Recall Z-3043-2017— Boston Scientific Corporation

Name: FDA recall Z-3043-2017
Creator: U.S. Food and Drug Administration
Published: 2017-06-15

Class II · Terminated

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2017-06-15, terminated 2020-07-22. It names one FDA 510(k) clearance: K955869. Product: Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c) M00566670, (d) M0067101140. Reason: Boston Scientific (BSC) has received complaints for cracked trays on the Encore device..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-06-15
Terminated: 2020-07-22
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K955869 — SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICEScimed Life Systems, Inc.·cleared 1996-03-22

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

Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c) M00566670, (d) M0067101140

Reason for recall

Boston Scientific (BSC) has received complaints for cracked trays on the Encore device.

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