Reported Apr 7, 2021 · Ongoing
Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S…
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?
- Implantable
- cardioverter defibrillators (ICD)1)
- Evera familyEvera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S DR, Evera XT VR, Evera S VR and Evera MRI S VR models; 2)
- Visia familyVisia AF ICD, Visia AF S ICD, Visia AF MRI ICD, and Visia AF MRI S ICD models. Implantable Cardioverter Defibrillators (ICDs) are implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia
- Lot codes and dates
- 1)
- Evera FamilyMODEL
- NUMBER / NAME / GTINSERIAL
- NUMBERSDDBB1D1 / ICD-DR DDBB1D1
- EVERA XT US IS1/DF1 / 00643169018099
2,706 of 2,706 codes
BWC231766HBWC230184HBWC230891HBWC228489HBWC232037HBWC230770HBWC231219HBWC231215HBWC231190HBWC231202HBWC231199HBWC231780HBWC231556HBWC230255HBWC230772HBWC230906HBWC231500HBWC231572HBWC231618HBWC231655HBWC231937HBWC231942HBWC230859HBWC230949HBWC231848HBWC230918HBWC231237HBWC231580HBWC230893HBWC231576HBWC230426HBWC230475HBWC230431HBWC231494HBWC230876HBWC230776HBWC228873HBWC229321HBWC230873HBWC229698HBWC230449HBWC231452HBWC230877HBWC230720HBWC231479HBWC231482HBWC231578HBWC231498HBWC229796HBWC230863HBWC230874HBWC231239HBWC230917HBWC229337HBWC230524HBWC230887HBWC231525HBWC231240HBWC230672HBWC230769H
- Amount recalled
- 290086 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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