Abbott Medical is a leading provider of medical devices, diagnostic equipment, and healthcare solutions. We offer innovative products for healthcare professionals and patients worldwide.
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 is a leading provider of medical devices, diagnostic equipment, and healthcare solutions. They focus on innovation and quality to meet the needs of healthcare professionals and patients globally.
Low risk of harm as the brand is well-established and provides medical devices and equipment that are generally safe and effective.
Healthcare professionals and patients
Check for proper certifications and compliance with medical standards (e.g., FDA, CE marking) when purchasing medical devices from Abbott Medical.
Verify that the product has the necessary certifications (e.g., FDA, CE marking) before use.
Ensure the product is intended for the specific medical application and not used for purposes outside its intended use.
Follow the manufacturer's instructions for use and maintenance to ensure safe operation.
Yes, Abbott Medical is a well-established and reputable brand in the medical device industry, known for producing high-quality and safe medical equipment.
Abbott Medical products typically require certifications such as FDA approval in the United States or CE marking in Europe. Always check the product documentation for specific certification requirements.
Ensure the product has the necessary certifications, use it only as intended, and follow the manufacturer's instructions for safe operation and maintenance.
We’ve drafted a message you can send Abbott Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2615-2023 — Abbott Medical Abbott Medical Hello, I own a Abbott Medical that is covered by recall Z-2615-2023 from Abbott Medical. 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.
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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.
