Reported Feb 28, 2018 · Terminated
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as the following
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?
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as the following
8 of 8 products
| # | Product as published |
|---|---|
| 1 | Viva Quad S CRT-D DF4 (Product No. DTBB1QQ) |
| 2 | Viva Quad XT CRT-D DF4 (Product No. DTBA1QQ) |
| 3 | Viva S CRT-D DF1 (Product No. DTBB1D1) |
| 4 | Viva XT CRT-D DF1 (Product No. DTBA1D1) |
| 5 | Viva XT CRT-D DF4 (Product No. DTBA1D4); EXPANSION |
| 6 | Viva Quad S CRT-D DF1 (Product No. DTBB1Q1) |
| 7 | Viva Quad XT CRT-D DF1 (Product No. DTBA1Q1) |
| 8 | Viva S CRT-D DF4 (Product No. DTBB1D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices). |
- Lot codes and dates
- a. Product No
- DTBB1QQUDI 00643169530218 (Serial No
- BLK204122H) (EXPANSION
Serial No. BLK202087HBLK203257HBLK204050HBLK204435H)b. Product No
- DTBA1QQUDI 00643169007222 (Serial No
- BLC224272H) (EXPANSION
Serial No. BLC200490HBLC205825HBLC205826HBLC205827HBLC206202HBLC206263HBLC208305HBLC208471HBLC211869HBLC215219HBLC215544HBLC218906HBLC219515HBLC220190HBLC221044HBLC221045HBLC221046HBLC221047HBLC222903HBLC223278HBLC223517HBLC224374HBLC224553HBLC224554HBLC224555HBLC224556HBLC224655HBLC225498HBLC225502HBLC225682HBLC225734HBLC226030HBLC226031HBLC226032HBLC226033HBLC226034HBLC226035HBLC226040HBLC227270HBLC227659HBLC227662HBLC205767HBLC205828HBLC211870HBLC226988HBLC227212HBLC227728HBLC227740H)00643169530171 (Serial No. BLC227175HBLC227641H)c. Product No
- DTBB1D1UDI 00643169007185 (Serial No
- BLO204984H) EXPANSION
Serial No. BLO210650HBLO212502HBLO201695HBLO204429HBLO206930HBLO207702HBLO208974HBLO210408HBLO210409HBLO210770HBLO212131HBLO212481HBLO212491HBLO212493HBLO212503HBLO212504HBLO212505HBLO212506HBLO212507HBLO212729HBLO213454HBLO213467HBLO213468HBLO213592HBLO213780HBLO213781HBLO201347HBLO201436HBLO208063HBLO212501HBLO213783HBLO213784HBLO213786H)d. Product No
- DTBA1D1
UDI 00643169530140 (Serial No. BLF253790HBLF254092HBLF250740HBLF251155H)00643169007246 (Serial No. BLF216780H
- BLF231229H) (EXPANSION
107 of 107 codes
Serial No. BLF243217HBLF247858HBLF202387HBLF202535HBLF204112HBLF205853HBLF206730HBLF206788HBLF207518HBLF207678HBLF210779HBLF210782HBLF211003HBLF211357HBLF211358HBLF213450HBLF213658HBLF218473HBLF219583HBLF219667HBLF221248HBLF222061HBLF224098HBLF224106HBLF224214HBLF224230HBLF224242HBLF224253HBLF224260HBLF224386HBLF224483HBLF227680HBLF227903HBLF227947HBLF228849HBLF230968HBLF232235HBLF232254HBLF234692HBLF235138HBLF237753HBLF238241HBLF238700HBLF239221HBLF239916HBLF243268HBLF243674HBLF245571HBLF245572HBLF245893HBLF246563HBLF247381HBLF247435HBLF247466HBLF248396HBLF248398HBLF248399HBLF248400HBLF248401HBLF248402H
- DTBA1D4
UDI 00643169530157 (Serial No. BLE219903H)00643169929302 (Serial No. BLE220200H)
- EXPANSION
UDI 00643169007239 (Serial No. BLE205339HBLE203253HBLE203582HBLE203583HBLE204049HBLE205304HBLE209377HBLE209554HBLE212368HBLE213926HBLE218673HBLE218892HBLE218902HBLE219909HBLE219911HBLE219914HBLE208468HBLE204048HBLE214123HBLE217805HBLE219910HBLE220390HBLE219912H)
- EXPANSIONf. Product No
- DTBB1Q1
UDI 00643169017993 (Serial No. BLM201868HBLM202644HBLM202773HBLM202775H)g. Product No
- DTBA1Q1
UDI 00643169018013 (Serial NoBLD202507HBLD202778HBLD203541HBLD207024HBLD208443HBLD209856HBLD210102HBLD210103HBLD210175HBLD210220HBLD210223HBLD210251HBLD210257HBLD210258HBLD210259HBLD210260HBLD211370HBLD211371HBLD211681HBLD211682HBLD202666HBLD210700HBLD210738HBLD211680HBLD210699H)h. Product No
- DTBB1D4
UDI 00643169007178 (Serial No. BLN201692HBLN201722HBLN202203HBLN202897HBLN204159HBLN202355H)
- Amount recalled
- 951 devices total
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Using this product could cause serious injury, illness or death — stop using it now.
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