The Recall Desk
HighFDA (Devices)·Z-1474-2017·Announced 2017-03-22

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. The recall covers 1,096 units distributed in the US and two countries.

What this means for you

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 is classified as FDA Class II and involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Medtronic is recalling the SharkCore Fine Needle Biopsy System (25GA), Material/Part#: DSC-25-01. The recall is being conducted because the handle of the device may break during use.

A total of 1,096 units are affected by this recall. The products were distributed in the United States to 38 states and the District of Columbia, as well as to Denmark and Germany. The specific lot number for the recalled product is B000000174.

This recall is classified as Class II by the U.S. Food and Drug Administration. Consumers and healthcare providers should stop using the affected devices and contact Medtronic for further instructions.

The recalled product

Product
SharkCore Fine Needle Biopsy System (25GA); Material/Part#: DSC-25-01
Manufacturer
Medtronic
Category
Medical Device — Biopsy System
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 (1)

  • Lot number: B000000174

Distribution

Distributed in 40 states:

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.

See all 5 products in this recall →

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