Recall Z-2076-2021 ยท MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only
| Date | Jul 14, 2021 (initiated May 14, 2021) |
| Status | Open, Classified |
| Reason | Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset. |
| Root cause | Software design |
| Action | On June 1 2021 Medtronic sent a letter notifying the consignees the following: -LINQ II insertable cardiac monitors (ICM) that undergo a partial electrical reset appear to be programmed ON, but are no longer able to detect and report Brady, Pause, and PVC events to clinicians. Medtronic estimates that 0.21% of LINQ II ICMs have experienced a partial electrical reset resulting in the inability to detect Brady, Pause, and PVC events. -A correction for currently implanted LINQ II ICMs is not available. -We are requesting that hospitals quarantine all LINQ II ICMs on hospital shelves. Physicians |
| Quantity | 21,685 |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200795 | LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool K Medtronic, Inc., Jul 3, 2020 |