CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure, Model Number 24970A
Reported: May 12, 2021 Initiated: April 6, 2021 #Z-1528-2021
Product Description
CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure, Model Number 24970A
Reason for Recall
A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.
Details
- Recalling Firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Units Affected
- 16,311 units
- Distribution
- Worldwide distribution.
- Location
- Mounds View, MN
Frequently Asked Questions
What product was recalled? ▼
CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure, Model Number 24970A. Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF). Units affected: 16,311 units.
Why was this product recalled? ▼
A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 12, 2021. Severity: Moderate. Recall number: Z-1528-2021.
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