CLASS II Device recall · Reported 22 Mar 2017 · FDA Enforcement Report

SharkCore Fine Needle Biopsy System recalled by Medtronic

Medtronic is recalling SharkCore Fine Needle Biopsy System, distributed in 40 states. The recall was initiated on 8 Feb 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot number: B000000174

Quantity recalled1,096 Units (total for all products)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1474-2017
FDA event ID: 76497
Recalling firm: Medtronic, North Haven, CT
Classification: Class II
Status: Terminated
Recall initiated: 8 Feb 2017
FDA classified: 15 Mar 2017
Reported: 22 Mar 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Syringes & Needles

Timeline

8 Feb 2017	Recall initiated by company
15 Mar 2017	Classified by FDA	+35 days
22 Mar 2017	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Handle may break during use.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

SharkCore Fine Needle Biopsy System (25GA); Material/Part#: DSC-25-01

Where it was distributed

US Distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI; and countries of DK and DE

Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Illinois Indiana Kansas Louisiana Massachusetts Maryland Michigan Minnesota

Questions about this recall

Is SharkCore Fine Needle Biopsy System recalled?

Yes. Medtronic recalled SharkCore Fine Needle Biopsy System on 8 Feb 2017. The recall is Class II and its status is Terminated. Recall number Z-1474-2017.

Why was it recalled?

Handle may break during use.

Which lots are affected?

Lot number: B000000174

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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