International safety notice
Desfibriladores automáticos implantables (DAI) y dispositivos de terapia de resincronización cardiaca con desfibrilador (TRC-D): DAI y TRC-D: Cobalt XT; Cobalt y Crome. TRC-D: Claria MRI; Amplia MRI; Compia MRI; Viva y Brava. DAI Visia AF; Visia AF MRI; Evera; Evera MRI; Primo MRI y Mirro MRI
Spain / AEMPS · ESP · Nov 20, 2023
Key facts
| Title | Desfibriladores automáticos implantables (DAI) y dispositivos de terapia de resincronización cardiaca con desfibrilador (TRC-D): DAI y TRC-D: Cobalt XT; Cobalt y Crome. TRC-D: Claria MRI; Amplia MRI; Compia MRI; Viva y Brava. DAI Visia AF; Visia AF MRI; Evera; Evera MRI; Primo MRI y Mirro MRI |
|---|---|
| Regulator | Spain / AEMPS |
| Country | ESP |
| Brand | Desfibriladores automáticos implantables (DAI) y dispositivos de terapia de resincronización cardiaca con desfibrilador (TRC-D): DAI y TRC-D: Cobalt XT; Cobalt y Crome. TRC-D: Claria MRI; Amplia MRI; Compia MRI; Viva y Brava. DAI Visia AF; Visia AF MRI; Evera; Evera MRI; Primo MRI y Mirro MRI |
| Manufacturer | Medtronic Inc, EEUU. |
| Models | 91.822.52.89, FA1326, 2023-239.LA, 28050, 2023-239, US-MF-000019977, 28022, 2023-534, 93509 |
| Event type | Safety Notice |
| Date | Nov 20, 2023 |
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