Boston Scientific Corporation: Medical Device Recall in 2017 - (Recall #: Z-3043-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 15, 2017

Date Posted: August 23, 2017

Recall Number: Z-3043-2017

Event ID: 77820

Reason for Recall:

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

Status: Terminated

Product Quantity: 305,779 units

Code Information:

Serial Numbers: (a) 19563006, 19587644, 19623142, 19650458, 19704550, 19725489, 19769215, 20054530, 20077271, 20083051, 20127928, 20159518, 20202728, 20206930, 20242335, 20285571, 20309573, 20309574, 20336380, 20394218, 20423644, 20423645, 20456071, 20481170, 20534557 (b) 19640750, 19667072, 19704551, 19755302, 19755307, 19785021, 19808183, 20030825, 20060033, 20087896, 20117909, 20159601, 20171449, 20206929, 20233700, 20256035, 20279769, 20303751, 20336385, 20336386, 20364928, 20364929, 20364930, 20423650, 20472532, 20493563, 20507373, 20534581 (c) 20157078, 19623019, 19755304, 20056496, 20146417, 20264032, 20456079 (d) 19594194, 19717352, 19808180, 20121252, 20223176, 20336387, 20394350, 20534582

Distribution Pattern:

Worldwide

Voluntary or Mandated:

Voluntary: Firm initiated