MaxPlus, MaxGuardRecalls & reported problems across all models
BD Switzerland Sàrl · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 4 models of MaxPlus, MaxGuard by BD Switzerland Sàrl in the FDA's device registry (GUDID). Together they are named in 38 adverse event reports in the FDA's MAUDE database, received between Sep 19, 2018 and Aug 4, 2025 — classified as 38 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (14 reports).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
MaxPlus, MaxGuard recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jun 9, 2021Terminated
A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage.
Z-1995-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported MaxPlus, MaxGuard problems
Device problems
- Leak/Splash14
- Complete Blockage10
- Fluid/Blood Leak7
- Material Separation6
- Defective Component2
- Failure to Prime2
- Separation Problem2
- Disconnection1
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- Insufficient Information10
- No Consequences Or Impact To Patient6
- No Information1
MaxPlus, MaxGuard models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MaxPlus, MaxGuard MP9246-CSet, administration, intravascular1 recall1 report
- MaxPlus, MaxGuard MPXT5302-CSet, administration, intravascular18 reports
- MaxPlus, MaxGuard MX9175Set, administration, intravascular13 reports
- MaxPlus, MaxGuard MP9238-CSet, administration, intravascular6 reports
Recent MaxPlus, MaxGuard adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 4, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT LEAKAGE OCCURRED REPORTED BETWEEN THE MAXZERO CONNECTOR AND THE J-LOOP EXTENSION SET DURING A POWER INJECTION IN CT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22709979 ↗MalfunctionAug 4, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22709978 ↗MalfunctionAug 4, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22709976 ↗MalfunctionAug 4, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22709973 ↗MalfunctionAug 4, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22709972 ↗MalfunctionAug 4, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22709970 ↗MalfunctionAug 4, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22709968 ↗MalfunctionAug 4, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD (B)(6) - 7.5 IN MINIBORE PRESSURE RATED W/T-CONN LEAKED AT A CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER, THERE HAVE BEEN SUBJECTIVE CONCERNS WITH THE PRODUCT IN UP TO 70% OF POWER INJECTION ATTEMPTS. THEY PROVIDED 12 DOCUMENTED EXAMPLES FROM STAFF, ALL INVOLVING CT PROCEDURES WHERE LEAKAGE OCCURRED DURING POWER INJECTION. THE LEAKAGE WAS OBSERVED EITHER AT THE CONNECTION BETWEEN THE CATHETER HUB AND THE J-LOOP EXTENSION SET OR BETWEEN THE J-LOOP AND THE MAXPLUS. IN THIS SPECIFIC CASE, LEAKAGE WAS REPORTED BETWEEN THE INSYTE AG CATHETER HUB AND THE J-LOOP EXTENSION SET DURING A POWER INJECTION IN CT. WHILE NO SPECIFIC INJECTION RATES, GAGE SIZES OR PSI VALUES WERE PROVIDED, THE CUSTOMER CONFIRMED THAT THEY DO NOT EXCEED 325 PSI DURING THESE PROCEDURES. (B)(6) 2025. SHE HAS MENTIONED SHE DOESN¿T HAVE ANY ADDITIONAL INFORMATION.
Patient problems: Insufficient Information
MAUDE report 22709967 ↗MalfunctionAug 4, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22709966 ↗MalfunctionAug 4, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXPLUS PRESSURE RATED EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT LEAKAGE OCCURRED REPORTED BETWEEN THE MAXZERO CONNECTOR AND THE J-LOOP EXTENSION SET DURING A POWER INJECTION IN CT.
Patient problems: Insufficient Information
MAUDE report 22709965 ↗MalfunctionAug 4, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22709624 ↗MalfunctionAug 4, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22708425 ↗MalfunctionAug 4, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXGUARD PRESSURE RATED EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE LEAKAGE OCCURRED BETWEEN THE MAXZERO CONNECTOR AND THE J-LOOP EXTENSION SET DURING A POWER INJECTION IN CT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22708424 ↗MalfunctionOct 22, 2024Material Separation; Separation Problem; Material Separation; Separation Problem
IT WAS REPORTED THAT BD MAXGUARD PRESSURE RATED T-CONNECTOR EXTENSION SET WITH NEEDLELESS CONNECTOR WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: PLEASE SEE BELOW EXTENSION SET WE SPOKE ABOUT EARLIER. AS YOU CAN SEE FROM THE PICTURE BELOW, THE ISSUE WE ARE HAVING IS THE PIECE WITH THE LURE LOCK COUPLER COMING APART FROM THE T CONNECTOR, FAIRLY EASILY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20502632 ↗MalfunctionOct 22, 2024Material Separation; Separation Problem; Material Separation; Separation Problem
IT WAS REPORTED THAT BD MAXGUARD PRESSURE RATED T-CONNECTOR EXTENSION SET WITH NEEDLELESS CONNECTOR WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT THE ISSUE HAVING IS THE PIECE WITH THE LURE LOCK COUPLER COMING APART FROM THE T CONNECTOR, FAIRLY EASILY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20502473 ↗
Other BD Switzerland Sàrl products
- Alaris, SmartSite160 models · 10,227 reports · 8 recalls
- Alaris85 models · 2,797 reports · 10 recalls
- MaxZero47 models · 2,377 reports
- MaxGuard49 models · 780 reports · 11 recalls
- BD PhaSeal23 models · 992 reports · 2 recalls
- MaxPlus18 models · 762 reports · 2 recalls
- BD SmartSite29 models · 568 reports · 4 recalls
- Alaris, SmartSite, Texium12 models · 291 reports · 5 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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