Recall Z-1695-2024 ยท PNJ Leadless Pacemaker
Abbott Medical
Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO
| Date | Apr 29, 2024 (initiated Feb 5, 2024) |
| Status | Open, Classified |
| Reason | Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change. |
| Root cause | Device Design |
| Action | On April 3, 2024, Abbott issued a "Urgent Medical Device Correction" to affected consignees via certified mail, email or hand-delivery. Abbott asked consignees to take the following actions: 1. Prophylactic device replacement is NOT recommended. o All currently manufactured LSP112V devices utilize the upgraded firmware. o Following the firmware upgrade, the implanted device will be equivalent to newly manufactured LSP112V devices. 2. As part of follow-up, suggested within 3 months, upgrade the LSP112V firmware. o For most devices, the upgrade will execute automatically when interrogated. If r |
| Quantity | 10,610 units |
| Distribution | US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV. OUS: Pending |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.