Cochlear™ Magnet (2M Sand) Z586147Recalls & reported problems
Cochlear Limited · 2M Sand · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09321502036917), received between Oct 24, 2017 and Oct 24, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Missing Value Reason” (1 report).
3 other recalls cover devices cleared under the same FDA submission (P970051); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Missing Value Reason1
Patient problems
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 24, 2017Missing Value Reason; Missing Value Reason
PER THE CLINIC, THE PATIENT EXPERIENCED A BREAKDOWN OF THE SKIN AT THE PROCESSOR MAGNET SITE, DUE TO THE MAGNET STRENGTH OF THE COIL. SUBSEQUENTLY, THE MAGNET STRENGTH WAS REDUCED AND THE PATIENT RECEIVED TREATMENT OF ORAL AND TOPICAL ANTIBIOTICS (DATE NOT REPORTED). THE PATIENT CONTINUES TO BE CLINICALLY MANAGED BY THEIR HEALTHCARE PROVIDER.
Patient problems: Patient Problem/Medical Problem
MAUDE report 6975082 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P970051. One submission often covers many models, so check the product and lot details in each record.
- Z-2155-2015 · Jun 5, 2015 · TerminatedCochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to check the size of the periosteal pocket, t
- Z-0003-2012 · Sep 16, 2011 · TerminatedCochlear Nucleus CI512 Cochlear Implant, REF Z209051, New with Nucleus 5, Sterile EO, Made in Australia, Cochlear Ltd 14 Mars Road, Lane Cove 2066, Australia. The cochlear implant
- Z-0119-2010 · Sep 30, 2009 · TerminatedNucleus Non-Magnetic Plug for removable magnet implants, REF Z50100, STERILE EO, Cochlear Limited.
Other IMPLANT, COCHLEAR devices
- HiRes™ Ultra CI HiFocus™ MS Electrode CI-1600-04Advanced Bionics AG · Implant, Cochlear2,918 reports
- Cochlear® Nucleus® CI512 cochlear ImplantCochlear Limited · IMPLANT, COCHLEAR2,771 reports
- Cochlear® Nucleus® CI622 cochlear Implant with Slim Straight electrodeCochlear Limited · Implant, cochlear2,115 reports
- Cochlear® Nucleus® CI632 cochlear Implant with Slim Modiolar electrodeCochlear Limited · Implant, cochlear2,057 reports
- Nucleus Z60353Cochlear Limited · IMPLANT, COCHLEAR2 deaths1,815 reports
- Cochlear® Nucleus® CI522 cochlear Implant with Slim Straight electrodeCochlear Limited · IMPLANT, COCHLEAR1,475 reports
- Cochlear® Nucleus® CI612 cochlear ImplantCochlear Limited · Implant, cochlear1,150 reports
- Nucleus Z190574Cochlear Limited · IMPLANT, COCHLEAR981 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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