Recall Z-2325-2015 ยท HAW Neurological Stereotaxic Instrument
Medtronic Navigation, Inc.
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.
| Date | Aug 3, 2015 (initiated Jul 17, 2015) |
| Status | Terminated |
| Reason | 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 | Process change control |
| Action | 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 prod |
| Quantity | 1415 total |
| Distribution | Worldwide Distribution - US (nationwide) and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971247 | SNT DISPOSABLE BIOPSY NEEDLE Surgical Navigation Technologies, Inc., Jun 16, 1997 |