Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as the following: a. Viva Quad S CRT-D DF4 (Product No. DTBB1QQ); b. Viva Quad XT CRT-D DF4 (Product No. DTBA1QQ); c. Viva S CRT-D DF1 (Product No. DTBB1D1); d. Viva XT CRT-D DF1 (Product No. DTBA1D1); e. Viva XT CRT-D DF4 (Product No. DTBA1D4); EXPANSION: f. Viva Quad S CRT-D DF1 (Product No. DTBB1Q1); g. Viva Quad XT CRT-D DF1 (Product No. DTBA1Q1); h. 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).
Class I - DangerousWhat Should You Do?
- Check if you have this product: a. Product No. DTBB1QQ: UDI 00643169530218 (Serial No. BLK204122H) (EXPANSION: Serial No. BLK202087H, BLK203257H, BLK204050H, BLK204435H); b. Product No. DTBA1QQ: UDI 00643169007222 (Serial No. BLC224272H) (EXPANSION: Serial No. BLC200490H, BLC205825H, BLC205826H, BLC205827H, BLC206202H, BLC206263H, BLC208305H, BLC208471H, BLC211869H, BLC215219H, BLC215544H, BLC218906H, BLC219515H, BLC220190H, BLC221044H, BLC221045H, BLC221046H, BLC221047H, BLC222903H, BLC223278H, BLC223517H, BLC224374H, BLC224553H, BLC224554H, BLC224555H, BLC224556H, BLC224655H, BLC225498H, BLC225502H, BLC225682H, BLC225734H, BLC226030H, BLC226031H, BLC226032H, BLC226033H, BLC226034H, BLC226035H, BLC226040H, BLC227270H, BLC227659H, BLC227662H, BLC205767H, BLC205828H, BLC211870H, BLC226988H, BLC227212H, BLC227728H, BLC227740H), 00643169530171 (Serial No. BLC227175H, BLC227641H); c. Product No. DTBB1D1: UDI 00643169007185 (Serial No. BLO204984H) EXPANSION: Serial No. BLO210650H, BLO212502H, BLO201695H, BLO204429H, BLO206930H, BLO207702H, BLO208974H, BLO210408H, BLO210409H, BLO210770H, BLO212131H, BLO212481H, BLO212491H, BLO212493H, BLO212503H, BLO212504H, BLO212505H, BLO212506H, BLO212507H, BLO212729H, BLO213454H, BLO213467H, BLO213468H, BLO213592H, BLO213780H, BLO213781H, BLO201347H, BLO201436H, BLO208063H, BLO212501H, BLO213783H, BLO213784H, BLO213786H); d. Product No. DTBA1D1: UDI 00643169530140 (Serial No. BLF253790H, BLF254092H, BLF250740H, BLF251155H), 00643169007246 (Serial No. BLF216780H, BLF231229H) (EXPANSION: Serial No. BLF243217H, BLF247858H, BLF202387H, BLF202535H, BLF204112H, BLF205853H, BLF206730H, BLF206788H, BLF207518H, BLF207678H, BLF210779H, BLF210782H, BLF211003H, BLF211357H, BLF211358H, BLF213450H, BLF213658H, BLF218473H, BLF219583H, BLF219667H, BLF221248H, BLF222061H, BLF224098H, BLF224106H, BLF224214H, BLF224230H, BLF224242H, BLF224253H, BLF224260H, BLF224386H, BLF224483H, BLF227680H, BLF227903H, BLF227947H, BLF228849H, BLF230968H, BLF232235H, BLF232254H, BLF234692H, BLF235138H, BLF237753H, BLF238241H, BLF238700H, BLF239221H, BLF239916H, BLF243268H, BLF243674H, BLF245571H, BLF245572H, BLF245893H, BLF246563H, BLF247381H, BLF247435H, BLF247466H, BLF248396H, BLF248398H, BLF248399H, BLF248400H, BLF248401H, BLF248402H, BLF248403H, BLF248464H, BLF249952H, BLF250022H, BLF250142H, BLF250143H, BLF250389H, BLF250392H, BLF250393H, BLF250751H, BLF251380H, BLF253085H, BLF253406H, BLF253407H, BLF253618H, BLF253795H, BLF253796H, BLF253798H, BLF253801H, BLF253802H, BLF253803H, BLF253806H, BLF253820H, BLF253853H, BLF254774H, BLF254776H, BLF254777H, BLF254778H, BLF254779H, BLF200834H, BLF205341H, BLF218472H, BLF218474H, BLF220892H, BLF224264H, BLF250752H, BLF205821H, BLF210550H, BLF222642H, BLF251852H, BLF253755H, BLF253852H, BLF253797H, BLF253799H), 00643169929296 (Serial No. BLF255165H, BLF255598H; e. Product No. DTBA1D4: UDI 00643169530157 (Serial No. BLE219903H), 00643169929302 (Serial No. BLE220200H), EXPANSION: UDI 00643169007239 (Serial No. BLE205339H, BLE203253H, BLE203582H, BLE203583H, BLE204049H, BLE205304H, BLE209377H, BLE209554H, BLE212368H, BLE213926H, BLE218673H, BLE218892H, BLE218902H, BLE219909H, BLE219911H, BLE219914H, BLE208468H, BLE204048H, BLE214123H, BLE217805H, BLE219910H, BLE220390H, BLE219912H); EXPANSION: f. Product No. DTBB1Q1: UDI 00643169017993 (Serial No. BLM201868H, BLM202644H, BLM202773H, BLM202775H); g. Product No. DTBA1Q1: UDI 00643169018013 (Serial No, BLD202507H, BLD202778H, BLD203541H, BLD207024H, BLD208443H, BLD209856H, BLD210102H, BLD210103H, BLD210175H, BLD210220H, BLD210223H, BLD210251H, BLD210257H, BLD210258H, BLD210259H, BLD210260H, BLD211370H, BLD211371H, BLD211681H, BLD211682H, BLD202666H, BLD210700H, BLD210738H, BLD211680H, BLD210699H); h. Product No. DTBB1D4: UDI 00643169007178 (Serial No. BLN201692H, BLN201722H, BLN202203H, BLN202897H, BLN204159H, BLN202355H)
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Reason for Recall:
- Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as the following: a. Viva Quad S CRT-D DF4 (Product No. DTBB1QQ); b. Viva Quad XT CRT-D DF4 (Product No. DTBA1QQ); c. Viva S CRT-D DF1 (Product No. DTBB1D1); d. Viva XT CRT-D DF1 (Product No. DTBA1D1); e. Viva XT CRT-D DF4 (Product No. DTBA1D4); EXPANSION: f. Viva Quad S CRT-D DF1 (Product No. DTBB1Q1); g. Viva Quad XT CRT-D DF1 (Product No. DTBA1Q1); h. 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).
Product Codes/Lot Numbers:
a. Product No. DTBB1QQ: UDI 00643169530218 (Serial No. BLK204122H) (EXPANSION: Serial No. BLK202087H, BLK203257H, BLK204050H, BLK204435H); b. Product No. DTBA1QQ: UDI 00643169007222 (Serial No. BLC224272H) (EXPANSION: Serial No. BLC200490H, BLC205825H, BLC205826H, BLC205827H, BLC206202H, BLC206263H, BLC208305H, BLC208471H, BLC211869H, BLC215219H, BLC215544H, BLC218906H, BLC219515H, BLC220190H, BLC221044H, BLC221045H, BLC221046H, BLC221047H, BLC222903H, BLC223278H, BLC223517H, BLC224374H, BLC224553H, BLC224554H, BLC224555H, BLC224556H, BLC224655H, BLC225498H, BLC225502H, BLC225682H, BLC225734H, BLC226030H, BLC226031H, BLC226032H, BLC226033H, BLC226034H, BLC226035H, BLC226040H, BLC227270H, BLC227659H, BLC227662H, BLC205767H, BLC205828H, BLC211870H, BLC226988H, BLC227212H, BLC227728H, BLC227740H), 00643169530171 (Serial No. BLC227175H, BLC227641H); c. Product No. DTBB1D1: UDI 00643169007185 (Serial No. BLO204984H) EXPANSION: Serial No. BLO210650H, BLO212502H, BLO201695H, BLO204429H, BLO206930H, BLO207702H, BLO208974H, BLO210408H, BLO210409H, BLO210770H, BLO212131H, BLO212481H, BLO212491H, BLO212493H, BLO212503H, BLO212504H, BLO212505H, BLO212506H, BLO212507H, BLO212729H, BLO213454H, BLO213467H, BLO213468H, BLO213592H, BLO213780H, BLO213781H, BLO201347H, BLO201436H, BLO208063H, BLO212501H, BLO213783H, BLO213784H, BLO213786H); d. Product No. DTBA1D1: UDI 00643169530140 (Serial No. BLF253790H, BLF254092H, BLF250740H, BLF251155H), 00643169007246 (Serial No. BLF216780H, BLF231229H) (EXPANSION: Serial No. BLF243217H, BLF247858H, BLF202387H, BLF202535H, BLF204112H, BLF205853H, BLF206730H, BLF206788H, BLF207518H, BLF207678H, BLF210779H, BLF210782H, BLF211003H, BLF211357H, BLF211358H, BLF213450H, BLF213658H, BLF218473H, BLF219583H, BLF219667H, BLF221248H, BLF222061H, BLF224098H, BLF224106H, BLF224214H, BLF224230H, BLF224242H, BLF224253H, BLF224260H, BLF224386H, BLF224483H, BLF227680H, BLF227903H, BLF227947H, BLF228849H, BLF230968H, BLF232235H, BLF232254H, BLF234692H, BLF235138H, BLF237753H, BLF238241H, BLF238700H, BLF239221H, BLF239916H, BLF243268H, BLF243674H, BLF245571H, BLF245572H, BLF245893H, BLF246563H, BLF247381H, BLF247435H, BLF247466H, BLF248396H, BLF248398H, BLF248399H, BLF248400H, BLF248401H, BLF248402H, BLF248403H, BLF248464H, BLF249952H, BLF250022H, BLF250142H, BLF250143H, BLF250389H, BLF250392H, BLF250393H, BLF250751H, BLF251380H, BLF253085H, BLF253406H, BLF253407H, BLF253618H, BLF253795H, BLF253796H, BLF253798H, BLF253801H, BLF253802H, BLF253803H, BLF253806H, BLF253820H, BLF253853H, BLF254774H, BLF254776H, BLF254777H, BLF254778H, BLF254779H, BLF200834H, BLF205341H, BLF218472H, BLF218474H, BLF220892H, BLF224264H, BLF250752H, BLF205821H, BLF210550H, BLF222642H, BLF251852H, BLF253755H, BLF253852H, BLF253797H, BLF253799H), 00643169929296 (Serial No. BLF255165H, BLF255598H; e. Product No. DTBA1D4: UDI 00643169530157 (Serial No. BLE219903H), 00643169929302 (Serial No. BLE220200H), EXPANSION: UDI 00643169007239 (Serial No. BLE205339H, BLE203253H, BLE203582H, BLE203583H, BLE204049H, BLE205304H, BLE209377H, BLE209554H, BLE212368H, BLE213926H, BLE218673H, BLE218892H, BLE218902H, BLE219909H, BLE219911H, BLE219914H, BLE208468H, BLE204048H, BLE214123H, BLE217805H, BLE219910H, BLE220390H, BLE219912H); EXPANSION: f. Product No. DTBB1Q1: UDI 00643169017993 (Serial No. BLM201868H, BLM202644H, BLM202773H, BLM202775H); g. Product No. DTBA1Q1: UDI 00643169018013 (Serial No, BLD202507H, BLD202778H, BLD203541H, BLD207024H, BLD208443H, BLD209856H, BLD210102H, BLD210103H, BLD210175H, BLD210220H, BLD210223H, BLD210251H, BLD210257H, BLD210258H, BLD210259H, BLD210260H, BLD211370H, BLD211371H, BLD211681H, BLD211682H, BLD202666H, BLD210700H, BLD210738H, BLD211680H, BLD210699H); h. Product No. DTBB1D4: UDI 00643169007178 (Serial No. BLN201692H, BLN201722H, BLN202203H, BLN202897H, BLN204159H, BLN202355H)
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0584-2018
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