FDA (Devices) recall action 78888

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalled 8 products on 2018-02-28

The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2018-02-28
Critical: 2
Units: 7,608

Why these products were recalled

Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–8 of 8

SevereFDA (Devices)··2018-02-28
Medtronic Recalls Claria MRI CRT-Ds Due to Therapy Prevention Risk
Medtronic is recalling 951 Claria MRI CRT-Ds because a defect may prevent the devices from delivering high or low voltage therapy.
Product
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); EXPANSION: c. Claria MRI CRT-D DF4 (Product No. DTMA1D4); d. Claria
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HighFDA (Devices)··2018-02-28
Medtronic Viva CRT-D Recall for Possible Prevention of Therapy
Medtronic is recalling 951 Viva CRT-D devices due to a potential issue that may prevent high and low voltage therapy.
Product
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. DT
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CriticalFDA (Devices)··2018-02-28
Medtronic Recalls Compia MRI CRT-Ds Due to Therapy Prevention Risk
Medtronic is recalling 951 Compia MRI CRT-Ds because a defect may prevent the delivery of high and low voltage therapy.
Product
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 ) Implantable devices that automatically detect and treat episodes of ventric
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SevereFDA (Devices)··2018-02-28
Medtronic Visia AF ICDs Recalled for Potential Therapy Failure
Medtronic is recalling 951 Visia AF ICDs and CRT-Ds because they may fail to deliver high or low voltage therapy.
Product
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 devices that automatically detect and treat episodes of ventricular fibrillation
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CriticalFDA (Devices)··2018-02-28
Medtronic Recalls Evera ICDs Due to Possible Therapy Prevention
Medtronic is recalling 951 Evera ICDs and CRT-Ds because a defect may prevent the devices from delivering high or low voltage therapy.
Product
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 (Product No. DVBC3D4); d. Evera XT DR ICD DF1 (Product No. DDBB1D1); e. E
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SevereFDA (Devices)··2018-02-28
Medtronic Recalls Amplia MRI CRT-D Devices Due to Therapy Prevention Risk
Medtronic is recalling 951 Amplia MRI CRT-D devices because they may fail to deliver high or low voltage therapy.
Product
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); c. Amplia MRI Quad CRT-D DF4 (Product No. DTMB1QQ); EXPANSION: d. Am
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HighFDA (Devices)··2018-02-28
Medtronic Recalls 951 Evera MRI ICDs Due to Therapy Prevention Risk
Medtronic is recalling 951 Evera MRI ICDs and CRT-Ds because a defect may prevent high and low voltage therapy. Patients should contact their healthcare provider.
Product
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. Evera MRI XT VR ICD DF4 (Product No. DVMB1D4); d. Evera MRI S DR ICD DF1 (Produ
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HighFDA (Devices)··2018-02-28
Medtronic Recalls Visia AF MRI ICDs Due to Therapy Prevention Risk
Medtronic is recalling 951 Visia AF MRI ICDs and CRT-Ds because a defect may prevent high and low voltage therapy.
Product
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. DVFB1D4); EXPANSION: c. Visia AF MRI S VR SureScan ICD DF1 (Product No.
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