Z-3043-2017Class II

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

Name: Z-3043-2017 Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c) M00566670, (d)...
Creator: Boston Scientific Corporation
Published: 2017-06-15
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2017-06-15 / Terminated

FDA source

Boston Scientific Corporation began a recall of Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c) M00566670, (d) M0067101140 on 2017-06-15. FDA classified it as Class II and gives the reason as "Boston Scientific (BSC) has received complaints for cracked trays on the Encore device". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3043-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-15
Posted: 2017-08-16
Terminated: 2020-07-22
Recalling firm: Boston Scientific Corporation
Product: Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c) M00566670, (d) M0067101140
Product code: MAV Syringe, Balloon Inflation
Reason for recall: Boston Scientific (BSC) has received complaints for cracked trays on the Encore device.
FDA root cause: Under Investigation by firm
Action: The firm initiated their recall on 06/15/2017 by letter delivered by Fed Ex in the US, on 06/15-29/2017 in the Americas delivered by Courier, email and hand delivery, on 06/16/2017 in Europe by DHL, on 06/16-19/2017 in the Arab Emirates and East Asia by email and hand delivery and on 06/136/2017 in Japan by hand delivery. In the notice, the firm described the problem and requested the following action: 1. Immediately check the inventory and identify whether there are products with UPNs and lot numbers affected by the recall. 2. Inspect the device tray in the area highlighted above. If any units with a cracked tray are identified in the supply, immediately discontinue use and segregate affected units in a secure location. 3. Arrange for the damaged units to be returned to Boston Scientific by completing the attached Reply Verification Tracking Form. 4. If no damage is identified, the device may be used as normal. Please complete and return the attached Reply Verification Tracking Form
Quantity in commerce: 305,779 units
Distribution: Worldwide
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3043-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3043-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-23	2017-08-16

Product code MAV

K955869Class IIScimed Encore 26 Inflation Device/encore 30 Inflation DeviceScimed Life Systems, Inc. / cleared 1996-03-22

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)