Medtronic Passive Biopsy Needle Kit, Part Number 9733068 - Passive Biopsy Needle Kit. The image guided Passive Biopsy Ne

FDA device recall Z-2324-2015 · posted 2015-08-03 · Terminated

Recall details

Recalling firm

Medtronic Navigation, Inc.

Reason for recall

The adhesive between the sphere assembly and the biopsy needle shaft may be compromised, causing the sphere assembly to move on the needle shaft. This may result in inaccurate navigation and improper placement of the needles biopsy window in the brain.

Action taken

Medtronic sent an Urgent Medical Device Recall letter dated July 17, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory for any of the affected lots and quarantine them if found. They will be asked to complete a confirmation form indicating they have completed this action and are to email or fax the form to Medtronic. Customers will be asked to contact Medtronic to obtain a return material authorization number and arrange for no-charge replacements of impacted products. Customers with questions were instructed to contact Medtronic Technical Services at 800-595-9709. For questions regarding this recall call 720-890-3302.

Root cause

Process change control

Status

Terminated

Product code

HAW

Quantity affected

1415 total

Distribution

Worldwide Distribution - US (nationwide) and Canada.

Date initiated

2015-07-17

Date posted

2015-08-03

Date terminated

2016-04-07

Location

Louisville, CO

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