Medtronic Recalls Delta Shunt Assembly Kits Due to Label Discrepancies
Medtronic Neurosurgery is recalling Delta Shunt Assembly Kits because label discrepancies were found. The recall covers 34 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 criteria for minor labeling errors or low-risk issues.
Plain-English summary
Medtronic Neurosurgery is recalling the Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0, Catalog No. 276201. The recall was initiated because the devices were found to have label discrepancies. These shunt assemblies are designed for use in shunting cerebrospinal fluid (CSF) from the lateral ventricle of the brain into the peritoneal cavity.
The recall involves 34 units with lot numbers D01859, D11969, D15985, D25462, D37523, and D42401. The products were distributed nationwide in the United States 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 the exact nature of the label discrepancies or provide specific instructions for consumers or healthcare providers on how to proceed. The agency classification for this recall is Class II.
The recalled product
- Product
- Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0, Catalog No. 276201. Delta Shunt Assemblies are designed for use in shunting CSF from the lateral ventricle of the brain into the peritoneal cavity.
- Manufacturer
- Medtronic Neurosurgery
- Hazard
- Affected units
- 34
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 (6)
- Lot Numbers: D01859
- D11969
- D15985
- D25462
- D37523
- D42401.
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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