Z-1492-2022Class II

EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC...

Name: Z-1492-2022 EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC...
Creator: Boston Scientific Corporation
Published: 2022-05-25
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2022-05-25 / Open, Classified / root cause: labeling and UDI

FDA source

Boston Scientific Corporation began a recall of EkoSonic 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... on 2022-05-25. FDA classified it as Class II and gives the reason as "Product may be mislabeled". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1492-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-05-25
Posted: 2022-08-01
Recalling firm: Boston Scientific Corporation
Product: EkoSonic 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 sealed in a Tyvek pouch. The sealed pouches are placed inside the kit carton (box) and the product labels.
Product code: QEY Mechanical Thrombolysis Catheter
Reason for recall: Product may be mislabeled.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by 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.
Quantity in commerce: 10 units
Distribution: US distribution only - CA, CT, GA, IA, IL, IN, NY, OH, TX, WY
Product codes and lots: UPN: 500-55112 GTIN: 858593006134 Lot Numbers: 8035075225, 8035075226, 8035075227, 8035075228, 8035075229, 8035075230 8035075231, 8035075232, 8035075233, 8035075234

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1492-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1491-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-10	2022-08-01
Z-1492-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-10	2022-08-01

Product code QEY

K213422Class IIEkoSonic Endovascular Device, EKOS+ Endovascular DeviceBoston Scientific Corporation / cleared 2021-12-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)