Reported Feb 20, 2019 · Ongoing
Medtronic implantable pulse generator
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?
Medtronic implantable pulse generator
7 of 7 products
| Model / number | Product as published |
|---|---|
ADD01 | (b) |
ADDR01 | (c) |
ADDR03 | (d) |
ADDR06 | (e) |
ADDRL1 | (f) |
ADDRS1 | (g) |
ADVDD01 | — |
- Lot codes and dates
7 of 7 products
Products covered by this recall Model / number Barcodes Product as published 00643169708754Model Number ADD01, , All Serial Numbers (b) 006431697085870064316970859400643169708600064316970862400643169969711Model Number ADDR01, , 00643169708594, 00643169708600, 0643169708624, 00643169969711, All Serial Numbers (c) 0064316970863100643169708648Model Number ADDR03, , 00643169708648, All Serial Numbers (d) 0064316970865500643169708662Model Number ADDR06, , 00643169708662, All Serial Numbers (e) 0064316951824700643169708679006431697086860064316970870900643169969803Model Number ADDRL1, , 00643169708679, 00643169708686, 00643169708709, 00643169969803, All Serial Numbers (f) 0064316970871600643169708723006431697087300064316970874700643169969810Model Number ADDRS1, , 00643169708723, 00643169708730, 00643169708747, 00643169969810, All Serial Numbers (g) 006431697087610064316970877800643169969735Model Number ADVDD01, , 00643169708778, 00643169969735, All Serial Numbers - Amount recalled
- 41802 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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