Reported Feb 20, 2019 · Ongoing
vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b) E-series, Model Numbers: E50A1,…
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · 8200 Coral Sea St Ne · Mounds View, MN · 55112-4391
Is this the product you have?
- vitatron (implantable pulse generator)(a) A-series
- Model Numbers
A30A1A60A1 (b) E-series
- Model Numbers
E50A1E60A1 (c) G-series
- Model Numbers
G70A1G70A2 (d) Q-series
- Model Numbers
Q50A2Q70A2Q80A2
- Lot codes and dates
6 of 6 products
Products covered by this recall Model / number Barcodes Product as published 00643169709331(a) A-series, Model Number: A30A1 006431697091260064316970929400643169709140A60A1, GTIN 00643169709294, All Serial Numbers (b) E-series, Model Number: E50A1, , 00643169709140 00643169709249006431697091640064316970918800643169709263E60A1, GTIN 00643169709164, 00643169709188, All Serial Numbers (c) G-series, Model Numbers: G70A1, , 00643169709263 0064316988301700643169883000G70A2, GTIN 00643169883000, All Serial Numbers (d) Q-series, Model Number: Q50A2 00643169882980Q70A2 00643169882997Q80A2, , All Serial Numbers - Amount recalled
- 47086 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Why it was recalled
Stop using this product now
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
Using this product could cause serious injury, illness or death — stop using it now.
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