Medtronic Recalls Strata II Shunt Kits Due to Label Discrepancies
Medtronic Neurosurgery is recalling Strata II Shunt Assembly Kits and other CSF shunts because of label discrepancies. The recall affects 5 units distributed worldwide.
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: The recall is classified as FDA Class II and involves label discrepancies, which aligns with the rubric for minor labeling errors or low-risk issues without reported injuries.
Plain-English summary
Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit. The recall was initiated because these devices were found to have label discrepancies.
The specific product identified in the structured data is the Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848. These shunt assemblies are designed to provide continued cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The recall involves 5 units with Lot Numbers D22311 and D37565.
The affected units were distributed nationwide in the USA and internationally to Austria, Belgium, Bosnia, Herzegovina, Canada, Croatia, Germany, Japan, Poland, Portugal, Taiwan, the United Arab Emirates, and the United Kingdom. The source text does not specify further actions for consumers or healthcare providers beyond the recall notice.
The recalled product
- Product
- Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848. Strata II Shunt Assemblies are designed to provide continued cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart of the peritoneal cavity.
- Manufacturer
- Medtronic Neurosurgery
- Hazard
- Affected units
- 5
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 Numbers: D22311
- D37565.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Medtronic Neurosurgery under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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