Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vect
Summary
The FDA issued a Class II for Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FL by MED-EL Elektromedizinische Gereate, Gmbh. Reason: A small number of devices may have a higher probability of a crack within the internal electronics substrate which could result in a non-functional de.
Details
Source
Device Recall
External ID
Z-2356-2024
Action Date
2024-07-24
Status
Ongoing
Category
device
Product Description
Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
Lot/Code Info: a) 39541, UDI/DI 09008737395414, Serial Numbers: 859106; b) 39545, UDI/DI 09008737395452, Serial Numbers: 860731, 860782, 863380; c) 39547, UDI/DI 09008737395476, Serial Numbers: 860757, 860772, 863386
Quantity Affected: 7 devices
Reason for Recall
A small number of devices may have a higher probability of a crack within the internal electronics substrate which could result in a non-functional device.
Distribution
US, Durham, NC
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-18
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 198 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MED-EL Elektromedizinische Gereate, Gmbh) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MED-EL Elektromedizinische Gereate, Gmbh have FDA actions?
This is the only FDA action we have on record for MED-EL Elektromedizinische Gereate, Gmbh in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2356-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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