Strata™ 46856Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169975958), received between Apr 21, 2022 and Apr 29, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K060681); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2022Break; Fracture; Infusion or Flow Problem; Break; Fracture; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH THE SHUNT, BUT LATELY WAS OBSERVED THAT THERE WAS NO PROPER CSF DRAINAGE. THE HEALTH CARE PROFESSIONAL EXAMINED AND OBSERVED THAT THE SHUNT WAS BROKEN AND MALFUNCTIONED. THE PROCEDURE WAS COMPLETED AND NOW NEEDS REVISION AS THE PRODUCT IS NOT FUNCTIONAL. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE HEALTH CARE PROFESSIONAL DID NOT KNOW THE SHUNT WAS NOT FUNCTIONING CORRECTLY WHEN IT WAS IMPLANTED INTO THE PATIENT. THE PATIENT WAS IMPLANTED WITH THE DEVICE FOR 2 YEARS AND 4 MONTHS BEFORE IT STARTED TO MALFUNCTION. THE PATIENT EXPERIENCED THE FOLLOWING SYMPTOMS: HEADACHE, SEIZURES , CSF WAS GETTING COLLECTED IN THE BRAIN PARENCHYMA. AFTER THE PROCEDURE THE PATIENT WAS DOING WELL UNTIL THIS (B)(6) WHICH WAS HIS LAST FOLLOW UP. THE REVISION SURGERY WAS ON (B)(6) 2022.

  Patient problems: Cerebrospinal Fluid Leakage; Convulsion/Seizure; Headache

  MAUDE report 14253156 ↗
• MalfunctionApr 21, 2022Break; Fracture; Insufficient Device Problem Information; Break; Fracture; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION LEFT VP SHUNT USING MEDTRONIC PROGRAMMABLE SHUNT ON (B)(6) 2019. THE PATIENT UNDERWENT SHUNT REMOVAL ON (B)(6) 2022. INTRAOPERATIVELY, IT WAS FOUND THAT THE SHUNT HAD MALFUNCTIONED AND BROKEN WITHIN A PERIOD OF 2 YEARS. IT WAS ALSO REPORTED THAT IT WAS UNKNOWN IF THE PRODUCT WAS DAMAGED, WHICH IS CONTRADICTORY. DELAY INFORMATION WAS UNKNOWN. IT WAS NOTED THAT IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14167590 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060681. One submission often covers many models, so check the product and lot details in each record.

• Z-1116-2021 · Jan 11, 2021 · Open, Classified
  Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves and Shunts for the following CFNs: 27739 - SHUNT 27739 STRATA NSC SNAP SML 120CM, 27740 - SHU
• Z-1121-2017 · Jan 17, 2017 · Terminated
  Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Catalog Numbers. Strata-type valves are used in the management of hydrocephalus. The Strata