Spheres 8801075 5/Tray 12pk recallZ-1596-2014 · Medtronic Navigation, Inc. · initiated Apr 24, 2014
Class II Terminated All recalls posted in May 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Navigation, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Domestic Urgent Medical Device Safety Notice letters were shipped on April 24 and 25, 2014. The letters indicated that a Medtronic representative will contact the hospital and arrange for a visit to collect affected products and arrange for no charge replacements or credit. Questions regarding this recall should be directed to Medtronic Navigation Technical Services at 1-800-595-9709.
Recall details
- Recall number
- Z-1596-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 24, 2014
- Posted by the FDA
- May 9, 2014
- Recalling firm
- Medtronic Navigation, Inc.
- Quantity
- 26,674 total
- Product code
- HAW
- FDA submissions
- K001284, K012937, K022074, K033621, K871247, K990214
- Distribution
- Nationwide Distribution
Product description
SPHERES 8801075 5/TRAY 12PK
Code information (models, lots, serial numbers)
Lot No.: 1207251 1301091 1301081 1211141 1301151 1302051 1303141 1303121 1303191 1304031 1304081 1303071 1305221 1305281 1306181 1306231 1307041 1307051 1307111 1307131 1307121
Other devices under the same FDA submission
27 devices cleared under K001284, K012937, K022074, K033621, K871247, K990214 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Fusion™ ENT Image Guidance System 9733560XOMMedtronic Navigation, Inc. · Neurological stereotaxic Instrument1,316 reports
- Fusion™ ENT Image Guidance System 9733560Medtronic Navigation, Inc. · Neurological stereotaxic Instrument458 reports
- Fusion™ ENT Image Guidance System 9733560XOMMedtronic Navigation, Inc. · Neurological stereotaxic Instrument188 reports
- Fusion™ ENT Image Guidance System 9733560XOMRMedtronic Navigation, Inc. · Neurological stereotaxic Instrument66 reports
- AXIEM™ 9733300Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 recall0 reports
- AXIEM™ 9731975Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 recall0 reports
- N/A 9733449Medtronic Navigation, Inc. · Neurological stereotaxic Instrument40 reports
- AxiEM™ 9733533XOMMedtronic Navigation, Inc. · Neurological stereotaxic Instrument24 reports
- N/A 9733450Medtronic Navigation, Inc. · Neurological stereotaxic Instrument16 reports
- NDI Passive Sphere 8801075Northern Digital Inc · Neurological Stereotaxic Instrument10 reports
- N/A 9733533XOMMedtronic Navigation, Inc. · Neurological stereotaxic Instrument8 reports
- N/A 9733533Medtronic Navigation, Inc. · Neurological stereotaxic Instrument7 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 68145).
- Z-1578-2014 · TerminatedBAG 9732315 MOUSE STERILE 15 PK
- Z-1579-2014 · TerminatedBIOPSY NEEDLE KIT, 9733068, PASSIVE
- Z-1580-2014 · TerminatedBIT 9733516 2.9mm DRILL STERILE
- Z-1581-2014 · TerminatedDISP 9730950 STRL SPHERE, 1 PK INSERT
- Z-1582-2014 · TerminatedDISP 9730951 STRL SPHERE, 5PK INSERT
- Z-1583-2014 · TerminatedDRAPE 9732722 TUBE STERILE O-ARM 20PK
- Z-1584-2014 · TerminatedENT PRGM 9734636 ADD FUSION NAV AxiEM
- Z-1585-2014 · TerminatedINST 9731132 KIT CR REF FRAME DRIVER 5PK
- Z-1586-2014 · TerminatedINSTRUMENT TRACKER 9733533XOM ENT 1PK
- Z-1587-2014 · TerminatedKIT, 9731427, THORACIC TACTILE PROBES
- Z-1588-2014 · TerminatedMOUSE 9732721 STERILE O-ARM 10PK
- Z-1589-2014 · TerminatedPACK 9731975 TUMOR RESECTION AXIEM CR
- Z-1590-2014 · TerminatedPAK 9733497 NAV NIM-SPINE PEDICLE ACC KT
- Z-1591-2014 · TerminatedPATIENT TRACKER 9733534XOM ENT 1PK
- Z-1592-2014 · TerminatedPIN, 9733235, 100MM, STERILE, PERC REF
- Z-1593-2014 · TerminatedPIN, 9733236, 150MM, STERILE, PERC REF
- Z-1594-2014 · TerminatedSHUNT KIT 9733605 NON-INVASIVE
- Z-1595-2014 · TerminatedSPHERES 8801071 1/TRAY 12PK
- Z-1597-2014 · TerminatedTRAJ GUIDE KIT, 9733065, BIOPSY, EXT
- Z-1598-2014 · TerminatedTRAJ GUIDE KIT, 9733066, BIOPSY, INT
- Z-1599-2014 · TerminatedTUMOR RES. PACK 9733553 AxiEM S.M.
- Z-1600-2014 · TerminatedTUMOR RESECTION KIT 9733607 NON-INVASIVE
- Z-1601-2014 · TerminatedTUMOR RESECTION KIT 9733608 SKULL MOUNT
- Z-1602-2014 · TerminatedUPGRD PRGM 9734638 ADD AxiEM NAVIGATION
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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