—#138972

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.

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K971247
Affected lot / code info: LOT No: 0007525461. 0007599312

Why it was recalled

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.

Root cause (FDA determination)

Process change control

Action the firm took

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.

Recalling firm

Firm: Medtronic Navigation, Inc.
Address: 826 Coal Creek Cir, Louisville, Colorado 80027-9710

Distribution

Distribution pattern: Worldwide Distribution - US (nationwide) and Canada.

Timeline

Recall initiated: 2015-07-17
Posted by FDA: 2015-08-03
Terminated: 2016-04-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #138972. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.