Device recalls
Recall records from FDA, newest initiation date first.
Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.
Data as of , the FDA export date. FDA medical device recall database
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-1821-2023 | Class I | ICD COBALT VR MRI DF4, Model Number DVPB3D4; Implantable Cardioverter Defibrillators | Medtronic, Inc. | LWS | |
| Z-1820-2023 | Class I | ICD COBALT VR MRI IS1 DF1, Model Number DVPB3D1; Implantable Cardioverter Defibrillators | Medtronic, Inc. | LWS | |
| Z-1819-2023 | Class I | ICD COBALT XT VR MRI DF4, Model Number DVPA2D4; Implantable Cardioverter Defibrillators | Medtronic, Inc. | LWS | |
| Z-1818-2023 | Class I | ICD COBALT XT VR MRI IS1 DF1, Model Number DVPA2D1; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1817-2023 | Class I | ICD-VR DVME3D4 MIRRO MRI, Model Number DVME3D4; Implantable Cardioverter Defibrillators | Medtronic, Inc. | LWS | |
| Z-1816-2023 | Class I | ICD-VR DVME3D1 MIRRO MRI, Model Number DVME3D1; Implantable Cardioverter Defibrillators | Medtronic, Inc. | LWS | |
| Z-1815-2023 | Class I | ICD-VR DVMD3D4 PRIMO MRI, Model Number DVMD3D4; Implantable Cardioverter Defibrillators | Medtronic, Inc. | LWS | |
| Z-1814-2023 | Class I | ICD-VR DVMD3D1 PRIMO MRI, Model Number DVMD3D1; Implantable Cardioverter Defibrillators | Medtronic, Inc. | LWS | |
| Z-1813-2023 | Class I | ICD-VR DVMC3D4 EVERA MRI S DF4 GLOB, Model Number DVMC3D4; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1812-2023 | Class I | ICD-VR DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1811-2023 | Class I | ICD-VR DVMB2D4 EVERA MRI XT DF4 INTL, Model Number DVMB2D4; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1810-2023 | Class I | ICD-VR DVMB2D1 EVERA MRI XT OUS DF1, Model Number DVMB2D1; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1809-2023 | Class I | ICD-VR DVMB1D4 EVERA MRI XT DF4 US, Model Number DVMB1D4; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1808-2023 | Class I | ICD-VR VISIA MRI AF S US/OUS DF4, Model Number DVFC3D4; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1807-2023 | Class I | ICD-VR DVFC3D1 VISIA AF MRI S OUS/US DF1, Model Number DVFC3D1; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1806-2023 | Class I | ICD-VR VISIA MRI AF XT OUS DF4, Model Number DVFB2D4; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1805-2023 | Class I | ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1804-2023 | Class I | ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1803-2023 | Class I | ICD-VR DVFB1D1 VISIA AF MRI US DF1, Model Number DVFB1D1; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1802-2023 | Class I | ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1801-2023 | Class I | ICD-VR DVEX2E4 EV ICD OUS EV4, Model Number DVEX2E4; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1800-2023 | Class I | ICD-VR DVBC3D4 EVERA S DF4 GLOB, Model Number DVBC3D4; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1799-2023 | Class I | ICD-VR DVBC3D1 EVERA S IS1/DF1 GLOB, Model Number DVBC3D1; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1798-2023 | Class I | ICD-VR DVBB2D4 EVERA XT DF4 INTL, Model Number DVBB2D4; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1797-2023 | Class I | ICD-VR DVBB2D1 EVERA XT IS1/DF1 INTL, Model Number DVBB2D1; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1796-2023 | Class I | ICD-VR DVBB1D4 EVERA XT DF4 US, Model Number DVBB1D4; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1795-2023 | Class I | ICD-VR DVBB1D1 EVERA XT IS1/DF1 US, Model Number DVBB1D1; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1794-2023 | Class I | ICD-VR VISIA AF S US/OUS DF4, Model Number DVAC3D4; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1793-2023 | Class I | ICD-VR VISIA AF S US/OUS IS1/DF1, Model Number DVAC3D1; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1792-2023 | Class I | ICD-VR VISIA AF XT OUS DF4, Model Number DDVAB2D4; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1791-2023 | Class I | ICD-VR VISIA AF XT OUS IS1/DF1, Model Number DVAB2D1; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1790-2023 | Class I | ICD-VR DVAB1D4 VISIA AF US DF4, Model Number DVAB1D4; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1789-2023 | Class I | ICD-VR DVAB1D1 VISIA AF US IS1/DF1, Model Number DVAB1D1; Implantable Cardioverter... | Medtronic, Inc. | LWS | |
| Z-1788-2023 | Class I | CRTD CROME HF QUAD MRI IS4 DF4, Model Number DTPC2QQ; Implantable Cardioverter... | Medtronic, Inc. | NIK | |
| Z-1787-2023 | Class I | CRTD CROME HF QUAD MRI IS4 DF1, Model Number DTPC2Q1; Implantable Cardioverter... | Medtronic, Inc. | NIK | |
| Z-1786-2023 | Class I | CRTD CROME HF MRI IS1 DF4, Model Number DTPC2D4; Implantable Cardioverter Defibrillators | Medtronic, Inc. | NIK | |
| Z-1785-2023 | Class I | CRTD CROME HF MRI IS1 DF1, Model Number DTPC2D1; Implantable Cardioverter Defibrillators | Medtronic, Inc. | NIK | |
| Z-1784-2023 | Class I | CRTD COBALT HF QUAD MRI IS4 DF4, Model Number DTPB2QQ ; Implantable Cardioverter... | Medtronic, Inc. | NIK | |
| Z-1783-2023 | Class I | CRTD COBALT HF QUAD MRI IS4 DF1, Model Number DTPB2Q1 ; Implantable Cardioverter... | Medtronic, Inc. | NIK | |
| Z-1782-2023 | Class I | CRTD COBALT HF MRI IS1 DF4, Model Number DTPB2D4; Implantable Cardioverter Defibrillators | Medtronic, Inc. | NIK | |
| Z-1781-2023 | Class I | CRTD COBALT HF MRI IS1 DF1, Model Number DTPB2D1; Implantable Cardioverter Defibrillators | Medtronic, Inc. | NIK | |
| Z-1780-2023 | Class I | ICD COBALT XT HF QUAD OUS, Model Number DTPA2QQG; Implantable Cardioverter Defibrillators | Medtronic, Inc. | NIK | |
| Z-1779-2023 | Class I | CRTD COBALT XT HF QUAD MRI IS4 DF4, Model Number DTPA2QQ; Implantable Cardioverter... | Medtronic, Inc. | NIK | |
| Z-1778-2023 | Class I | CRTD COBALT XT HF QUAD MRI IS4 DF1, Model Number DTPA2Q1; Implantable Cardioverter... | Medtronic, Inc. | NIK | |
| Z-1777-2023 | Class I | CRTD COBALT XT HF MRI IS1 DF4, Model Number DTPA2D4; Implantable Cardioverter... | Medtronic, Inc. | NIK | |
| Z-1776-2023 | Class I | CRTD DTPA2D1PX COBALT XT HF QUAD OUS, Model Number DTPA2D1PX; Implantable Cardioverter... | Medtronic, Inc. | NIK | |
| Z-1775-2023 | Class I | CRTD DTPA2D1G COBALT XT HF QUAD OUS, Model Number DTPA2D1G; Implantable Cardioverter... | Medtronic, Inc. | NIK | |
| Z-1774-2023 | Class I | CRTD COBALT XT HF MRI IS1 DF1, Model Number DTPA2D1; Implantable Cardioverter... | Medtronic, Inc. | NIK | |
| Z-1773-2023 | Class I | CRTD DTMC2QQ COMPIA MRI QUAD OUS DF4, Model Number DTMC2QQ; Implantable Cardioverter... | Medtronic, Inc. | NIK | |
| Z-1772-2023 | Class I | CRTD DTMC2D4 COMPIA MRI OUS DF4, Model Number DTMC2D4; Implantable Cardioverter... | Medtronic, Inc. | NIK |