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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only
Recalled July 21, 2021 · FDA recall Z-2076-2021 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Hazard
Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset. · FDA Class II
Units
21,685
Sold at
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.
Description
Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset.
Product
Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only
Manufacturer(s)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →