vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b) E-series, Model Numbers: E50A1, E60A1 (c) G-series, Model Numbers: G70A1, G70A2 (d) Q-series, Model Numbers: Q50A2, Q70A2, Q80A2
Reported: February 20, 2019 Initiated: January 17, 2019 #Z-0812-2019
Product Description
vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b) E-series, Model Numbers: E50A1, E60A1 (c) G-series, Model Numbers: G70A1, G70A2 (d) Q-series, Model Numbers: Q50A2, Q70A2, Q80A2
Reason for Recall
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality
Details
- Recalling Firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Units Affected
- 47086 units
- Distribution
- Wordlwide
- Location
- Mounds View, MN
Frequently Asked Questions
What product was recalled? ▼
vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b) E-series, Model Numbers: E50A1, E60A1 (c) G-series, Model Numbers: G70A1, G70A2 (d) Q-series, Model Numbers: Q50A2, Q70A2, Q80A2. Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF). Units affected: 47086 units.
Why was this product recalled? ▼
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 20, 2019. Severity: Critical. Recall number: Z-0812-2019.
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