Lifeshield 1265028Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10887787005490), received between Jun 30, 2023 and Nov 7, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2025Break

  TUBING BROKE OFF THE SIDE OF THE MICROBORE EXTENSION SET PRE-PIERCED T-SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496217 ↗
• MalfunctionMar 13, 2025Crack; Disconnection; Fluid/Blood Leak; Crack; Disconnection; Fluid/Blood Leak

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A NDEHP LS 5.25IN MICROB EXT SET. THE CLAVE ON THE MICROBORE BIFURCATED EXTENSION SET CRACKED, LEAKED AN UNSPECIFIED FLUID, AND POPPED OFF. THERE WAS NO REPORT OF ANY HUMAN HARM ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21600166 ↗
• MalfunctionMar 13, 2025No Flow; No Flow

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A NDEHP LS 5.25IN MICROB EXT SET. THE CUSTOMER REPORTED THAT THE INTRAVENOUS (IV) WAS "NON-INFUSING". THERE WAS NO REPORT OF HUMAN HARM ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21599442 ↗
• MalfunctionMar 12, 2025Material Separation; Material Separation

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A NDEHP LS 5.25IN MICROB EXT SET. THE COMPLAINT RECORD STATED THAT THE CLAVE POPPED OFF. THERE WAS NO REPORT OF ANY HUMAN HARM ASSOCIATED WITH THIS COMPLAINT/EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21590195 ↗
• MalfunctionDec 2, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A MICROBORE EXTENSION SET - 5 INCH, PREPIERCED T-SITE. IT WAS REPORTED THAT ALL PORT SIDES ARE LEAKING. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT OR PATIENT HARM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18253344 ↗
• MalfunctionNov 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT OCCURRED ON UNKNOWN DATE INVOLVING A MICROBORE EXTENSION SET - 5 INCH, PREPIERCED T-SITE WHERE THE CUSTOMER REPORTED THAT THAT THEY ARE HAVING COMPLICATIONS WITH SOME OF THEIR T-PORTS. THEY ARE CONCERNED ABOUT A BATCH THAT SEEMS TO BE MALFUNCTIONING WHICH ARE ALSO USED FOR CHEMOTHERAPY ADMINISTRATIONS. DURING ONE OF THEIR MOST RECENT CHEMOTHERAPY ADMINISTRATIONS, THE CHEMO SOLUTION LEAKED OUT AND WAS COATING THE GLOVES OF THE HANDLER, WHICH BECOMES A HAZARD FOR THEIR STAFF. THEY ARE BEGINNING TO TRACK THE LOT NUMBERS IN HOPES TO CONFIRM WHICH BATCH OF T-PORTS IS BAD, BUT RIGHT NOW THEY ARE SUSPECTING LOT # 11296752. 17 OF THESE T-PORTS HAVE BEEN REMOVED FROM THE WORK FLOOR. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM REPORTED.

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18162214 ↗
• MalfunctionJul 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A FACILITY SUBMITTED A MEDSUN MANDATORY MEDWATCH REPORT (UF/IMPORTER REPORT# 1600820000-2023-8014) REGARDING A MICROBORE EXTENSION SET - 5 INCH, PREPIERCED T-SITE. THE CUSTOMER REPORTED THAT THE T-SITE WAS NOTED TO BE LEAKING INTRAVENOUS (IV) FLUIDS IN THE NEONATAL INTENSIVE CARE UNIT (NICU). THE DEVICE IS A SINGLE-USE DEVICE THAT WAS NOT REPROCESSED AND REUSED ON A PATIENT. THE ORIGINAL INTENDED PROCEDURE IS A CONNECTION SITE FOR PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) AND IV FLUIDS. NO HOLE, CUT, TEARS OR ANY DEFECT NOTED. NO BLOOD LOSS OR BLEED BACK WAS NOTED, AND TUBING WAS REPLACED. THE TUBING WAS SET UP AS A T-CONNECTOR FOR PERIPHERAL ARTERIAL LINE AND THE LEAK OCCURRED AT THE PUNCTURE SITE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM. THIS IS THE THIRD OF THREE REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17395940 ↗
• MalfunctionJul 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A FACILITY SUBMITTED A MEDSUN MANDATORY MEDWATCH REPORT (UF/IMPORTER REPORT# (B)(4)) REGARDING A MICROBORE EXTENSION SET - 5 INCH, PREPIERCED T-SITE. THE CUSTOMER REPORTED THAT THE T-SITE WAS NOTED TO BE LEAKING INTRAVENOUS (IV) FLUIDS IN THE NEONATAL INTENSIVE CARE UNIT (NICU). THE DEVICE IS A SINGLE-USE DEVICE THAT WAS NOT REPROCESSED AND REUSED ON A PATIENT. THE ORIGINAL INTENDED PROCEDURE IS A CONNECTION SITE FOR PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) AND IV FLUIDS. NO HOLE, CUT, TEARS OR ANY DEFECT NOTED. NO BLOOD LOSS OR BLEED BACK WAS NOTED, AND TUBING WAS REPLACED. THE TUBING WAS SET UP AS A T-CONNECTOR FOR PERIPHERAL ARTERIAL LINE AND THE LEAK OCCURRED AT THE PUNCTURE SITE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM. THIS IS THE SECOND OF THREE REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17395917 ↗
• MalfunctionJul 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A FACILITY SUBMITTED A MEDSUN MANDATORY MEDWATCH REPORT (UF/IMPORTER REPORT# (B)(4)) REGARDING A MICROBORE EXTENSION SET - 5 INCH, PREPIERCED T-SITE. THE CUSTOMER REPORTED THAT THE T-SITE WAS NOTED TO BE LEAKING INTRAVENOUS (IV) FLUIDS IN THE NEONATAL INTENSIVE CARE UNIT (NICU). THE DEVICE IS A SINGLE-USE DEVICE THAT WAS NOT REPROCESSED AND REUSED ON A PATIENT. THE ORIGINAL INTENDED PROCEDURE IS A CONNECTION SITE FOR PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) AND IV FLUIDS. NO HOLE, CUT, TEARS OR ANY DEFECT NOTED. NO BLOOD LOSS OR BLEED BACK WAS NOTED, AND TUBING WAS REPLACED. THE TUBING WAS SET UP AS A T-CONNECTOR FOR PERIPHERAL ARTERIAL LINE AND THE LEAK OCCURRED AT THE PUNCTURE SITE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM. THIS IS THE FIRST OF THREE REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17395914 ↗
• MalfunctionJun 30, 2023Fluid/Blood Leak

  T-SITE NOTED TO BE LEAKING IV FLUIDS. THREE DEVICES LEAKED IN TOTAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237143 ↗