MaxGuard, MaxPlus MP9251-CRecalls & reported problems
BD Switzerland Sàrl · 6-IN MINIBORE SET W/ MAXPLUS Y-SITE · Class 2
All models of MaxGuard, MaxPlus (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885403237188), received between May 18, 2019 and Jul 18, 2019 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Crack” (4 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
Device problems
- Crack4
- Break3
- Fluid/Blood Leak2
- Fracture1
Patient problems
- No Consequences Or Impact To Patient5
- No Information3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 18, 2019Crack; Crack
IT WAS REPORTED THAT WHEN THE USER DISCONNECTED THE MAXPLUS EXTENSION SET FROM THE IV SITE, THE CLEAR CONNECTION CRACKED OFF FROM THE SET. ALTHOUGH REQUESTED, NO FURTHER DETAILS WERE PROVIDED BY THE CUSTOMER FOR THIS EVENT.
Patient problems: No Consequences Or Impact To Patient; No Information
MAUDE report 8801300 ↗MalfunctionJul 11, 2019Crack; Crack
IT WAS REPORTED THAT MAXPLUS EXTENSION WAS ATTACHED TO NEUTRACLEAR, UPON CLOSER OBSERVATION THE RN NOTICED THAT THE EXTENSION SET WAS CRACKED AT THE MALE LUER WHEN ATTACHED TO A NICU PATIENT. ALTHOUGH REQUESTED, NO FURTHER DETAILS WERE PROVIDED BY THE CUSTOMER FOR THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8782602 ↗MalfunctionJul 10, 2019Break; Break
IT WAS REPORTED THAT THERE WAS A BREAK AT THE MALE LUER ON THE MAXPLUS AND NEUTRACLEAR VALVES STICK DOWN, WHEN ATTACHED TO A NICU PATIENT. ALTHOUGH REQUESTED, THERE IS NO ADDITIONAL PATIENT OR EVENT INFORMATION AVAILABLE.
Patient problems: No Information; No Known Impact Or Consequence To Patient
MAUDE report 8778743 ↗MalfunctionJul 9, 2019Crack; Crack
IT WAS REPORTED THAT MAXPLUS EXTENSION WAS ATTACHED TO NEUTRACLEAR, UPON CLOSER OBSERVATION THE RN NOTICED THAT THE EXTENSION SET WAS CRACKED AT THE MALE LUER WHEN ATTACHED TO A NICU PATIENT. ALTHOUGH REQUESTED, NO FURTHER DETAILS WERE PROVIDED BY THE CUSTOMER FOR THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8774071 ↗MalfunctionJul 5, 2019Crack; Crack
IT WAS REPORTED THAT THE USER NOTICED A MAXPLUS EXTENSION SET CRACKED AT THE MALE LUER. THE EVENT OCCURRED IN THE NICU.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8764722 ↗MalfunctionJun 21, 2019Break; Fluid/Blood Leak; Break; Fluid/Blood Leak
IT WAS REPORTED THAT THE USER NOTICED BLOOD SATURATED PATIENT CLOTHING, UPON CLOSER OBSERVATION A MINIBORE EXTENSION SET HUB BROKE OFF INTO THE MAXPLUS CONNECTOR WHEN ATTACHED TO A BROVIAC CATHETER. THE USER STATED THAT IT WAS UNKNOWN WHICH SET BROKE INITIALLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8725397 ↗MalfunctionMay 18, 2019Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture
IT WAS REPORTED THAT THE TUBING WAS CRACKED AND LEAKING AT THE CONNECTION SITE. DURING DISCONNECTION OF THE PRODUCT, THE TIP OF THE SET BROKE OFF AND REMAINED IN THE CONNECTION SITE OF THE MATING PRODUCT.
Patient problems: No Information
MAUDE report 8622203 ↗
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- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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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