FDA Orders Recall Of Defective Boston Scientific Implant Device
Medical devices are one of the most important products that can save an individual’s life if made and used correctly.
However, the authorities ordered a medical device manufacturing company to recall one of their products in December last year after reports of serious harm and fatality caused by their product that was supposed to do the opposite.
According to reports, Boston Scientific has been ordered by the United States Food and Drug Administration (FDA) to recall its EMBLEM S-ICD in early December before last year came to a conclusion.
Per the authorities’ recall announcement details, the EMBLEM S-ICD may face issues caused by its built-in subcutaneous electrode.
The subcutaneous electrode is the part of the device that is used to detect irregularities in a patient’s heartbeat.
Medical devices like Boston Scientific’s EMBLEM S-ICD is an implantable cardioverter defibrillator (ICD).
It is used to treat a cardiovascular medical ailment known as arrhythmia.
Unlike other implantable cardioverter defibrillators in the market that use implants directly attached to a person’s heart and/or surrounding blood vessels, Boston Scientific’s EMBLEM S-ICD uses an implant that is placed outside the individual’s heart.
However, this makes it possible to break off and become unusable, ergo failing in delivering much-needed life-saving treatments to a patient.
Due to this, over 19,000 Boston Scientific EMBLEM S-ICD were recalled off the market to lower the risks of a patient experiencing device failure when using them.
For those who have already have the product implanted in their bodies, the authorities have assured that there are forms of relief available to control the risks of device failure.
Medical professionals around the country were asked to do a check-up on patients who have the EMBLEM S-ICD for defects on their medical device.
This can be done through Boston Scientific’s Latitude screening technology. A series of in-office follow-ups are recommended every three months in order to monitor the device.
In the worst-case scenario, if a patient’s EMBLEM S-ICD is defective, surgery may be required to have the defective medical device.
About Boston Scientific
Boston Scientific Corporation or simply referred to as Boston Scientific, in this feature, is a company specializing in making an array of medical devices geared towards interventional medical use.
Founded in 1979, the company makes different implants used by medical professionals worldwide for their patients’ care.
The company has its headquarters in Massachusetts and employs about 36,000 individuals in its workforce.
Editor’s Note on Defective Boston Scientific ICD Recall:
This feature is published to inform you of the latest recall order by the FDA involving Boston Scientific’s EMBLEM S-ICD implant.
This comes after cases were reported of people experiencing serious injury after their devices ended up malfunctioning.
What are your thoughts on this piece? Please send us a message by clicking the ‘Contact Us’ button below. We’d love to hear back from you!
Similar Recall: FDA Orders A Recall For Hillrom Multirall Patient Lifts.