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AMS Ambicor
BOSTON SCIENTIFIC CORPORATION · Model 72401457 · UDI-DI 00878953001012
FHW
Prescription
0
510(k) clearances
38,562
Adverse events (9 deaths)
20
Recalls
7
Facilities
Description
Inflatable Penile Prosthesis
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-03-01 | Coloplast Manufacturing US, LLC | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to i |
| 2023-03-01 | Coloplast Manufacturing US, LLC | XXX |
| 2023-03-01 | Coloplast Manufacturing US, LLC | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to i |
| 2023-03-01 | Coloplast Manufacturing US, LLC | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to i |
| 2023-03-01 | Coloplast Manufacturing US, LLC | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to i |
| 2023-03-01 | Coloplast Manufacturing US, LLC | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to i |
| 2023-03-01 | Coloplast Manufacturing US, LLC | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to i |
| 2023-03-01 | Coloplast Manufacturing US, LLC | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to i |
| 2023-03-01 | Coloplast Manufacturing US, LLC | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to i |
| 2023-03-01 | Coloplast Manufacturing US, LLC | A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to i |
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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.