Z-2076-2021 Class II Ongoing
FDA device recall Z-2076-2021 was initiated by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) on May 14, 2021 and is designated Class II. Reason for recall: Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset. The recall status is ongoing. Affected quantity: 21,685.
Recall Details
- Product Type
- Devices
- Report Date
- July 21, 2021
- Initiation Date
- May 14, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21,685
Product Description
Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only
Reason for Recall
Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset.
Distribution Pattern
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.
Code Information
Model Number: LNQ22