International safety notice
Cobalt™ XT/Cobalt™/Crome™ ICDs and 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
Ireland / HPRA · IRL · Jun 2, 2023
Key facts
| Title | Cobalt™ XT/Cobalt™/Crome™ ICDs and 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 |
|---|---|
| Regulator | Ireland / HPRA |
| Country | IRL |
| Brand | Cobalt™ XT/Cobalt™/Crome™ ICDs and 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 | US-MF-000019977, MDT2260884-CRHF, 0.002, MDT2260884, 0.032, FA1326, 0.006, ~0-12J, 0.003, 0.001, 387-90, 1895-1905 and 5 more |
| Event type | Safety Notice |
| Date | Jun 2, 2023 |
| Regulator page | hpra.ie |
At a glance
- No Recall
- Yes 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