International safety notice
Urgent Field Safety Notice for Cobalt XT/Cobalt/Crome ICDs/CRT-Ds/Claria MRI/Amplia MRI/Compia MRI/Viva/Brava CRT-Ds/Visia AF/Visia AF MRI/Evera/Evera MRI/Primo MRI/Mirro MRI ICDs by Medtronic Inc.
Germany / BfArM · DEU · Nov 2, 2023
Key facts
| Title | Urgent Field Safety Notice for Cobalt XT/Cobalt/Crome ICDs/CRT-Ds/Claria MRI/Amplia MRI/Compia MRI/Viva/Brava CRT-Ds/Visia AF/Visia AF MRI/Evera/Evera MRI/Primo MRI/Mirro MRI ICDs by Medtronic Inc. |
|---|---|
| Regulator | Germany / BfArM |
| Country | DEU |
| Brand | Cobalt XT/Cobalt/Crome ICDs/CRT-Ds/Claria MRI/Amplia MRI/Compia MRI/Viva/Brava CRT-Ds/Visia AF/Visia AF MRI/Evera/Evera MRI/Primo MRI/Mirro MRI ICDs |
| Manufacturer | Medtronic Inc. |
| Models | 1895-1905, 0.043, 0.003, 0.006, 0.005, 0-12J, MDT2260884, 387-90, 0.032, 0.004, FA1326, 9YEARS and 5 more |
| Date | Nov 2, 2023 |
| Regulator page | bfarm.de |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1