Drug recall
Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable…
FDA recall event 84944 · Class II · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Key facts
| Event ID | 84944 |
|---|---|
| Recall numbers | Z-1524-2020, Z-1525-2020 |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| Product type | Devices |
| Products | Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT., Medtronic CareLink Encore 29901 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission of sensitive information. |
| Initiation date | Jan 30, 2020 |
| Report date | Mar 25, 2020 |
| City | Mounds View |
| State | MN |
| Country | United States |
| FEI number | 2182208 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: