CDSCO issues medical device alert for Cordis Palmaz Genesis Peripheral Stent

Published On 2022-06-27 12:00 GMT   |   Update On 2022-06-27 12:01 GMT

In line with the Risk Assessment Form released by Cordis Cashel, Ireland, the Central Drugs Standard Control Organization (CDSCO) has issued a Medical Device Alert for PALMAZ GENESIS Peripheral Stent on OPTA PRO .035" Delivery System (PG2990PPX-82178943, PG2990PPX-82211305, PG3990PPS-82182764, PG3990PPX-82212989, PG3990PPX- 82218097).This Medical Device Alert comes after Cordis...

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In line with the Risk Assessment Form released by Cordis Cashel, Ireland, the Central Drugs Standard Control Organization (CDSCO) has issued a Medical Device Alert for PALMAZ GENESIS Peripheral Stent on OPTA PRO .035" Delivery System (PG2990PPX-82178943, PG2990PPX-82211305, PG3990PPS-82182764, PG3990PPX-82212989, PG3990PPX- 82218097).

This Medical Device Alert comes after Cordis released Distributed Product Risk Assessment Form dated 18.05.2022 indicating increased complaint rate for stent dislodgement.

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CDSCO Issues Medical Device Alert For Cordis Palmaz Genesis Peripheral Stent

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