Becker® 27702 (UDI 00721902495687)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00721902495687), received between Jun 24, 2018 and Jul 25, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Disconnection” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2018Disconnection; Detachment of Device or Device Component; Disconnection

  IT WAS REPORTED THE DEVICE DETACHED AT THE DRAINAGE TAP WHERE THE CEREBROSPINAL FLUID DRIPS INTO THE BAG. THE DEVICE COULD NOT BE REASSEMBLED. THE PHYSICIAN REPLACED THE DEVICE WITH ANOTHER ONE, AND THE ISSUE WAS RESOLVED. THE PATIENT WAS FINE, BUT A NEW DEVICE HAD TO BE OPENED UP AND SWITCHED OVER.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7719995 ↗
• MalfunctionJul 25, 2018Disconnection; Detachment of Device or Device Component; Disconnection

  IT WAS REPORTED THE DEVICE DETACHED AT THE DRAINAGE TAP WHERE THE CEREBROSPINAL FLUID DRIPS INTO THE BAG. THE DEVICE COULD NOT BE REASSEMBLED. THE PHYSICIAN REPLACED THE DEVICE WITH ANOTHER ONE, AND THE ISSUE WAS RESOLVED. THE PATIENT WAS FINE, BUT A NEW DEVICE HAD TO BE OPENED UP AND SWITCHED OVER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7719984 ↗
• MalfunctionJul 1, 2018Disconnection; Disconnection

  IT WAS REPORTED THE PRODUCT DISCONNECTED AT THE ¿JOINT.¿ THE PRODUCT WAS TO BE REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7654066 ↗
• MalfunctionJun 24, 2018Disconnection; Disconnection

  IT WAS REPORTED THE TUBING UNDER THE DRIP CHAMBER WHERE IT MEETS THE Y-CONNECTION OF THE INJECTION SITE DID NOT SEEM TO BE GLUED CORRECTLY AND CAME APART. THE PRODUCT WAS REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7632771 ↗

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-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-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
• 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-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-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