIENT INVOLVEMENT AND PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25580419 ↗
• MalfunctionJun 21, 2026Contamination

  AN EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING THE PRODUCT SECONDARY SET, SECURE LOCK, 34 INCH REPORTING THAT THERE WERE BLACK SPECKS IN THE DRIP CHAMBERS. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25572325 ↗
• MalfunctionJun 18, 2026Contamination; Particulates

  AN EVENT WAS REPORTED INVOLVING SECONDARY SET, SECURE LOCK, 34 INCH IT WAS REPORTED THAT THE PRODUCT WAS INSPECTED, AND SMALL BLACK DOTS WERE OBSERVED IN THE PLASTIC AND A CLOUDY, WHITE, "SOAP-LIKE" SUBSTANCE WAS OBSERVED IN THE PLASTIC. THE IMPACTED PRODUCTS HAVE BEEN SEQUESTERED; THERE WAS A PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25553312 ↗
• MalfunctionJun 18, 2026Particulates

  AN EVENT WAS REPORTED INVOLVING SECONDARY SET, SECURE LOCK, 34 INCH IT WAS REPORTED THAT THE PRODUCT WAS INSPECTED, AND SMALL BLACK DOTS WERE OBSERVED IN THE PLASTIC AND A CLOUDY, WHITE, "SOAP-LIKE" SUBSTANCE WAS OBSERVED IN THE PLASTIC. THERE WAS A PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25553285 ↗
• MalfunctionJun 18, 2026Particulates

  A REPORTED INCIDENT INVOLVING SECONDARY SET SECURE LOCK (34 INCH), SMALL BLACK DOTS WERE OBSERVED WITHIN THE PLASTIC, AND A CLOUDY, WHITE, SOAP-LIKE SUBSTANCE WAS OBSERVED IN THE PLASTIC. THE AFFECTED PRODUCTS WERE SEQUESTERED. THERE WAS PATIENT INVOLVEMENT WITH NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25553263 ↗
• MalfunctionJun 18, 2026Particulates

  THE MEDWATCH MW5188295 WAS RECEIVED ON BEHALF OF A HOSPITAL FACILITY. THE EVENT INVOLVED A SECONDARY SET, SECURE LOCK, 34 INCH WITH ITEM NO 142290490 AND LOT NO 14623286: IT WAS REPORTED THAT THE PRODUCT WAS INSPECTED, AND SMALL BLACK DOTS WERE OBSERVED IN THE PLASTIC ON 11 SECONDARY IV TUBING SETS AND CLOUDY, WHITE, "SOAP-LIKE" SUBSTANCE WAS OBSERVED IN THE PLASTIC OF 30 SECONDARY IV TUBING SETS. THE IMPACTED PRODUCTS HAVE BEEN SEQUESTERED, THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25553078 ↗
• MalfunctionJun 15, 2026Particulates

  THE EVENT INVOLVED A SECONDARY SET, SECURE LOCK, 34 INCH. IT WAS REPORTED AS SMALL BLACK DOTS ON THE INTERNAL WALLS OF THE DRIP CHAMBERS AND HAS BEEN REPORTED IN NUMEROUS LOTS ACROSS THREE PRODUCT TYPES FROM ICU MEDICAL. IN SOME PRODUCTS, PARTICULATE MATTER APPEARS IN THE LUMEN OR CHAMBER OF THE TUBING. THE PARTICULATE MATTER APPEARED TO BE EMBEDDED IN THE PLASTIC MATERIAL BUT NOT WITHIN THE LUMEN OR CHAMBER. NO ADVERSE EVENTS HAVE BEEN LINKED TO THE PRODUCTS AS IT WAS NOTICED PRIOR TO PATIENT USE AND UPON INSPECTION OF THE PRODUCTS, AND THE BIOLOGICAL NATURE OF THE PARTICULATES REMAINS UNKNOWN. THE REPORTED MODEL AND CATALOG NUMBER WAS 1422928 AND IN ADDITION TO THE BLACK SPECK, IT WAS ALSO NOTED THAT THERE WERE SOME WHITE CONTAMINANTS PRESENT IN THE PRODUCT. SAMPLE IMAGES PROVIDED BY THE REPORTER IS AVAILABLE IN THE ATTACHMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25509013 ↗
• MalfunctionJun 15, 2026Particulates

  THE EVENT INVOLVED A SECONDARY SET, SECURE LOCK, 34 INCH WITH LOT NUMBER 14860292 AND LN 142290490: IT WAS REPORTED AS SMALL BLACK DOTS ON THE INTERNAL WALLS OF THE DRIP CHAMBERS AND HAS BEEN REPORTED IN NUMEROUS LOTS ACROSS THREE PRODUCT TYPES FROM ICU MEDICAL. IN SOME PRODUCTS, PARTICULATE MATTER APPEARS IN THE LUMEN OR CHAMBER OF THE TUBING. THE PARTICULATE MATTER APPEARED TO BE EMBEDDED IN THE PLASTIC MATERIAL BUT NOT WITHIN THE LUMEN OR CHAMBER. NO ADVERSE EVENTS HAVE BEEN LINKED TO THE PRODUCTS AS IT WAS NOTICED PRIOR TO PATIENT USE AND UPON INSPECTION OF THE PRODUCTS, AND THE BIOLOGICAL NATURE OF THE PARTICULATES REMAINS UNKNOWN. THE REPORTED MODEL AND CATALOG NUMBER WAS 1422928 AND IN ADDITION TO THE BLACK SPECK, IT WAS ALSO NOTED THAT THERE WERE SOME WHITE CONTAMINANTS PRESENT IN THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25505842 ↗
• MalfunctionJun 15, 2026Particulates

  THE EVENT INVOLVED A SECONDARY SET, SECURE LOCK, 34 INCH. IT WAS REPORTED THAT THE SECONDARY IV TUBING SET HAVE BLACK SPECK OR CONTAMINATION IN THE DRIP CHAMBER. THESE WERE LOCATED BY THE MATERIALS MANAGEMENT TEAM AFTER AN EMAIL ALERT FROM MSDH WARNED OF POSSIBLE CONTAMINATION. THERE WAS NO PATIENT INVOLVEMENT AND HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25501641 ↗
• MalfunctionJun 15, 2026Contamination

  THE EVENT INVOLVED A SECONDARY SET, SECURE LOCK, 34 INCH, AND IT WAS REPORTED THAT THERE IS A BLACK SPECK FOUND IN CHAMBER. THERE WERE NO REPORTED PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25499168 ↗
• MalfunctionJun 12, 2026Particulates

  THE EVENT INVOLVED A SECONDARY SET, SECURE LOCK, 34 INCH THAT THEY HAVE COLLECTED THE TUBING FOUND WITH CONTAMINANTS EMBEDDED IN THE DRIP CHAMBER FROM THE PHARMACY AND THEIR NURSING OPACS MED ROOM AND HAVE REMOVED THEM FROM THEIR STOCK. THE MATERIALS FOUND WERE BLACK, BROWN, AND WHITE. UPON INSPECTION THEY CUT OPEN THE DRIP CHAMBER AND FOUND THE MATERIAL TO ALSO BE EMBEDDED INSIDE THE WALL OF THE DROP CHAMBER. FOR THE WHITE MATERIAL, THEY FOUND THAT MOST OF THEM WERE FREE FLOATING INSIDE THE DRIP CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25485854 ↗
• MalfunctionJun 10, 2026Contamination

  THE EVENT INVOLVED A SECONDARY SET, SECURE LOCK, 34 INCH. IT WAS REPORTED THAT THE 3 SECONDARY IV TUBING SETS HAVE BLACK SPECK OR CONTAMINATION IN THE DRIP CHAMBER. THESE WERE LOCATED BY THE MATERIALS MANAGEMENT TEAM AFTER AN EMAIL ALERT FROM MSDH WARNED OF POSSIBLE CONTAMINATION. THIS EVENT OCCURRED DURING ROUTINE PREVENTIVE MAINTENANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25459373 ↗
• MalfunctionJun 10, 2026Contamination

  AN EVENT OCCURRED ON AN UNSPECIFIED EVENT DATE INVOLVING A PRIMARY SET, PIGGYBACK WAS REPORTED THAT THERE WERE 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 25455343 ↗
• MalfunctionJun 10, 2026Contamination

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A SECONDARY SET, SECURE LOCK, 34 INCH, AND IT WAS REPORTED THAT THE TUBING WAS FOUND WITH CONTAMINANTS EMBEDDED IN THE DRIP CHAMBER FROM THE PHARMACY. THE MATERIALS FOUND WERE BLACK, BROWN, AND WHITE. UPON INSPECTION THEY CUT OPEN THE DRIP CHAMBER AND FOUND THE MATERIAL TO ALSO BE EMBEDDED INSIDE THE WALL OF THE DROP CHAMBER. FOR THE WHITE MATERIAL, THEY FOUND THAT MOST OF THEM WERE FREE FLOATING INSIDE THE DRIP CHAMBER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25455226 ↗
• MalfunctionJun 8, 2026Particulates

  AN EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVED A SECONDARY SET, SECURE LOCK, 34 INCH WHERE IT WAS REPORTED THAT THERE WAS VISIBLE CONTAMINATION OF INTRAVENOUS (IV) TUBING. THE CONTAMINATION IS REPORTED AS SMALL BLACK DOTS ON THE INTERNAL WALLS OF THE DRIP CHAMBERS. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25425610 ↗
• MalfunctionJun 8, 2026Particulates

  AN EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVED A SECONDARY SET, SECURE LOCK, 34 INCH WHERE IT WAS REPORTED THAT THE PRODUCT APPEARED TO HAVE BLACK SPOTS. THERE WAS NO PATIENT INVOLVEMENT OR HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25425574 ↗
• MalfunctionJun 8, 2026Contamination

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A SECONDARY SET, SECURE LOCK, 34 INCH, AND IT WAS REPORTED THAT SMALL BLACK DOTS ON THE INTERNAL WALLS OF THE DRIP CHAMBERS WERE NOTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25425224 ↗
• MalfunctionJun 5, 2026Particulates

  THE INCIDENT WAS REPORTED BY THE (B)(6) DEPARTMENT OF PUBLIC HEALTH. THE EVENT INVOLVED A SECONDARY SET, SECURE LOCK, 34 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 25411470 ↗
• MalfunctionJun 5, 2026Particulates

  THE INCIDENT WAS REPORTED BY THE MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH. THE EVENT INVOLVED A SECONDARY SET, SECURE LOCK, 34 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 25411305 ↗
• MalfunctionJun 5, 2026Particulates

  THE EVENT INVOLVED A SECONDARY SET, SECURE LOCK, 34 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 25410890 ↗
• MalfunctionJun 5, 2026Particulates

  THE INCIDENT WAS REPORTED BY THE MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH. THE EVENT INVOLVED A SECONDARY SET, SECURE LOCK, 34 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 25409970 ↗
• MalfunctionJun 5, 2026Contamination

  THE EVENT INVOLVED A SECONDARY SET, SECURE LOCK, WITH IV SET HANGER, 34 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 25406607 ↗
• MalfunctionJun 4, 2026Particulates

  THE INCIDENT WAS REPORTED BY THE MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH. THE EVENT INVOLVED A SECONDARY SET, SECURE LOCK, 34 INCH WHERE 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 25400147 ↗
• MalfunctionMay 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A COMPLAINT WAS RECEIVED REGARDING A SECONDARY SET, 15 MICRON FILTER IN SIGHT CHAMBER, SECURE LOCK, 86 CM THAT EXPERIENCED LEAKAGE DURING USE. THE REPORTER STATED THAT "RN SPIKED BLOOD TUBING INTO BAG OF BLOOD. RN HUNG BLOOD ON IV TUBING. TUBING CAME OUT IF BAG OF BLOOD HUNG ON POLE AND SPILT ALL OVER PATIENT ROOM AND RN. CHARGE RN INFORMED. MD INFORMED. BLOOD BANK INFORMED AND NEW BLOOD SENT. BLOOD TUBING SUPPLIES AND BLOOD BAG GIVEN TO MANAGER. EVS INFORMED AND ASSISTED RN IN CLEANING OF PATIENT ROOM." THE STATUS OF THE PRODUCT AT THE TIME OF THE EVENT WAS DURING USE ON PATIENT. THE EVENT DATE WAS ON 28-APR-2025 19:08. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22107583 ↗
• MalfunctionAug 7, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT, ON AN UNKNOWN DATE IN JUNE, A SECONDARY SET, SECURE LOCK, 34 INCH GENERATED A LEAK DURING PATIENT USE. THE REPORTER STATED THAT THE SETUP WAS THE PRIMARY SET CONNECTED WITH THE SECONDARY SET AND SPIROS. IT WAS STATED THAT THERE WAS A DISCONNECTION BETWEEN THE SECONDARY SET AND SPIROS WHICH LED TO LEAKAGE. THE LEAK SITE WAS AT THE LEVEL BETWEEN THE SPIROS CONNECTOR AND THE CLAVE CAP. THE EVENT RESULTED IN A CHEMO SPILL. THE CHEMO SPILL WAS CLEANED UP AS PER FACILITY PROTOCOL AND THE HEALTHCARE PROVIDER WORE PERSONAL PROTECTIVE EQUIPMENT/PPE. THE MEDICATION INVOLVED WAS CISPLATIN WITH A DOSAGE OF 38 MG. THERE WAS NO ISSUE ON THE PUMP ONLY THE SET. A SAMPLE IS AVAILABLE FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT AND NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19934910 ↗