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Recall Observatory FDA recall evidence

Device product

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

Z-1528-2021

April 06, 2021

Class II

Product summary

Firm
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Event
Event 87662
Status
Ongoing
Classification
Class II
Quantity
16,311 units
Official record key
device-enforcement:Z-1528-2021

Official wording

Reason: 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.

Code information: all codes

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.