Device product

Amplatzer Steerable Delivery Sheath

Z-0895-2022

November 09, 2021

Class II

Product summary

Firm: Abbott
Event: Event 89714
Status: Terminated
Classification: Class II
Quantity: 529 units
Official record key: device-enforcement:Z-0895-2022

Official wording

Reason: Instructions for use were updated.

Code information: Model ASDS-14F-075, Batch Numbers: 1) 7963817 2) 7976534 3) 7981029 4) 7990340 5) 8008111 6) 8010056 7) 8025120 8) 8102214 9) 8106240 10) 8234848 11) 8274323 12) 8277741

Distribution pattern: OUS distribution only

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Instructions for use were updated.