Z-2324-2015Class II

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

Name: Z-2324-2015 Medtronic Passive Biopsy Needle Kit, Part Number 9733068 - Passive Biopsy Needle Kit. The image guided...
Creator: Medtronic Navigation, Inc.
Published: 2015-07-17
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2015-07-17 / Terminated

FDA source

Medtronic Navigation, Inc. began a recall of Medtronic Passive Biopsy Needle Kit, Part Number 9733068 - Passive Biopsy Needle Kit. The image guided Passive Biopsy Needle is an accessory instrument with... on 2015-07-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2324-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-17
Posted: 2015-08-03
Terminated: 2016-04-07
Recalling firm: Medtronic Navigation, Inc
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.
Product code: HAW Neurological Stereotaxic Instrument
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.
FDA 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 products. Customers with questions were instructed to contact Medtronic Technical Services at 800-595-9709. For questions regarding this recall call 720-890-3302.
Quantity in commerce: 1415 total
Distribution: Worldwide Distribution - US (nationwide) and Canada.
Product codes and lots: LOT No: 066503515, 066504315, 066506515

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2324-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2324-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-12	2015-08-03
Z-2325-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-12	2015-08-03

Product code HAW

K971247Class IISnt Disposable Biopsy NeedleSurgical Navigation Technologies, Inc. / cleared 1997-06-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)