Strata® 46866 (UDI 00763000027490)Recalls & reported problems

Medtronic Ps Medical, Inc. · ASSY 46866 FP-STRATA 2 SHUNT REG · Class 2 · Implant

All models of Strata (53)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000027490), received between Oct 10, 2024 and Jul 30, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Insufficient Device Problem Information1
Mechanical Jam1
Mechanics Altered1

Patient problems

No Clinical Signs, Symptoms or Conditions2
Ambulation or Postural Difficulties1
Cognitive Changes1
Headache1
Incontinence1
Pain1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

InjuryJul 30, 2026Mechanics Altered; Insufficient Device Problem Information
Medtronic received information regarding an adjustable shunt. It was reported that the shunt was implanted on January 30, 2024. The shunt failed to function for hydrocephalus spinal fluid drainage and was successfully replaced on (b)(6), 2025.
Patient problems: Ambulation or Postural Difficulties; Cognitive Changes; Headache; Incontinence; No Clinical Signs, Symptoms or Conditions; Pain
MAUDE report 50083054 ↗
InjuryOct 10, 2024Mechanical Jam; Mechanical Jam
MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT THE VALVE WAS IMPLANTED A FEW YEARS AGO, AND THEY WANTED TO REPROGRAM IT. IT WAS STATED THAT REPROGRAMMING THE VALVE DID NOT WORK INSIDE THE PATIENT. THE VALVE WAS REPLACED. IT WAS TESTED OUTSIDE THE PATIENT, AND IT WAS ABLE TO BE REPROGRAMMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20416398 ↗

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

Device details

UDI-DI	`00763000027490`
Brand	Strata®
Model	46866
Company	Medtronic Ps Medical, Inc.
Product code	JXG · Shunt, central nervous system and components
Class	Class 2
FDA submission	K060681
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Oct 10, 2022

Device type (GMDN): Ventriculoperitoneal shunt

An implantable device intended to divert excessive cerebrospinal fluid (CSF) from the brain ventricles to the peritoneal cavity, where it can be absorbed into the body, as a treatment for increased intracranial pressure (e.g., caused by hydrocephalus). It typically consists of three main connected parts: 1) an intracerebral ventricular catheter through which CSF flows; 2) a mechanical shunt valve that typically opens at a pre-set pressure; and 3) a peritoneal catheter that channels the CSF to the peritoneal cavity. It is made of plastic and silicone materials; disposable devices associated with implantation may be included.

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All Shunt, central nervous system and components devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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