Two deaths linked to St. Jude heart devices recall
St. Jude Medical announced a recall of some if its 400,000 implanted heart devices due to a risk of premature battery depletion, a condition that has recently been linked to two deaths in Europe.
In what manufacturers are calling a rare but serious problem, the devices are at risk of failing with very little warning to the patient.
The devices, which are St. Jude’s largest-selling product, monitor the heartbeat to prevent sudden cardiac arrest and heart beats that are too slow. All the devices, called ICDs and CRT-Ds, contain batteries that were manufactured before May 23, 2015, when the company added insulation to reduce the chance of an electrical short circuit.
The batteries were intended to last seven years or longer, or until their batteries depleted, however research has found that the device’s batteries tend to fail between three and four years after the implant.
The heart devices are designed to vibrate at regular intervals once power is diminished, a signal to patients that they should visit their doctors for replacements within 90 days.The company said one of the patients died after his vibration signal indicated low power, but a few days before his planned replacement.
An alert sent out by St. Jude said patients should contact their doctors if they think they have an affected device, but early replacement is probably not the best solution for most people, as the risks associated with replacing the devices likely outweigh the low risk of a patient experiencing problems with the device. If a replacement is necessary, the company may cover the cost of the device.
To find out if you have a device that may be affected by the recall, visit the St. Jude Medical website.
What The Carlson Law Firm Can Do To Help
If you have experienced a complication with a St. Jude Fortify™, Fortify Assura™, Quadra Assura™, Unify™, Unify Assura™ and Unify Quadra™ implantable cardiac defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) device, contact The Carlson Law Firm as soon as possible.
We have a team of dedicated product liability attorneys who have years of experience with medical device claims. At The Carlson Law Firm, however, you can expect to be treated with the utmost care, consideration, and compassion. We actually take the time to champion your cause, and most importantly, we guide you through the legal process.
Contact any one of our 11 offices today for free case evaluation. We serve clients nationwide.
- Written by Jill Fowler