Agency classClass IIOur severity:Severe FDA (Devices)·Z-2325-2015·Announced 2015-08-12

Medtronic Passive Biopsy Needle Kit Recalled for Adhesive Defect

Medtronic is recalling 1,415 Passive Biopsy Needle Kits because adhesive failure may cause the sphere assembly to move, leading to inaccurate navigation during brain biopsies.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 defect in a medical device used for brain biopsies that could lead to improper needle placement, meeting the criteria for a Severe rating due to the potential for significant injury.

Plain-English summary

Medtronic Navigation, Inc. is recalling 1,415 units of the Passive Biopsy Needle Kit, Part Number 9731754. The product is an accessory instrument used with the StealthStation System for stereotaxy biopsy of brain tissue. The recall covers units with lot numbers 0007525461 and 0007599312, which were distributed nationwide in the United States and in Canada.

The recall was initiated because the adhesive between the sphere assembly and the biopsy needle shaft may be compromised. This defect can cause the sphere assembly to move on the needle shaft, potentially resulting in inaccurate navigation and improper placement of the needle biopsy window in the brain.

The agency has classified this as a Class II recall. Healthcare providers and facilities that have used or possess these specific kits should stop using them and contact Medtronic Navigation, Inc. for instructions on return or replacement.

The recalled product

Product: Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU) Kit. The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.
Manufacturer: Medtronic Navigation, Inc.
Category: Medical Device — Surgical Instrument
Hazard: inaccurate-navigation
improper-placement
Affected units: 1,415

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 No: 0007525461. 0007599312

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Medtronic Navigation, 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 2 products in this recall →

Same manufacturer · Medtronic Navigation, Inc.

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