Medtronic StrataMR Valves Recalled for Incorrect Rotor Orientation

Plain-English summary

Medtronic Neurosurgery is recalling 2,622 units of StrataMR adjustable valves and shunts. The recall is due to a manufacturing issue where the valve rotor may be misaligned or off-center, resulting in incorrect orientation. This defect causes higher valve opening pressures, which leads to underdrainage of cerebrospinal fluid (CSF).

The affected products were distributed throughout the United States and to 21 other countries, including Australia, Canada, Germany, and the UK. The specific catalog numbers and lot codes are listed in the structured product information. The StrataMR valves are designed to manage hydrocephalus by providing continuous CSF flow from the brain to the heart or peritoneal cavity.

If the valve is set in the incorrect orientation, patients may experience adverse health consequences such as ventriculomegaly, headaches, nausea, vomiting, and lethargy. The source text states that if left untreated, underdrainage has the potential to lead to coma and death. Patients with these devices should contact their healthcare provider for evaluation and potential corrective action.

The recalled product

Product

The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design enables the physician to non-invasive adjust valve pressu

Manufacturer

Medtronic Neurosurgery

Category

Medical Device — Neurosurgery / Shunts

Hazard

• underdrainage
• coma
• death

Is your product affected?

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

Distribution

Distribution scope not specified by the agency.

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