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U.S. Department of Health and Human Services

Class 2 Device Recall CareLink SmartSync Device Manager

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  Class 2 Device Recall CareLink SmartSync Device Manager see related information
Date Initiated by Firm April 06, 2021
Create Date April 30, 2021
Recall Status1 Open3, Classified
Recall Number Z-1522-2021
Recall Event ID 87654
PMA Number P890003S386 
Product Classification Pacemaker/icd/crt non-implanted components - Product Code OSR
Product CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
Code Information All serial numbers
Recalling Firm/
Manufacturer		 Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
8200 Coral Sea St Ne
Mounds View MN 55112-4391
For Additional Information Contact Technical Services
763-505-6000
Manufacturer Reason
for Recall		 There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT).
FDA Determined
Cause 2		 Software design
Action Beginning 06-APR-2021, Medtronic notified risk managers and practice managers of the field corrective action notification via 2-day UPS delivery of the consignee letter. Confirmation delivery of the consignee letter will be obtained. Medtronic Field Representatives have been instructed to begin installation of the software update. Outside the United States (OUS), communication began on 06- APR-2021 using locally approved methods. Medtronic Field Representatives will begin installation of the software update as it is available locally. Consignees were advised that Medtronic representatives can assist in installing the software update on programmers. During device interrogation with an updated programmer at implant or the next regularly scheduled clinic visit, a patients device will automatically receive the updated software. A courtesy notification will be provided to physicians. No confirmation will be required for the courtesy notification.
Quantity in Commerce 16,311 devices
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = OSR and Original Applicant = Medtronic, Inc.
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