Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00795-1
Product Name/Description Encore 26 Inflation Device Single Pack

UPN: H74904526011, M001151050, M00566670 and M0067101140

Multiple Lot Numbers

ARTG Number: 137086
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 21/06/2017
Responsible Entity Boston Scientific Pty Ltd
Reason/Issue Boston Scientific has received reports of cracking with specific lots of Encore 26 Inflation Device single packs. The device trays from these lots have the potential to crack under certain handling conditions, such as impact during shipment. This issue has been attributed to a change in the material used in the packaging process. Use of an Encore device with a cracked device tray during a procedure could result in patient infection if used within the sterile field. To date, no reports of patient harm have been received.
Recall Action Recall
Recall Action Instructions Boston Scientific is requesting that Customers:
1. Immediately check inventory and identify whether there are products with UPNs and lot numbers listed in Attachment 1 of the customer letter;
2. Inspect the device tray in the area highlighted above. If you identify any units with a cracked tray in your supply, immediately discontinue use and segregate affected units in a secure location; and
3. Complete the Reply Verification Tracking Form detailing identified affected units.

This action has been closed out on 18/09/2018
Contact Information 02 8063 8181 Boston Scientific