MaxGuard MX9059Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885403237584), received between Nov 25, 2019 and Mar 4, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 1, 2022Open, Classified

   Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.

   Z-1757-2022 · Root cause: Error in labeling · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT HAD TWO INSTANCES TODAY OF EXTENSION TUBING BREAKING AT THE CONNECTING. THE TUBING ITSELF IS BREAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24508536 ↗
• MalfunctionMar 12, 2023Material Separation; Component Missing; Material Separation; Component Missing

  IT WAS REPORTED THAT THE BD MAXGUARD EXTENSION SET WITH NEEDLELESS Y-SITE(S) EXPERIENCED MISSING COMPONENT AND COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MX9059: "THIS ONE CAME OUT OF THE PACKAGE WITH NO TUBING ATTACHED ON THE PORT. BUT OTHERS HAVE DISCONNECTED AT THE PORTS ALSO."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16527243 ↗
• MalfunctionJun 21, 2022Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT THERE WERE MULTIPLE OCCURRENCES OF THE BD EXTENSION SET MAXPLUS¿ EXPERIENCING FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS FOUND THAT THERE IS YELLOWING COMPONENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14754884 ↗
• MalfunctionApr 1, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE EXTENSION SET LEAKED AT CONNECTION TO AN UNSPECIFIED MATING DEVICE DURING USE ON A PATIENT. ALTHOUGH THERE WAS A SLIGHT DELAY IN TREATMENT WHILE THE DEVICE WAS STOPPED AND RESTARTED, AS WELL AS FLUIDS THAT LEAKED ONTO THE PATIENT'S CLOTHING, THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT FROM THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9913482 ↗
• MalfunctionDec 5, 2019Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES; "THE BD MAXGUARD EXTENSION SET WITH TWO NEEDLELESS Y-SITES (MX9059) LEAKS AT THE PORTS. THIS HAS HAPPENED WITH MULTIPLE SETS ON DIFFERENT PATIENTS". AN INCOMPLETE DATE OF EVENT OF XX-NOV-2019 WAS PROVIDED. ALTHOUGH REQUESTED, THERE HAS BEEN NO FURTHER PATIENT OR EVENT INFORMATION MADE AVAILABLE TO DATE.

  Patient problems: No Information

  MAUDE report 9417319 ↗
• MalfunctionDec 4, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE EXTENSION TUBING SETS LEAKED AT THE INJECTION PORT. ALTHOUGH REQUESTED, THERE HAS BEEN NO IMPACT TO PATIENT RESPONSE OR ADDITIONAL EVENT INFORMATION MADE AVAILABLE TO DATE. NOTE: WE HAVE BEEN HAVING TROUBLE WITH SOME EXTENSION TUBING LEAKING AT THE INJECTION PORTS. THE PRODUCT IS MAXGUARD EXTENSION SET WITH 2 NEEDLELESS Y-SITES MX9059. I HAVE 2 USED TUBING SETS HERE AND ONE THAT IS LIKELY TO BE FROM THE SAME LOT (19075824). I DON¿T KNOW IF YOU WANT THESE OR NOT, BUT WE THOUGHT YOU¿D LIKE TO KNOW. OUR OR/PACU IS THE ONLY UNIT THAT USES THIS PARTICULAR PRODUCT.

  Patient problems: No Information

  MAUDE report 9412536 ↗
• MalfunctionNov 25, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE EXTENSION TUBING LEAKED AT THE INJECTION PORTS. ALTHOUGH REQUESTED, THERE HAS BEEN NO IMPACT TO PATIENT RESPONSE OR ADDITIONAL EVENT INFORMATION MADE AVAILABLE TO DATE.

  Patient problems: No Information

  MAUDE report 9373466 ↗
• MalfunctionNov 25, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE EXTENSION TUBING SETS LEAKED AT THE INJECTION PORT. ALTHOUGH REQUESTED, THERE HAS BEEN NO IMPACT TO PATIENT RESPONSE OR ADDITIONAL EVENT INFORMATION MADE AVAILABLE TO DATE. NOTE: WE HAVE BEEN HAVING TROUBLE WITH SOME EXTENSION TUBING LEAKING AT THE INJECTION PORTS. THE PRODUCT IS MAXGUARD EXTENSION SET WITH 2 NEEDLELESS Y-SITES MX9059. I HAVE 2 USED TUBING SETS HERE AND ONE THAT IS LIKELY TO BE FROM THE SAME LOT (19075824). I DON¿T KNOW IF YOU WANT THESE OR NOT, BUT WE THOUGHT YOU¿D LIKE TO KNOW. OUR OR/PACU IS THE ONLY UNIT THAT USES THIS PARTICULAR PRODUCT.

  Patient problems: No Information

  MAUDE report 9373451 ↗