MaxZero MZT1003Recalls & reported problems
BD Switzerland Sàrl · Microbore extension set, removeable IV connector, T-injection site 15.5 cm (6 in) · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403471247), received between May 17, 2023 and Apr 4, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Complete Blockage” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Complete Blockage1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 4, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19047109 ↗MalfunctionMay 17, 2023Complete Blockage; Complete Blockage
IT WAS REPORTED WHILE USING BD EXTENSION SET PRESSURE RATED MINIBORE THE TUBING WAS CLOGGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1980-PC: MICROBORE EXTENSION TUBING IS OCCLUDED RIGHT FROM THE PACKAGE. THE PRODUCT IS USELESS IN THIS FORM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16950977 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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