Severity
Moderate
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.
Reported: May 11, 2016 Initiated: March 31, 2016 #Z-1605-2016 5038 units
Medtronic Inc., Cardiac Rhythm and Heart Failure issued this FDA Devices recall on May 11, 2016. Classified as Moderate severity (Class II). Approximately 5038 units are affected. The recall was issued because: A recent firmware update developed by Medtronic for the 2490C CareLink Monitors and 2020B CareLink Express Monitors inc…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-1605-2016) was formally reported on May 11, 2016, with the manufacturer initiating the action on March 31, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Medtronic Inc., Cardiac Rhythm and Heart Failure is listed as the recalling firm, operating out of Mounds View, MN. Federal records indicate 5038 units are affected.
The documented reason for this recall is: 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 C… Distribution data in the federal record shows the product reached: AUSTRIA, AUSTRALIA, BELGIUM, SWITZERLAND, GERMANY, DENMARK, FRANCE, GREAT BRITAIN, HUNGARY, JAPAN, NETHERLANDS, NEW ZEALAND, POLAND, PORTUGAL, SWEDEN.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 10 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
5038
Related Recalls
6
6 from same agency
Recall Progress (industry avg ~60%) 60.0%
Product Description
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
Details
- Recalling Firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure
- Units Affected
- 5038
- Distribution
- AUSTRIA, AUSTRALIA, BELGIUM, SWITZERLAND, GERMANY, DENMARK, FRANCE, GREAT BRITAIN, HUNGARY, JAPAN, NETHERLANDS, NEW ZEALAND, POLAND, PORTUGAL, SWEDEN.
- Location
- Mounds View, MN
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1605-2016 |
| Date reported | May 11, 2016 |
| Date initiated | March 31, 2016 |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure |
| Units affected | 5038 |
| Distribution | AUSTRIA, AUSTRALIA, BELGIUM, SWITZERLAND, GERMANY, DENMARK, FRANCE, GREAT BRITAIN, HUNGARY, JAPAN, NETHERLANDS, NEW ZEALAND, POLAND, PORTUGAL, SWEDEN. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure. Units affected: 5038.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 11, 2016. Severity: Moderate. Recall number: Z-1605-2016.
Where was the recalled product distributed? ▼
Distribution: AUSTRIA, AUSTRALIA, BELGIUM, SWITZERLAND, GERMANY, DENMARK, FRANCE, GREAT BRITAIN, HUNGARY, JAPAN, NETHERLANDS, NEW ZEALAND, POLAND, PORTUGAL, SWEDEN..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1605-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).