Medtronic CareLink” Monitor
Medical device recall Z-1605-2016. Published in FDA’s Enforcement Report on May 11, 2016.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on May 11, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 5038 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are 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.
5038, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Serial Number 2020B LPH003245P 2020B LPH004235P 2020B LPH004270P 2020B LPH004448P 2020B LPH004578P 2020B LPH006282P 2020B LPH006598P 2020B LPH006892P 2490C IJX010143A 2490C IJX010218A 2490C IJX010291A 2490C IJX010304A 2490C…
Every code shown here, 1,998 characters
Model Serial Number 2020B LPH003245P 2020B LPH004235P 2020B LPH004270P 2020B LPH004448P 2020B LPH004578P 2020B LPH006282P 2020B LPH006598P 2020B LPH006892P 2490C IJX010143A 2490C IJX010218A 2490C IJX010291A 2490C IJX010304A 2490C IJX010320A 2490C IJX010414A 2490C IJX010416A 2490C IJX010441A 2490C IJX010474A 2490C IJX010489A 2490C IJX010501A 2490C IJX010521A 2490C IJX014234A 2490C IJX014380A 2490C IJX014382A 2490C IJX014387A 2490C IJX014436A 2490C IJX014473A 2490C IJX014502A 2490C IJX014591A 2490C IJX019468A 2490C IJX019469A 2490C IJX019550A 2490C IJX019568A 2490C IJX019647A 2490C IJX019681A 2490C IJX019716A 2490C IJX019729A 2490C IJX019731A 2490C IJX019752A 2490C IJX019753A 2490C IJX019756A 2490C IJX019782A 2490C IJX019824A 2490C IJX019845A 2490C IJX019905A 2490C IJX019933A 2490C IJX019944A 2490C IJX019947A 2490C IJX020167A 2490C IJX020175A 2490C IJX020197A 2490C IJX020240A 2490C IJX020247A 2490C IJX020371A 2490C IJX020403A 2490C IJX020409A 2490C IJX020419A 2490C IJX020450A 2490C IJX020467A 2490C IJX020566A 2490C IJX020620A 2490C IJX020715A 2490C IJX020774A 2490C IJX020781A 2490C IJX020803A 2490C IJX020806A 2490C IJX020811A 2490C IJX020846A 2490C IJX020861A 2490C IJX020862A 2490C IJX020914A 2490C IJX020920A 2490C IJX020987A 2490C IJX020988A 2490C IJX021117A 2490C IJX021158A 2490C IJX021172A 2490C IJX021239A 2490C IJX021335A 2490C IJX021355A 2490C IJX021422A 2490C IJX021477A 2490C IJX021512A 2490C IJX021545A 2490C IJX021551A 2490C IJX021582A 2490C IJX021599A 2490C IJX021610A 2490C IJX021621A 2490C IJX021631A 2490C IJX021646A 2490C IJX021684A 2490C IJX021777A 2490C IJX021783A 2490C IJX021804A 2490C IJX021809A 2490C IJX025346A 2490C IJX028261A 2490C IJX028274A 2490C IJX028283A 2490C IJX028314A 2490C IJX028322A 2490C IJX028333A 2490C IJX028351A 2490C IJX028406A 2490C IJX028432A 2490C IJX028434A 2490C IJX028495A 2490C IJX028503A 2490C IJX028515A 2490C IJX028537A 2490C IJX028543A 2490C IJX028550A 2490C IJX028551A 2490C IJX028568A 2490C IJX028600A 2490C IJX028602A 2490C…
FDA’s list runs to 85,666 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
AUSTRIA, AUSTRALIA, BELGIUM, SWITZERLAND, GERMANY, DENMARK, FRANCE, GREAT BRITAIN, HUNGARY, JAPAN, NETHERLANDS, NEW ZEALAND, POLAND, PORTUGAL, SWEDEN.
These words name no state.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 31, 2016.
- FDA classified it on May 4, 2016.
- FDA’s Enforcement Report published it on May 11, 2016.
- FDA terminated it on Sep 25, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic Inc., Cardiac Rhythm and Heart Failure, of Mounds View, MN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 85,666 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.