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STar Drive MA recallZ-2357-2018 · FHC, Inc. · initiated May 10, 2018

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from FHC, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure.

FDA root cause category: Device Design

What the company is doing

Urgent Medical Device Recall notification letters were sent to customers on 5/10/18. The letters included the following instructions: FHC, Inc. Field Representatives will review your inventory and replace effected Depth Stop Adapters you have on hand with an improved design. In the interim, we advise that you do not over-tighten the Depth Stop Adapter screw. If low impedances or a short circuit is found, physicians should replace the lead prior to use and report the issue to FHC, Inc. or your local field rep.

Recall details

Recall number
Z-2357-2018
Status
Terminated
Initiated by the company
May 10, 2018
Recalling firm
FHC, Inc.
Quantity
2952 total
Product code
HAW
FDA submissions
K092562
Distribution
The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The devices were distributed to the following foreign countries: Argentina, Australia, Canada, Columbia, Denmark, Ecuador, France, Germany, Great Britain, Italy, Japan, Norway, Romania, South Africa, Switzerland, Saudi Arabia, Taiwan.

Product description

microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001

Code information (models, lots, serial numbers)

UDI: 00873263001486, 00873263006351

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

7 devices cleared under K092562 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 80148).

Sources and updates

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