Medtronic CareLink" Monitor — Class II medical device recall Z-1605-2016
Terminated recall by Medtronic Inc., Cardiac Rhythm and Heart Failure, reported 2016-05-11. A recent firmware update developed by Medtronic for the 2490C CareLink Monitors and 2020B CareLink Express Mon
| Recall number | Z-1605-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure, Mounds View, MN, United States |
| Recall initiated | 2016-03-31 |
| Classified | 2016-05-04 |
| Reported by FDA | 2016-05-11 |
| Terminated | 2017-09-25 |
| Countries outside the US | AT, AU, BE, CH, DE, DK, FR, GB, HU, JP, NL, NZ, PL, PT, SE |
| Quantity | 5,038 |
| Reason classes | software |
| Serial numbers | 2020B, 2490C, IJX010143A, IJX010218A, IJX010291A, IJX010304A, IJX010320A, IJX010414A, IJX010416A, IJX010441A, IJX010474A, IJX010489A, IJX010501A, IJX010521A, IJX014234A, IJX014380A, IJX014382A, IJX014387A, IJX014436A, IJX014473A, IJX014502A, IJX014591A, IJX019468A, IJX019469A, IJX019550A and 475 more |
Product
Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor (2020B) Product Usage: The 2490C CareLink Home Monitors and 2020B CareLink Express Monitors are remote monitoring systems that interrogate implanted devices and transmit the data to Medtronic s CareLink Network for viewing by the physician. The data is transmitted either through an analog telephone line, a cellular connection or an internet connection.
Reason for recall
A recent firmware update developed by Medtronic for the 2490C CareLink Monitors and 2020B CareLink Express Monitors included incorrect data on the country analog modem dial-up configuration table used to dial into the CareLink Network. This incorrect data resulted in the removal of the 0 prefix necessary for select countries as well as an incorrect alignment of phone numbers for other select cou
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.