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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-0582-2018 - Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Labeled as the following:
a. Amplia MRI CRT-D DF4 (Product No. DTMB1D4);
b. Amplia MRI Quad CRT-D DF1 (Product No. DTMB1Q1)...
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1
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02/01/2018
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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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Z-0583-2018 - Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI. Labeled as the following:
a. Compia MRI CRT-D DF1 (Product No. DTMC1D1);
b. Compia MRI Quad CRT-D DF4 (Product No.DTMC1QQ ...
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1
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02/01/2018
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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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Z-0584-2018 - 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....
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1
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02/01/2018
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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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Z-0589-2018 - Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as:
a. Visia AF VR ICD DF1 (Product No. DVAB1D1);
EXPANSION:
b. Visia AF" VR ICD DF4 (Product No. DVAB1D4)
Implantable ...
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1
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02/01/2018
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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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Z-0586-2018 - Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Labeled as the following:
a. Claria MRI CRT-D DF1 (Product No. DTMA1D1);
b. Claria MRI Quad CRT-D DF4 (Product No. DTMA1QQ)...
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1
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02/01/2018
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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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Z-0587-2018 - Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the following:
a. Evera S DR ICD DF1 (Product No. DDBC3D1);
b. Evera S VR ICD DF1 (Product No. DVBC3D1);
c. Evera S VR ICD DF4...
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1
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02/01/2018
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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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Z-0588-2018 - Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the following:
a. Visia AF MRI VR SureScan ICD DF1 (Product No. DVFB1D1);
b. Visia AF MRI VR SureScan ICD DF4 (Product No....
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1
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02/01/2018
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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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Z-0585-2018 - Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the following:
a. Evera MRI XT DR ICD DF1 (Product No. DDMB1D1);
b. Evera MRI XT DR ICD DF4 (Product No. DDMB1D4);
c. Ev...
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1
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02/01/2018
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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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