—#194644

Product

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 product code: QEY — Mechanical Thrombolysis Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K213422
Affected lot / code info: UPN: 500-56112 GTIN: 858593006264 Lot Numbers: 8035075263, 8035075264, 8035075265, 8035075266, 8035075267, 8035075268, 8035075269, 8035075270, 8035075271, 8035075272

Why it was recalled

Product may be mislabeled.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 1 Scimed Pl, Maple Grove, Minnesota 55311-1565

Distribution

Distribution pattern: US distribution only - CA, CT, GA, IA, IL, IN, NY, OH, TX, WY

Timeline

Recall initiated: 2022-05-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #194644. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.