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
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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
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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 |
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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.
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PMA Database | PMAs with Product Code = OSR
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