Device recall: BAG 9732315 MOUSE STERILE 15 PK

Class II FDA enforcement event 68145. Recall start date: 24 Apr 2014. Status in the FDA record: Terminated. Termination date: 29 Dec 2014.

Reason for recall, in the words of FDA

Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Medtronic Navigation, Inc. started this device recall on 24 Apr 2014. The firm address in the FDA record is in Louisville, CO. FDA put the recall in Class II. FDA event 68145 has 25 product records. The first FDA enforcement report date is 26 Nov 2014. The record gives the status Terminated, with the termination date 29 Dec 2014.

FDA enforcement report The 25 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide Distribution

Recalling firm

Medtronic Navigation, Inc., Louisville, CO.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

25 product records in the event.

FDA event 68145: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1578-2014	BAG 9732315 MOUSE STERILE 15 PK	26,674 total	Class II	Terminated	26 Nov 2014
Z-1579-2014	BIOPSY NEEDLE KIT, 9733068, PASSIVE	26,674 total	Class II	Terminated	26 Nov 2014
Z-1580-2014	BIT 9733516 2.9mm DRILL STERILE	26,674 total	Class II	Terminated	26 Nov 2014
Z-1581-2014	DISP 9730950 STRL SPHERE, 1 PK INSERT	26,674 total	Class II	Terminated	26 Nov 2014
Z-1582-2014	DISP 9730951 STRL SPHERE, 5PK INSERT	26,674 total	Class II	Terminated	26 Nov 2014
Z-1583-2014	DRAPE 9732722 TUBE STERILE O-ARM 20PK	26,674 total	Class II	Terminated	26 Nov 2014
Z-1584-2014	ENT PRGM 9734636 ADD FUSION NAV AxiEM	26,674 total	Class II	Terminated	26 Nov 2014
Z-1585-2014	INST 9731132 KIT CR REF FRAME DRIVER 5PK	26,674 total	Class II	Terminated	26 Nov 2014
Z-1586-2014	INSTRUMENT TRACKER 9733533XOM ENT 1PK	26,674 total	Class II	Terminated	26 Nov 2014
Z-1587-2014	KIT, 9731427, THORACIC TACTILE PROBES	26,674 total	Class II	Terminated	26 Nov 2014
Z-1588-2014	MOUSE 9732721 STERILE O-ARM 10PK	26,674 total	Class II	Terminated	26 Nov 2014
Z-1589-2014	PACK 9731975 TUMOR RESECTION AXIEM CR	26,674 total	Class II	Terminated	26 Nov 2014
Z-1590-2014	PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT	26,674 total	Class II	Terminated	26 Nov 2014
Z-1591-2014	PATIENT TRACKER 9733534XOM ENT 1PK	26,674 total	Class II	Terminated	26 Nov 2014
Z-1592-2014	PIN, 9733235, 100MM, STERILE, PERC REF	26,674 total	Class II	Terminated	26 Nov 2014
Z-1593-2014	PIN, 9733236, 150MM, STERILE, PERC REF	26,674 total	Class II	Terminated	26 Nov 2014
Z-1594-2014	SHUNT KIT 9733605 NON-INVASIVE	26,674 total	Class II	Terminated	26 Nov 2014
Z-1595-2014	SPHERES 8801071 1/TRAY 12PK	26,674 total	Class II	Terminated	26 Nov 2014
Z-1596-2014	SPHERES 8801075 5/TRAY 12PK	26,674 total	Class II	Terminated	26 Nov 2014
Z-1597-2014	TRAJ GUIDE KIT, 9733065, BIOPSY, EXT	26,674 total	Class II	Terminated	26 Nov 2014
Z-1598-2014	TRAJ GUIDE KIT, 9733066, BIOPSY, INT	26,674 total	Class II	Terminated	26 Nov 2014
Z-1599-2014	TUMOR RES. PACK 9733553 AxiEM S.M.	26,674 total	Class II	Terminated	26 Nov 2014
Z-1600-2014	TUMOR RESECTION KIT 9733607 NON-INVASIVE	26,674 total	Class II	Terminated	26 Nov 2014
Z-1601-2014	TUMOR RESECTION KIT 9733608 SKULL MOUNT	26,674 total	Class II	Terminated	26 Nov 2014
Z-1602-2014	UPGRD PRGM 9734638 ADD AxiEM NAVIGATION	26,674 total	Class II	Terminated	26 Nov 2014

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2014: 1,176
Share of these events in Class II: 91%
Product records in this event: 25Median of the firm: 1
Events of the firm on the register: 44

Other events of the firm

Other FDA enforcement events of Medtronic Navigation, Inc.
Initiated	Product (first record)	Type	Class	Records
4 Dec 2024	Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Ster	Device	Class II	1
22 Aug 2024	StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine s	Device	Class II	1
26 Mar 2024	Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for	Device	Class I	1
28 Nov 2023	Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS	Device	Class II	2
27 Sep 2023	StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Crania	Device	Class I	1
11 Apr 2023	StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems	Device	Class I	1
11 Apr 2023	StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems	Device	Class I	1
15 Dec 2022	AxiEM" Non-Invasive Patient Tracker	Device	Class II	1
8 Dec 2022	RadiaLux Lighted Retractor (Pink), REF: 50-101-1	Device	Class II	1
14 Oct 2022	Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulat	Device	Class II	1

Medtronic Navigation, Inc.: all 44 events

Official channels

FDA enforcement report Z-1578-2014The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 68145. https://recallregister.com/fda/ii/68145/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide Distribution
What quantity of product is in FDA event 68145?: The event has 25 product records. The first record gives this quantity: 26,674 total
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2014 have the same class?: 91% of the 1,176 device events that started in 2014 are in Class II.