Spheres 8801071 1/Tray 12pk recallZ-1595-2014 · 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-1595-2014
- 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 8801071 1/TRAY 12PK
Code information (models, lots, serial numbers)
Lot No.: 1203122 1205291 1206251 1306081 1309101
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-1596-2014 · TerminatedSPHERES 8801075 5/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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