Medtronic Passive Biopsy Needle Kit Recalled for Adhesive Defect
Medtronic is recalling 1,415 Passive Biopsy Needle Kits because compromised adhesive 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 medical device used for brain biopsies where a defect could lead to improper needle placement, posing a risk of significant injury.
Plain-English summary
Medtronic Navigation, Inc. is recalling 1,415 units of the Passive Biopsy Needle Kit, Part Number 9733068. These kits are accessory instruments used with the StealthStation System for stereotaxy biopsy of brain tissue. The affected units 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, which may result in inaccurate navigation and improper placement of the needle biopsy window in the brain.
The affected lot numbers are 066503515, 066504315, and 066506515. Healthcare providers and facilities should stop using these kits and contact Medtronic Navigation for further instructions on the recall.
The recalled product
- Product
- Medtronic Passive Biopsy Needle Kit, Part Number 9733068 - Passive Biopsy Needle 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.
- 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 (3)
- LOT No: 066503515
- 066504315
- 066506515
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.
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