Z-1794-2015Class II

Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540...

Name: Z-1794-2015 Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540...
Creator: Medtronic Navigation, Inc.
Published: 2015-05-05
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2015-05-05 / Terminated / root cause: manufacturing process

FDA source

Medtronic Navigation, Inc. began a recall of Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540, 9732622, 9733174, 9733935. As part of kits, the product... on 2015-05-05. FDA classified it as Class II and gives the reason as "Passive Planar Blunt Probe (Lot# 150223) was manufactured with a sharp tip rather than a blunt tip". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1794-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-05
Posted: 2015-06-12
Terminated: 2015-07-02
Recalling firm: Medtronic Navigation, Inc
Product: Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540, 9732622, 9733174, 9733935. As part of kits, the product is either packaged with other instruments or into a holding tray. The Passive Planar Blunt Probe is an optically tracked, reusable instrument used in navigated surgery and is included with Medtronic cranial instrument kits. It is designed for use in patient registration and palpating brain tissue during surgical procedures.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Passive Planar Blunt Probe (Lot# 150223) was manufactured with a sharp tip rather than a blunt tip.
Root cause tag: manufacturing process
FDA root cause: Mixed-up of materials/components
Action: Medtronic sent an Medical Device Safety Alert letter dated May 5, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action to be taken by the user: "Examine your inventory and if any of the affected products are found, please quarantine them for return to Medtronic. "A Medtronic representative will follow-up to arrange for removal and replacement. If you have any questions regarding this action, please contact Medtronic Navigation Technical Services at 1-800-595-9709.
Quantity in commerce: 18
Distribution: US Distribution to the states of : CA, MO, LA and PA., and Internationally to Ireland.
Product codes and lots: lot number 150223

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1794-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1794-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-24	2015-06-12

Product code HAW

K972398Class IIStealthstation Passive Instrument OptionSurgical Navigation Technologies, Inc. / cleared 1997-09-16

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)