The Recall Desk
SevereFDA (Devices)·Z-2356-2018·Announced 2018-07-11

FHC Depth Stop Adapter Recalled for Potential Lead and Stylet Damage

FHC, Inc. is recalling the microTargeting Drive System Depth Stop Adapter because over-tightening the screw can damage implanted leads, requiring replacement.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a medical device defect that has resulted in the need for surgical removal and replacement of implanted leads, which constitutes a significant injury risk and aligns with the 'Severe' criteria for significant injury reports or high-risk device defects.

Plain-English summary

FHC, Inc. is recalling the microTargeting Drive System, Product Number 9033G0601, distributed by Medtronic. The recall involves 2,952 units of the FHC Depth Stop Adapter. These devices were distributed to numerous US states and foreign countries, including Argentina, Australia, Canada, and Germany.

The recall is due to a risk that the Depth Stop Adapter may cause damage to the lead and stylet if the depth stop screw is over-tightened onto the lead. This damage can result in low impedances or a short circuit between electrode pairs in the lead. The source text states that this issue has resulted in the need to remove and replace the implanted lead during intraoperative or follow-up procedures.

Healthcare providers and patients who have used this device should contact FHC, Inc. or Medtronic for instructions on how to proceed. The source text does not specify a specific action for consumers beyond the general recall notification, but it notes that the damage has necessitated surgical intervention in some cases.

The recalled product

Product
microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601
Manufacturer
FHC, Inc.
Category
Medical Device — Neurostimulation / Lead Accessories
Hazard
Affected units
2,952

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)

  • REF 9033G0601

Distribution

Distributed in 46 states:

Part of a larger recall action

This product is one of 15 recalled by FHC, Inc. 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 15 products in this recall →

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Same hazard · device damage

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