Duet® 46917 (UDI 00613994445407)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994445407), received between Aug 8, 2017 and Jan 18, 2022 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

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

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.

Recalls naming this device

1. Jan 22, 2024Open, Classified

   Potential for catheter disconnection from the patient line stopcock connectors.

   Z-1166-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 18, 2022Disconnection; Disconnection

  MEDTRONIC RECEIVED INFORMATION REGARDING A CATHETER. IT WAS REPORTED THAT THE EXTERNAL LUMBAR DRAINAGE KIT WAS IMPLANTED ON (B)(6) 2022, AND TODAY, (B)(6) 2022, DETACHMENT OF THE CONNECTION TO THE CATHETER WAS OBSERVED AFTER A SUBTLE MOVEMENT OF THE CATHETER. THIS WAS REPORTED OUTSIDE OF A PROCEDURE, WHILE THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU). THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13282463 ↗
• InjuryOct 27, 2020Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT WAS ADMITTED FOR RIGHT OTORRHEA FOR REPAIR, INSERTION OF THE LUMBAR DRAIN, AND EXPLORATION OF SPHENOID SINUS UNDER A NEUROSURGEON AND ENT SURGEON. ON (B)(6) 2020, SEPTOPLASTY AND ENDOSCOPY SPHENOIDOTOMY WERE PERFORMED AND ENDED UNEVENTFULLY. THE LUMBAR DRAIN WAS INSERTED FOR CONTINUOUS MONITORING OF THE CEREBROSPINAL FLUID LEAK. ON (B)(6) 2020, THE NEUROSURGEON REMOVED THE LUMBAR DRAIN AT THE PATIENT'S BED SIDE WITH ASSISTANCE FROM A NURSE. DURING REMOVAL, THE LUMBAR DRAIN FRACTURED. CT OF THE LUMBAR SPINE SHOWED THE FRACTURED END OF THE RETAINED DRAIN WAS IN THE SUBCUTANEOUS TISSUE EXTENDING INTO THE INTRA-DURAL SPACE. THERE WAS NO INTRA-THECAL HEMORRHAGE. ON SEPTEMBER 4, 2020, THE PATIENT UNDERWENT THE REMOVAL OF THE FRACTURED LUMBAR DRAIN. THE PROCEDURE ENDED UNEVENTFULLY. THE PATIENT WAS DISCHARGED AND WAS WELL ON (B)(6) 2020.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10743107 ↗
• InjuryDec 20, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE SURGEON WAS REMOVING THE LUMBAR DRAIN CATHETER FROM THE PATIENT 3 DAYS AFTER IMPLANTATION. THERE WAS NO ISSUE DURING THE INSERTION OF THE IMPLANT. PRIOR TO REMOVAL, THE DRAINING OF THE CEREBROSPINAL FLUID WAS OPTIMAL AND EFFICIENT. NO UNUSUAL SYMPTOMS OR EVENTS OCCURRED. HOWEVER, UPON REMOVAL, THE SURGEON ENCOUNTERED A SLIGHT/LIGHT RESISTANCE WHILE PULLING OUT THE CATHETER. THE SURGEON FOUND THE CATHETER WAS BROKEN. APPROXIMATELY 8.7 CM WAS FOUND TO BE STUCK IN THE PATIENT'S LUMBAR SPINE. THE REMNANT LUMBAR DRAIN WAS VISUALIZED IN ONE CONTINUOUS SEGMENT 8.7 CM FROM ITS TIP ABUTTING THE RIGHT SUPERIOR CORNER OF THE L3 VERTEBRA (NEXT TO THE RIGHT L3 PEDICLE) THROUGH THE L4/5 INTERSPINOUS LIGAMENT VIA A LEFT PARACENTRAL APPROACH, TO ITS PROXIMAL BREAKAGE POINT ABOUT 3 CM DEEP FROM THE SKIN. IT WAS NOTED THAT A SUBSEQUENT X-RAY WAS TAKEN, AND AN EXPLORATORY SURGERY WAS PERFORMED TO LOCATE THE BROKEN CATHETER FROM THE PATIENT. HOWEVER, THEY WERE UNABLE TO LOCATE AND REMOVE THE REMAINING OF THE IMPLANT. THE PATIENT WAS HEALTHY AND RECOVERING WELL DESPITE THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9507540 ↗
• InjuryApr 23, 2018Fracture; Device Or Device Fragments Location Unknown; Appropriate Device Problem Term/Code Not Available; Fracture; Device Or Device Fragments Location Unknown; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT HAD A LUMBAR DRAIN DONE ON (B)(6) 2018. THE FOLLOWING DAY, THE SURGEON WAS TO REMOVE THE CATHETER AS THERE WAS NO DRAINAGE AND THE PATIENT HAD SWELLING ON THE BRAIN. RESISTANCE WAS FELT DURING THE REMOVAL AND AS THE SURGEON WAS PULLING, THE CATHETER BROKE INTO TWO PIECES. A PORTION WAS LEFT IN THE SUBARACHNOID SPACE. AN OPERATION TO REMOVE THE PIECE WAS DONE, BUT WAS UNSUCCESSFUL. THE SURGEON PERFORMED A LAMINECTOMY AT L4-L5, BUT THE BROKEN PIECE WAS FLOATING WITHIN THE SPACE. A SECOND DRAIN WAS INSERTED, AND THE PATIENT¿S STATUS WAS LISTED AS ALIVE ¿ NO INJURY.

  Patient problems: Device Embedded In Tissue or Plaque; Swelling

  MAUDE report 7451891 ↗
• MalfunctionAug 8, 2017Break; Break

  IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE CATHETER HAD A SLIT/TEAR. ACCORDING TO THE REPORT, THERE WAS NO INJURY TO THE PATIENT, AND THEY HAD BEEN DISCHARGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6775221 ↗

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-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-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