Becker® 46128 (UDI 00673978228754)Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00673978228754), received between Nov 22, 2016 and Mar 5, 2024 — classified as 32 malfunctions.

The most frequently reported specific device problem is “Disconnection” (10 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2024Break; Fracture; Mechanical Jam; Break; Fracture; Mechanical Jam

  MEDTRONIC RECEIVED INFORMATION REGARDING AN EXTERNAL DRAINAGE AND MONITORING. IT WAS REPORTED THAT THE NURSE WAS HAVING ISSUES WITH CHANGING THE BAG ONCE FULL ON THE SYSTEM. IT WAS IMPOSSIBLE TO DISCONNECT THE BAG FROM THE SYSTEM ONCE IT WAS FULL. IT SEEMED TO BE STUCK VERY TIGHTLY TOGETHER AT THE CONNECTION. THE NURSE TRIED TO USE 2 TOURNIQUETS TO REMOVE AND THEN A KELLY CLAMP. UNFORTUNATELY IT WOULD STILL NOT DISCONNECT AND THE TUBING WAS BENDING JUST BELOW THE HUB WHERE THE TUBING CONNECTED TO THE BAG. THE NURSE WAS CONCERNED THAT IT MIGHT CRACK OFF COMPLETELY. AFTER CHANGING THE SYSTEM, THEY WERE ABLE TO REMOVE THE BAG WITH 2 KELLY CLAMPS AND LOT OF FORCE AND HEARD A CRACK. THEY DID INSPECT THE CONNECTION, AND IT DIDN¿T SEEM TO BE CRACKED, BUT IT WAS DIFFICULT TO TELL GIVEN THE MARKS ON THE CONNECTION FROM THE KELLY CLAMPS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE- NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18835932 ↗
• MalfunctionJul 11, 2023Disconnection; Disconnection

  MEDTRONIC RECEIVED INFORMATION REGARDING A EXTERNAL DRAINAGE AND MONITORING DEVICE. IT WAS REPORTED THAT THE DEVICE DISCONNECTED. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17299857 ↗
• MalfunctionSep 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CLAMPS ON THE DEVICE WERE NOT CUTTING OFF FLOW OF CEREBROSPINAL FLUID.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8959613 ↗
• MalfunctionAug 26, 2019Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED REGARDING A PATIENT UNDERGOING CSF MANAGEMENT SURGERY. IT WAS REPORTED THAT THE EVD SMALL BELL WAS "DRAINED" TO THE WATER STORAGE BAG, AND THAT THE DRAINAGE TUBE WAS NOT COMPLETELY PACKAGED. THE ISSUE OCCURRED PRIOR TO USE, AND THE DEVICE WAS REPLACED AS A RESULT. THERE WERE NO RELATED PATIENT SYMPTOMS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT WHEN PLACING THE DRAINAGE TUBE, THE INTEGRITY OF THE PASSAGE HAD BEEN CONFIRMED, AND THERE WAS NO PULLING CONDITION. WHEN THE BLOOD WAS DRAINED, THE MAIN SYSTEM PISTON WAS LEAKING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8932696 ↗
• MalfunctionJun 12, 2019Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED REGARDING A PATIENT UNDERGOING CSF MANAGEMENT SURGERY. IT WAS REPORTED THAT THERE WAS CATHETER LEAKAGE. NO INTERVENTION WAS PERFORMED, AND NO BROKEN PIECES REMAINED INSIDE THE PATIENT. HOWEVER, THE PRODUCT WAS CONSIDERED DAMAGED. AS A RESULT THE PROCEDURE WAS COMPLETED WITH REPLACEMENT DEVICES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8692190 ↗
• MalfunctionMay 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORT THAT THE EXTERNAL VENTRICULAR DRAINAGE (EVD) CLAMPS BELOW THE CHAMBER WERE NOT FUNCTIONING AND CEREBROSPINAL FLUID WAS RUNNING INTO THE COLLECTION BAG.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8650589 ↗
• MalfunctionMay 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORT THAT THE EXTERNAL VENTRICULAR DRAINAGE (EVD) CLAMPS BELOW THE CHAMBER WERE NOT FUNCTIONING AND CEREBROSPINAL FLUID WAS RUNNING INTO THE COLLECTION BAG.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8650435 ↗
• MalfunctionMar 15, 2019Disconnection; Disconnection

  IT WAS REPORTED THE JOINT OF THE DRAINAGE TUBE WAS LOOSE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8425317 ↗
• MalfunctionFeb 28, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE DEVICE'S MAIN SYSTEM STOPCOCK WAS LEAKING. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8379034 ↗
• MalfunctionFeb 22, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE THERE WAS LEAKAGE FROM THE PRODUCT. NO PATIENT IMPACT INDICATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8362527 ↗
• MalfunctionFeb 19, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE STOPCOCK WAS LEAKING. THERE WERE NO RELATED PATIENT SYMPTOMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8350589 ↗
• MalfunctionDec 15, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT UNDERWENT A LUMBAR DRAIN. A PRESSURE CABLE WAS NOT HOOKED UP TO THE PATIENT UPON ADMISSION AND WHEN CONNECTED, THE DRAIN WAS NOT ABLE TO BE ZEROED OR SHOW A WAVEFORM, DESPITE CHANGING OUT THE PRESSURE CABLE AND ¿PDM BRICK.¿ WHEN ATTEMPTING TO ZERO, THE MONITOR DISPLAYED A MESSAGE SAYING ¿PRESSURE SENSED.¿ ANESTHESIA CALLED AND WAS AT BESIDE ALONG WITH THE SICU TEAM. FURTHER TROUBLESHOOTING WAS ATTEMPTED WITH NO SUCCESS. EVENTUALLY, USING A STERILE TECHNIQUE, THE TRANSDUCER ON THE LUMBER DRAIN WAS REPLACED WITH ANOTHER ONE FROM AN A-LINE SETUP AND WAS ABLE TO GET WAVEFORM TO TRANSDUCE PRESSURE. THIS PROCESS TOOK ABOUT TWO HOURS TO FIGURE OUT, DURING WHICH THE PATIENT WAS UNABLE TO HAVE CSF DRAINED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8167735 ↗
• MalfunctionNov 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DRAIN CLAMP COULDN'T BE CLAMPED INTRA OPERATIVELY. IT WAS NOTED THE PATIENT'S STATUS AT THE TIME OF THE RE PORT WAS ALIVE-NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8071861 ↗
• MalfunctionNov 13, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE MAIN SYSTEM STOPCOCK WAS LEAKING. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8064837 ↗
• MalfunctionOct 16, 2018Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THE EVD DRAINAGE LINE WAS DAMAGED AND LEAKING. IT WAS STATED THAT IT WAS TEMPORARILY COVERED WITH A CLOTH. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THE EVENT. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7969915 ↗
• MalfunctionOct 16, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE DRAINAGE VALVE ON THE PRODUCT WAS LEAKING. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THE EVENT. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7969765 ↗
• MalfunctionSep 11, 2018Break; Break

  IT WAS REPORTED THE PATIENT CONNECTION LINE WAS DAMAGED DURING THE PROCEDURE. THE CAUSE OF THE DAMAGE WAS UNKNOWN. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7863565 ↗
• MalfunctionAug 24, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WHEN THE DRAINAGE BAG WAS FULL AND CHANGED, THE DRAINAGE TUBE WAS FOUND TO BE LEAKING. THE DRAINAGE SYSTEM WAS REMOVED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7812360 ↗
• MalfunctionAug 2, 2018Disconnection; Loose or Intermittent Connection

  IT WAS REPORTED THE SYSTEM WAS PLACED ON (B)(6) 2018. THE TUBING WAS FOUND TO BE LOOSE AND DISCONNECTED NEAR THE INJECTION SITE BY ITSELF. THE SYSTEM WAS REPLACED ON (B)(6). THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7744649 ↗
• MalfunctionAug 2, 2018Disconnection; Loose or Intermittent Connection

  IT WAS REPORTED THE SYSTEM WAS PLACED ON (B)(6) 2018. THE TUBING WAS FOUND TO BE LOOSE AND DISCONNECTED NEAR THE INJECTION SITE BY ITSELF. THE SYSTEM WAS REPLACED ON (B)(6). THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

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

  MAUDE report 7744631 ↗
• MalfunctionJul 25, 2018Disconnection; Loose or Intermittent Connection

  IT WAS REPORTED THE PATIENT WAS CONNECTED TO THE DEVICE ON (B)(6) 2018, AND SINCE THEN, THE TUBING WAS FOUND TO BE LOOSE AND DISCONNECTED NEAR THE INJECTION SITE. IT WAS STATED THE DEVICE WAS REMOVED ON (B)(6) 2018 AND WOULD BE REPLACED WITH ANOTHER ONE. THE PATIENTS CONDITION REMAINED THE SAME AFTER THE INCIDENT. ACCORDING TO THE HEALTHCARE PROFESSIONALS, THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7719434 ↗
• MalfunctionDec 8, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THE DEVICE WAS LEAKING PRE-OPERATIVELY WHERE THE ¿TUBE CONNECTS TO THE BAG.¿ THE CAUSE OF THE ISSUE WAS NOT DETERMINED. THE DEVICE WAS REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7100605 ↗
• MalfunctionMay 26, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THERE WAS AN ISSUE CONNECTING A TRANSDUCER TO THE LUER LOCK PORT OF THE SYSTEM. ACCORDING TO THE REPORT, WHEN THE CUSTOMER ATTACHED THE TRANSDUCER TO THE DRAIN, IT CRACKED THE LUER LOCK CONNECTION. IT WAS STATED THIS CAUSED A LEAK IN THE SYSTEM AND THE SYSTEM KEPT LEAKING. REPORTEDLY, IT APPEARED THE TRANSDUCER SEEMED TO ONLY SCREW IN 2 THREADS INTO THE DRAIN WITH ONE THREAD LOOSE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6596212 ↗
• MalfunctionMar 9, 2017Break; Break

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT AFTER THE BAG WAS CHANGED OUT, THE INTEGRITY OF THE SYSTEM WAS DISRUPTED/CRACKED. ACCORDING TO THE REPORT, THERE WAS NO PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6393587 ↗
• MalfunctionJan 20, 2017Disconnection; Disconnection

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THERE WAS A ROUGH CONNECTION BETWEEN THE DRAINAGE BAG AND THE SYSTEM. ACCORDING TO THE REPORT, WHEN RETURNING TO THE ROOM, THE DRAIN WAS ON THE FLOOR. REPORTEDLY, THE DRAINAGE BAG FELL COMPLETELY OFF WHEN THE NURSE WENT TO EMPTY THE BAG.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6268698 ↗

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-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-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-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