Lifeshield 1266028Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10887787005612), received between Jan 24, 2024 and Oct 31, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  EVENT OCCURRED REGARDING EXTENSION SET, 7 INCH, CLAVE CONNECTOR, SECURE LOCK WHERE IT WAS REPORTED THAT THEY HAD TWO INSTANCES WHERE THE TUBING WAS LEAKING/DRIPPING. WHEN THE DEVICE WAS FLUSHED, IT WAS CONNECTING THE TUBING TO THE IV INSIGHT THEN IT BEGAN TO LEAK. THE TUBING THAT CONNECTS TO THE BLUE HUB IS WHERE IT LEAKED IN ALL INSTANCES. THERE WAS REPORTED PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23442396 ↗
• MalfunctionOct 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  EVENT OCCURRED REGARDING EXTENSION SET, 7 INCH, CLAVE CONNECTOR, SECURE LOCK WHERE IT WAS REPORTED THAT THE PATIENT WAS TAKEN TO RADIOLOGY AND WHEN THEY PUSHED THE MEDS THROUGH THE PORT, IT DETACHED AND SPRAYED ALL OVER. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439005 ↗
• MalfunctionSep 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON VARIOUS UNSPECIFIED DATES AND INVOLVED AN EXTENSION SET, 7 INCH, CLAVE CONNECTOR, SECURE LOCK. THE CUSTOMER STATED THAT A LADY WAS NEARING THE END OF HER INFUSION (UNSPECIFIED) WHILE SITTING IN A CHAIR WHEN THE DEVICE RANDOMLY STARTED LEAKING. WITHIN THE LAST MONTH, THE DIRECTOR OF PHARMACY ESTIMATED TO REPLACE ABOUT 10 BECAUSE THEY JUST LEAK CONSTANTLY. THERE WAS PATIENT INVOLVEMENT, DELAY IN TREATMENT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22956691 ↗
• MalfunctionSep 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT GCM RECEIVED A CALL ON (B)(6) 2025 FROM MRS. (B)(6) OF (B)(6) HOSPITAL WITH REGARD TO EXTENSION SET, 7 INCH, CLAVE CONNECTOR, SECURE LOCK WITH ITEM NUMBER (B)(4) AND LOT NUMBER 14034924. THE REPORTER STATED, "OUR DIRECTOR OF PHARMACY WAS DOING SOME IV AND SHE'S HAVING AN ISSUE WITH THE EXTENSION SET 7" AND SHE SAID THAT IT LEAK WHEN YOU PUT IT IN THE IV SITE NO MATTER HOW TIGHT YOU PUT IT". THE MEDICATION INFUSING AT THE TIME OF THE EVENT WAS UNKNOWN. SAMPLE PRODUCT WAS DISCARDED. THERE WAS PATIENT INVOLVEMENT, UNKNOWN ADVERSE EVENT AND UNKNOWN DELAY IN THERAPY. LPALMA (B)(6) 2025

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22956207 ↗
• MalfunctionFeb 11, 2025Material Rupture; Material Rupture

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE(S) AND INVOLVED AN EXTENSION SET, 7 INCH, CLAVE CONNECTOR, SECURE LOCK WHERE THE CUSTOMER REPORTED THAT WHEN PUSHING THE EXTENSION SET INTO HIGH VOLUME, IT CONTRACTS THEN BLOWS AFTER. THERE WAS PATIENT INVOLVEMENT, A DELAY IN THERAPY BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT. THERE WERE 4 OCCURRENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21358669 ↗
• InjuryDec 6, 2024Material Rupture; Material Rupture

  THE EVENT INVOLVED AN EXTENSION SET, 7 INCH, CLAVE CONNECTOR, SECURE LOCK WHERE A REPORT STATED THAT THE TYPE OF EVENT WAS SERIOUS INJURY DUE TO EXPOSURE TO BODY FLUIDS ON PATIENT IN RADIOLOGY BEING GIVEN IV CONTRAST. THE CLAVE 7 INCH EXTENSION SET IN USE IN THE IV LINE BLEW OUT, SPRAYING CONTRAST AND BLOOD AND IT WAS THE THIRD TIME HAPPENED OF THE EXTENSION SET. THERE WAS A PATIENT INVOLVEMENT AND REPORTED A SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20863255 ↗
• MalfunctionMar 18, 2024Material Rupture; Material Rupture

  THE EVENT INVOLVED AN EXT SET 7IN CLV SL WHERE IT WAS REPORTED THAT THE TUBING BURST DURING CONTRAST INJECTION IN CT SCAN. THESE LOOPS WERE USED FOR HIGH PRESSURE INJECTION. THE PRODUCT WAS CONNECTED TO PATIENT AND CT INJECTOR WAS CONNECTED TO LUER LOCK PORT. DUE TO THE EVENT THE SCANS HAD POOR IMAGES DUE TO INSUFFICIENT CONTRAST. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM. TWO DEVICES WERE RETURNED FOR INVESTIGATION. THIS CAPTURES THE SECOND OF TWO DEVICES RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18921908 ↗
• MalfunctionJan 24, 2024Material Rupture; Material Rupture

  THE EVENT INVOLVED AN EXT SET 7IN CLV SL WHERE IT WAS REPORTED THAT THE TUBING BURST DURING CONTRAST INJECTION IN CT SCAN. THESE LOOPS WERE USED FOR HIGH PRESSURE INJECTION. THE PRODUCT WAS CONNECTED TO PATIENT AND CT INJECTOR WAS CONNECTED TO LUER LOCK PORT. DUE TO THE EVENT THE SCANS HAD POOR IMAGES DUE TO INSUFFICIENT CONTRAST. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18572314 ↗
• MalfunctionJan 24, 2024Material Rupture; Material Rupture

  THE EVENT INVOLVED AN EXT SET 7IN CLV SL WHERE IT WAS REPORTED THAT THE TUBING BURST DURING CONTRAST INJECTION IN CT SCAN. THESE LOOPS WERE USED FOR HIGH PRESSURE INJECTION. THE PRODUCT WAS CONNECTED TO PATIENT AND CT INJECTOR WAS CONNECTED TO LUER LOCK PORT. DUE TO THE EVENT THE SCANS HAD POOR IMAGES DUE TO INSUFFICIENT CONTRAST. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18572312 ↗