Abbott Medical - 111016731
Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Cardia Resynchronization Therapy Defibrillator *CRT-D) devices that were manufactured prior to April 2022 as a result of crystal component issue within the Bluetooth Low Energy (BLE) circuit. This results in the device entering an inductive telemetry only mode with loss of Bluetooth communication. In some instances, thought BLE communication is unavailable, the circuit may remain in a state which draws excessive power affecting battery longevity.
Abbott Medical - 111016731
This product is a medical device that may pose a risk of injury or harm if used improperly or without proper training.
All
Check for proper labeling, instructions for use, and certification from Abbott Medical.
Ensure the device is used according to the manufacturer's instructions.
Verify that the device has been certified by Abbott Medical.
Consult a healthcare professional before using the device.
This product is intended for medical use and should be used under the supervision of a healthcare professional.
Using this product without proper training may lead to incorrect usage, which could result in injury or harm.
Check the product's packaging for certification labels from Abbott Medical and ensure it meets all regulatory standards.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-2614-2023 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-2614-2023 from Abbott. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
