Recall Z-1491-2022— Boston Scientific Corporation

Name: FDA recall Z-1491-2022
Creator: U.S. Food and Drug Administration
Published: 2022-05-25

Class II · Ongoing

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2022-05-25. It names one FDA 510(k) clearance: K213422. 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.. Reason: Product may be mislabeled..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Ongoing
Initiated: 2022-05-25
Firm location: Maple Grove, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K213422 — EkoSonic Endovascular Device, EKOS+ Endovascular DeviceBoston Scientific Corporation·cleared 2021-12-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

Product may be mislabeled.

Data sourced from openFDA. This site is unofficial and independent of the FDA.