Programmers - 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. 1. 2090 Carelink 2. 29901 Encore
Reported: May 12, 2021 Initiated: April 6, 2021 #Z-1527-2021
Product Description
Programmers - 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. 1. 2090 Carelink 2. 29901 Encore
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
- 37690 units
- Distribution
- Worldwide distribution.
- Location
- Mounds View, MN
Frequently Asked Questions
What product was recalled? ▼
Programmers - 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. 1. 2090 Carelink 2. 29901 Encore. Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF). Units affected: 37690 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-1527-2021.
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