Medtronic ventricular catheter system recalled due to incorrect labeling expiration date
Medtronic is recalling 44 units of the Duet External Drainage and Monitoring system because the product labels contain an incorrect expiration date. The affected lot (226632942) was distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for a labeling error—an incorrect expiration date on the product label. No illnesses or injuries have been reported. Per the severity rubric, labeling errors without reported adverse events fall under Moderate severity.
Plain-English summary
The Medtronic REF 46915 Duet External Drainage and Monitoring system with Interlink Injection sites and Ventricular Catheter is being recalled due to product labeling that contains an incorrect expiration date.
Forty-four units were distributed nationwide, primarily in New Jersey, Florida, California, and Illinois. The affected lot number is 226632942 (UDI-DI: 00763000624781).
Healthcare providers and patients who have this device should contact Medtronic Neurosurgery to verify the correct expiration date for their specific unit and consult their healthcare provider regarding proper device use.
The recalled product
- Product
- Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only
- Manufacturer
- Medtronic Neurosurgery
- Hazard
- Affected units
- 44
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 (2)
- Lot # 226632942
- UDI-DI: 00763000624781
Distribution
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