Boston Scientific Corporation: Medical Device Recall in 2022 - (Recall #: Z-1491-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 25, 2022

Date Posted: August 10, 2022

Recall Number: Z-1491-2022

Event ID: 90528

Reason for Recall:

Product may be mislabeled.

Status: Ongoing

Product Quantity: 10 units

Code Information:

UPN: 500-56112 GTIN: 858593006264 Lot Numbers: 8035075263, 8035075264, 8035075265, 8035075266, 8035075267, 8035075268, 8035075269, 8035075270, 8035075271, 8035075272

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated