Reported Feb 20, 2019 · Ongoing
Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED01 (b) Model Number…
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 generatorSENSIA
- Dual chamber pacemaker (DDD)(a) Model Number SED01 (b) Model Number SEDR01 (c) Model Number SEDRL1
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published 00643169708914Model Number SED01, , All Serial Numbers (b) 006431697088770064316970889100643169969780Model Number SEDR01, , 00643169708891, 00643169969780, All Serial Numbers (c) 00643169708907Model Number SEDRL1, , All Serial Numbers - Amount recalled
- 59232 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Medtronic Inc., Cardiac Rhythm and Heart… recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.