Recalls / —
—#157972
Product
Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c) M00566670, (d) M0067101140
- FDA product code
- MAV — Syringe, Balloon Inflation
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K955869
- Affected lot / code info
- 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
Why it was recalled
Boston Scientific (BSC) has received complaints for cracked trays on the Encore device.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
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
Recalling firm
- Firm
- Boston Scientific Corporation
- Address
- 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234
Distribution
- Distribution pattern
- Worldwide
Timeline
- Recall initiated
- 2017-06-15
- Terminated
- 2020-07-22
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #157972. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.