The Recall Desk
HighFDA (Devices)·Z-1121-2017·Announced 2017-02-08

Medtronic Strata II Valves Recalled for Pressure Discrepancies

Medtronic is recalling Strata II and Strata NSC valves used for hydrocephalus management due to reported discrepancies between the set pressure level and x-ray readings.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device where a functional discrepancy (pressure level mismatch) poses a risk of harm, but the source text does not explicitly report injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medtronic Neurosurgery is recalling Strata II and Strata NSC valves, which are shunt components used in the management of hydrocephalus. These valves are designed to allow for the continuous flow of cerebrospinal fluid from the ventricles of the brain to the peritoneal cavity or right atrium of the heart. The recall includes all catalog numbers for the Strata Valve Magnet Reverse Polarity, excluding the StrataMR model.

The recall was initiated after the manufacturer received five product experience reports between February 15, 2015, and August 23, 2016. These reports indicated discrepancies between the pressure/performance level at which the valve was set and the readings determined via x-ray images. The affected units were distributed worldwide, including the United States, Puerto Rico, and numerous international locations.

Patients with these implanted devices should contact their healthcare provider to discuss the recall and determine if any further evaluation or action is necessary. The recall covers 315,997 units across all lot numbers.

The recalled product

Product
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 II/Strata NSC valve is a shunt component designed to allow for continuous flow of cerebrospinal f
Manufacturer
Medtronic Neurosurgery
Category
Medical Device — Neurosurgical Shunt
Hazard
Affected units
315,997

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All Lot Numbers

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same manufacturer · Medtronic Neurosurgery

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