N/A 46441Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20643169471515), received between Jun 12, 2018 and Jun 12, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2018Device Operates Differently Than Expected; Insufficient Device Problem Information; Device Operates Differently Than Expected; Insufficient Device Problem Information

  IT WAS REPORTED THE HEALTHCARE PROFESSIONAL (HCP) EXPERIENCED DIFFICULTIES DURING THE PLACEMENT OF THE LUMBAR CATHETER. IT WAS STATED THERE WAS A POSSIBLE PROBLEM WITH THE TUOHY NEEDLE DUE TO MISALIGNMENT BETWEEN THE CATHETER AND NEEDLE. THERE REPORTEDLY WAS A POSSIBILITY OF THE CATHETER BREAKING, BUT THE HCP WAS CAREFUL DURING THE MANIPULATION AND COMPLETELY EXPLANTED THE PRODUCT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7592871 ↗

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-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-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
• 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