Medtronic SharkCore Fine Needle Biopsy System Recalled for Handle Breakage
Medtronic is recalling SharkCore Fine Needle Biopsy Systems because the handle may break during use, posing a risk of injury to patients or providers.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a structural defect (handle breakage) that poses a risk of harm to patients or providers, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic is recalling the SharkCore Fine Needle Biopsy System (22 GA), Material/Part # DSC-22-01. The recall is being conducted because the handle of the device may break during use.
The affected units were distributed in the United States to 38 states and the District of Columbia, as well as to Denmark and Germany. The specific lot numbers involved in this recall are B000000164, B000000170, B000000173, and B000000178.
Healthcare providers and consumers should stop using the affected SharkCore Fine Needle Biopsy Systems immediately. Users should contact Medtronic for instructions on how to return the devices or obtain a replacement.
The recalled product
- Product
- SharkCore Fine Needle Biopsy System (22 GA); Material/Part #s: DSC-22-01
- Manufacturer
- Medtronic
- Hazard
- Affected units
- 1,096
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 (4)
- Lot Number: B000000164
- B000000170
- B000000173
- B000000178
Distribution
Part of a larger recall action
This product is one of 5 recalled by Medtronic 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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