EkoSonic recallZ-1491-2022 · Boston Scientific Corporation · initiated May 25, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product may be mislabeled.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1491-2022
- Status
- Open, Classified
- Initiated by the company
- May 25, 2022
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 10 units
- Product code
- QEY
- FDA submissions
- K213422
- Distribution
- US distribution only - CA, CT, GA, IA, IL, IN, NY, OH, TX, WY
Product description
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.
Code information (models, lots, serial numbers)
UPN: 500-56112 GTIN: 858593006264 Lot Numbers: 8035075263, 8035075264, 8035075265, 8035075266, 8035075267, 8035075268, 8035075269, 8035075270, 8035075271, 8035075272
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EkoSonic® 6795-002Boston Scientific Corporation · Catheter, Continuous Flush1 recall13 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 90528).
- Z-1492-2022 · Open, ClassifiedEkoSonic Kit 106cm, 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 se…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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