Becker® 27779 (UDI 00885074046891)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885074046891), received between Mar 10, 2022 and Feb 27, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

6 other recalls cover devices cleared under the same FDA submission (K984053); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT "ONE PATIENT WAS IN ICU AND THE OTHER PATIENT WAS IN NEURO HDU."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18787807 ↗
• MalfunctionFeb 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT "ONE PATIENT WAS IN ICU AND THE OTHER PATIENT WAS IN NEURO HDU."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18787799 ↗
• InjuryMar 10, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING SYSTEM. IT WAS REPORTED THAT, POST-OPERATIVELY, THE CUSTOMER SAW "AFTER MAKING CONTROL AFTER" 1 HOUR OF LIQUID DRAINING AT THE ICU, THAT NO LIQUID HAD BEEN FILLING UP THE RESERVOIR, BUT INSTEAD IN THE ATTACHED DRAINAGE BAG. EVEN AFTER ADJUSTING ALL THE CLAMPS BELOW THE RESERVOIR, THE LIQUID WAS JUST RAN DIRECTLY INTO THE DRAINAGE BAG. SEVERAL ADJUSTMENTS ON THE LINE WITH THE CLAMPS WERE MADE, BUT NOTHING HELPED TO COLLECT THE LIQUID IN THE RESERVOIR, JUST IN THE DRAINAGE BAG. THE CUSTOMER SWITCHED TO A NEW EXTERNAL DRAINAGE AND MONITORING SYSTEM. THERE COMMENTS FROM THE HEALTHCARE PROFESSIONALS WAS THAT THIS SYSTEM WAS NOT WORKING CORRECTLY. THERE WAS NO REPORTED DELAY TO THE PROCEDURE. THERE WAS NO REPORTED IMPACT TO THE PATIENT. IT WAS NOTED THAT THE PATIENT HAD A SHUNT IMPLANT (NOT VERIFIED IF IT IS A MEDTRONIC SHUNT) WHICH IS UNDERGOING ADVANCED MONITORING OF LIQUID DRAINAGE FROM THE HEAD. THE PATIENT WAS SUSPECTED TO HAVE ENCEPHALITIS OR A MALFUNCTION OF THE SHUNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13721843 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K984053. One submission often covers many models, so check the product and lot details in each record.

• Z-2412-2023 · Jun 28, 2023 · Open, Classified
  Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only
• Z-1922-2014 · Jun 9, 2014 · Terminated
  Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, Catalog No. 46915. Intended to allow drainage and measurement of cerebrosp
• Z-1923-2014 · Jun 9, 2014 · Terminated
  Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, Catalog No. 46916. Intended to allow drainage and measurement of cerebrosp
• Z-1921-2014 · Jun 9, 2014 · Terminated
  Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Catalog No. 46914. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and o
• Z-1924-2014 · Jun 9, 2014 · Terminated
  Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, Catalog No. 46917. Intended to allow drainage and measurement of cerebrospinal
• Z-1920-2014 · Jun 9, 2014 · Terminated
  Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Catalog No. 46913. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and o