CLASS II ONGOING Device recall · Reported 21 Jul 2021 · FDA Enforcement Report
Medtronic LINQ II recalled by Medtronic Inc., Cardiac
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) is recalling Medtronic LINQ II, distributed nationwide in the US. The recall was initiated on 14 May 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2076-2021
- FDA event ID
- 88089
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 May 2021
- FDA classified
- 14 Jul 2021
- Reported
- 21 Jul 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Patient Monitors
Timeline
| 14 May 2021 | Recall initiated by company | |
| 14 Jul 2021 | Classified by FDA | +61 days |
| 21 Jul 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only
Where it was distributed
Worldwide distribution - US Nationwide in the states of AK, AL, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY. The countries of Australia, Austria, Canada, Denmark, Finland, Germany, Ireland, Italy, Netherlands, Netherlands Antilles, Sweden, Switzerland, and United Kingdom.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichigan
Questions about this recall
Is Medtronic LINQ II recalled?
Yes. Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalled Medtronic LINQ II on 14 May 2021. The recall is Class II and its status is Ongoing. Recall number Z-2076-2021.
Why was it recalled?
Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset.
Which lots are affected?
Model Number: LNQ22
Where was it sold?
Worldwide distribution - US Nationwide in the states of AK, AL, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY. The countries of Australia, Austria, Canada, Denmark, Finland, Germany, Ireland, Italy, Netherlands, Netherlands Antilles, Sweden, Switzerland, and United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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