FDAOctober 16, 2018device
MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following implant types: a. Mil000 CONCERTO PIN +FLEX28; b. Mi1000 CONCERTO +FLEX28; c. Mi1000 CONCERTO PIN +FLEXsoft; d. Mil000 CONCERTO +Standard; e. Mil000 CONCERTO +Medium; f. Mi1000 CONCERTO PIN +Standard; g. M11000 CONCE...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
What to do
FDA enforcement status: Terminated
Brands named
med el elektromedizinische gereatemedmed el
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAAdvance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-282026-05-27
- FDADORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)2025-03-14
- FDASUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use only to remove excess fluid from the surgical field.2024-11-19
- FDAhuman med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.2024-10-18
- FDABrand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: ROLLING WALKER MOBILITY AID2024-08-26
- FDABrand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL Product Description: ROLLING WALKER MOBILITY AID2024-08-26
- FDABrand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model/Catalog Number: 4329PL Product Description: ROLLING WALKER MOBILITY AID2024-08-26
- FDAMi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant2024-04-18
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