Drug recall
MEDTRONIC CARELINK 2090 programmer
FDA recall event 81949 · Class II · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Key facts
| Event ID | 81949 |
|---|---|
| Recall numbers | Z-0795-2019, Z-0796-2019 |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| Product type | Devices |
| Products | MEDTRONIC CARELINK 2090 programmer, MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The Medtronic CareLink Encore 29901 programmer system is comprised of prescription devices indicated for use in the interrogation and programming of implantable medical devices. Prior to use, refer to…, There is an error in how the programmer calculates and displays the remaining longevity value during a period of time (up to 2 years) prior to the device reaching its Recommended Replacement Time… |
| Initiation date | Jan 17, 2019 |
| Report date | Feb 13, 2019 |
| Termination date | Feb 2, 2021 |
| 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: