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Coaptite
MERZ NORTH AMERICA, INC. · Model 8005P10 · UDI-DI 08714729804796
LNM
Prescription
0
510(k) clearances
1,167
Adverse events (8 deaths)
3
Recalls
18
Facilities
Description
The Coaptite Injectable Implant is a permanently implanted device used to treat women who have severe stress urinary incontinence due to poorly functioning urethral sphincter muscles.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-06-03 | Axonics Modulation Technologies, Inc. | Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized |
| 2020-09-30 | Merz North America, Inc. | The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study. |
| 2005-09-23 | Boston Scientific Corporation | Incorrect implantation may cause serious health complications |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.