Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO

FDA device recall Z-1695-2024 · posted 2024-04-29 · Open, Classified

Recall details

Recalling firm

Abbott Medical

Reason for recall

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

Action taken

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

Root cause

Device Design

Status

Open, Classified

Product code

PNJ

Quantity affected

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

Date initiated

2024-02-05

Date posted

2024-04-29

Location

Sylmar, CA