MaxGuard, MaxPlus MP9002-CRecalls & reported problems
BD Switzerland Sàrl · Kink resistant extension set, with clear needleless connector 18 cm (7 in) · Class 2
All models of MaxGuard, MaxPlus (5)
Data updated Oct 16, 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 10885403236761), received between Jul 24, 2019 and Jun 10, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break1
- Difficult or Delayed Separation1
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 10, 2021Difficult to Remove; Difficult or Delayed Separation; Difficult to Remove; Difficult or Delayed Separation
IT WAS REPORTED THAT A 7 IN KINK REST EXTENSION SET W/MAXPLUS WAS DIFFICULT TO DISCONNECT DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "NEEDLESS CONNECTOR WILL NOT DISCONNECT FROM THE EXTENSION SET. UNABLE TO DO PROCEDURE IF IT IS NOT REMOVED. CONNECTOR WAS CHECKED BEFORE BEING USED ON A PATIENT, SO THERE WAS NO IMPACT ON PATIENT CARE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11980358 ↗MalfunctionJul 24, 2019Break; Break
IT WAS REPORTED THAT THE BD MAXPLUS EXTENSION SET BROKE AT AN UNSPECIFIED LOCATION DURING AN "APHERESIS" PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8820460 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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