EkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed into the respective trays and sealed in a Tyvek pouch. The sealed pouches are placed inside the kit carton (box) and the product labels.
FDA Recall Z-1491-2022 · Posted None
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Recalling FirmBoston Scientific Corporation
Recall StatusOpen, Classified
Product CodeQEY
Date Initiated2022-05-25
Product Quantity10 units
Reason for Recall
Product may be mislabeled.
Firm Action
The recalling firm notified affected consignees by telephone beginning May 25, 2022 to inform them of the potential of improperly packaged devices. On May 26, 2022, customer notifications, including a letter, instructions and reply form) were sent to all affected accounts via FedEx Overnight Delivery.
Consignees are asked to return any affected and unused devices to BSC. The field removal letter will provide customers with the product segregation and return instructions and accounts are asked to complete a Reply Verification Tracking Form (RVTF) indicating they have received the field removal and followed the included instructions.
Root Cause
Under Investigation by firm
Distribution Pattern
US distribution only - CA, CT, GA, IA, IL, IN, NY, OH, TX, WY
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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