Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO

Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.

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 required, contact Technical Services to assist with the upgrade. o If the device presents in MRI or EVVI mode, reprogram the device to the desired mode and settings. 3. Please return a completed Acknowledgement Form and maintain a record of this notice . along with a copy of the completed Acknowledgement Form to ensure effectiveness of the communication. 4. Adverse reactions or quality problems experienced with the use of this product should be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. - Complete and submit the report Online: www.fda.gov/medwatch/report.htm - Regular Mail or Fax: Download form https://www.fda.gov/safety/medical-product-safety-information/medwatchforms-fda-safety-reporting or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178