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U.S. Department of Health and Human Services

Class 2 Device Recall Encore(TM) 26 Inflation Device

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  Class 2 Device Recall Encore(TM) 26 Inflation Device see related information
Date Initiated by Firm June 15, 2017
Create Date August 16, 2017
Recall Status1 Terminated 3 on July 22, 2020
Recall Number Z-3043-2017
Recall Event ID 77820
510(K)Number K955869  
Product Classification Syringe, balloon inflation - Product Code MAV
Product Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c) M00566670, (d) M0067101140
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
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information Contact Nicole Pshon
763-494-1133
Manufacturer Reason
for Recall		 Boston Scientific (BSC) has received complaints for cracked trays on the Encore device.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MAV and Original Applicant = SCIMED LIFE SYSTEMS, INC.
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