Medtronic StrataMR Valves Recalled for Incorrect Rotor Orientation
Medtronic is recalling StrataMR valves and shunts because incorrect rotor orientation can cause underdrainage of cerebrospinal fluid, potentially leading to serious health consequences.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the defect has the potential to lead to coma and death, which aligns with the rubric criteria for Severe (4) involving significant injury or risk of serious harm.
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…
- Manufacturer
- Medtronic Neurosurgery
- Hazard
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 (20)
- Worldwide Catalog Number 42955
- VALVE 42955 FP-STRATAMR SMALL E03581
- E04352
- E05120
- E05121
- E06139
- E06476
- E09475
- E11656
- E12556
- E12753
- E13482
- E13483
- E13484
- E13641
- E14518
- E14519
- E18555
- E18556
- E18557
Distribution
Distribution scope not specified by the agency.
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