Becker® 27761 (UDI 00763000333577)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000333577), received between Dec 13, 2023 and Feb 26, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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. Nov 1, 2024Open, Classified

   Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).

   Z-0661-2025 · Root cause: Under Investigation by firm · 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.

• MalfunctionFeb 26, 2024Break; Fracture; Break; Fracture

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE HEALTHCARE PROFESSIONAL (HCP) WENT DOWN TO THE EMERGENCY DEPARTMENT TO HELP WITH T HE SETUP OF THE DEVICE WITH THE EMERGENCY ROOM STAFF PER THE REQUEST OF THE STROKE COORDINATOR DUE TO THE FACT THAT THEY WERE ATTEMPTING TO SET UP THE SYSTEM AND IT WAS LEAKING FROM THE PRIMING OF THE SYSTEM FROM THE PROVIDER. THE NEXT THREE THAT WERE CHECKED ALSO HAD CRACKS NEAR THE SAME LOCATIONS. THE LOCATION ON THESE DEVICES WERE NEAR WHERE YOU HOOK-UP THE TRANSDUCER TO THE STOPCOCK. THIS WOULD BE THE STOPCOCK THAT LED TO THE DRAINAGE SYSTEM BAG SYSTEM-THE BOTTOM SIDE OF THE STOPCOCK. ALL THREE DEVICES HAD HAIRLINE CRACKS THROUGH THE TUBING THAT YOU COULD FEEL WITH YOUR FINGER. THE PATIENT DID HAVE A SYSTEM PLACED WITH A DIFFERENT MODEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18776602 ↗
• MalfunctionFeb 8, 2024Break; Fracture; Break; Fracture

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE HEALTHCARE PROFESSIONAL (HCP) WENT DOWN TO THE EMERGENCY DEPARTMENT TO HELP WITH T HE SETUP OF THE DEVICE WITH THE EMERGENCY ROOM STAFF PER THE REQUEST OF THE STROKE COORDINATOR DUE TO THE FACT THAT THEY WERE ATTEMPTING TO SET UP THE SYSTEM AND IT WAS LEAKING FROM THE PRIMING OF THE SYSTEM FROM THE PROVIDER. THE NEXT THREE THAT WERE CHECKED ALSO HAD CRACKS NEAR THE SAME LOCATIONS. THE LOCATION ON THESE DEVICES WERE NEAR WHERE YOU HOOK-UP THE TRANSDUCER TO THE STOPCOCK. THIS WOULD BE THE STOPCOCK THAT LED TO THE DRAINAGE SYSTEM BAG SYSTEM-THE BOTTOM SIDE OF THE STOPCOCK. ALL THREE DEVICES HAD HAIRLINE CRACKS THROUGH THE TUBING THAT YOU COULD FEEL WITH YOUR FINGER. THE PATIENT DID HAVE A SYSTEM PLACED WITH A DIFFERENT MODEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18669340 ↗
• MalfunctionFeb 8, 2024Break; Fracture; Break; Fracture

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE HEALTHCARE PROFESSIONAL (HCP) WENT DOWN TO THE EMERGENCY DEPARTMENT TO HELP WITH T HE SETUP OF THE DEVICE WITH THE EMERGENCY ROOM STAFF PER THE REQUEST OF THE STROKE COORDINATOR DUE TO THE FACT THAT THEY WERE ATTEMPTING TO SET UP THE SYSTEM AND IT WAS LEAKING FROM THE PRIMING OF THE SYSTEM FROM THE PROVIDER. THE NEXT THREE THAT WERE CHECKED ALSO HAD CRACKS NEAR THE SAME LOCATIONS. THE LOCATION ON THESE DEVICES WERE NEAR WHERE YOU HOOK-UP THE TRANSDUCER TO THE STOPCOCK. THIS WOULD BE THE STOPCOCK THAT LED TO THE DRAINAGE SYSTEM BAG SYSTEM-THE BOTTOM SIDE OF THE STOPCOCK. ALL THREE DEVICES HAD HAIRLINE CRACKS THROUGH THE TUBING THAT YOU COULD FEEL WITH YOUR FINGER. THE PATIENT DID HAVE A SYSTEM PLACED WITH A DIFFERENT MODEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18669325 ↗
• MalfunctionFeb 8, 2024Break; Fluid/Blood Leak; Fracture; Break; Fluid/Blood Leak; Fracture

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE HEALTHCARE PROFESSIONAL (HCP) WENT DOWN TO THE EMERGENCY DEPARTMENT TO HELP WITH T HE SETUP OF THE DEVICE WITH THE EMERGENCY ROOM STAFF PER THE REQUEST OF THE STROKE COORDINATOR DUE TO THE FACT THAT THEY WERE ATTEMPTING TO SET UP THE SYSTEM AND IT WAS LEAKING FROM THE PRIMING OF THE SYSTEM FROM THE PROVIDER. THE NEXT THREE THAT WERE CHECKED ALSO HAD CRACKS NEAR THE SAME LOCATIONS. THE LOCATION ON THESE DEVICES WERE NEAR WHERE YOU HOOK-UP THE TRANSDUCER TO THE STOPCOCK. THIS WOULD BE THE STOPCOCK THAT LED TO THE DRAINAGE SYSTEM BAG SYSTEM-THE BOTTOM SIDE OF THE STOPCOCK. ALL THREE DEVICES HAD HAIRLINE CRACKS THROUGH THE TUBING THAT YOU COULD FEEL WITH YOUR FINGER. THE PATIENT DID HAVE A SYSTEM PLACED WITH A DIFFERENT MODEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18669280 ↗
• MalfunctionDec 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE SYSTEM'S STOPCOCK WAS LEAKING. THIS ISSUE WAS DISCOVERED DURING SET UP SO THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18318763 ↗
• MalfunctionDec 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE SYSTEM'S STOPCOCK WAS LEAKING. THIS ISSUE WAS DISCOVERED DURING SET UP SO THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18318734 ↗
• MalfunctionDec 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THE SYSTEM'S STOPCOCK WAS LEAKING. THIS ISSUE WAS DISCOVERED DURING SET UP SO THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18318688 ↗
• MalfunctionDec 13, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT THERE WAS LEAKAGE FROM THE PRECONNECTED STOPCOCK. THE PATIENT WAS NOT IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18318453 ↗