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Terminated

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

FDA Recall Z-3043-2017 · Posted None

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeMAV
Date Initiated2017-06-15
Date Terminated2020-07-22
Product Quantity305,779 units

Reason for Recall

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

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

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K955869SCIMED ENCORE 26 INFLATION DEVICE/ENCORE 30 INFLATION DEVICEScimed Life Systems, Inc. · 1996-03-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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