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| Chaffin Luhana LLP

On February 13, 2013, the FDA notified healthcare professionals of another product recall issued by St. Jude Medical, manufacturer of the previously recalled Eon Mini implantable pulse generator (IPG). This time, the company implemented a Class I recall of the Amplatzer TorqVue FX Delivery System, which is used during the surgical repair of atrial heart defects.

According to the FDA, in a small number of cases, the distal end of the core wire of the TorqVue FX Delivery System could potentially fracture, which may cause adverse health consequences, including death.

Amplatzer May Cause Injury and Death

Though the FDA just recently notified doctors of the recall, St. Jude actually initiated it on January 18, 2013. The day before, they sent an Urgent Medical Device Recall Notice to their customers, advising them to stop using the device and to remove it from their inventories.

The Amplatzer is used to assist the attachment, loading, delivery, and deployment of Amplatzer Occluder devices—which doctors use to close openings between the two upper chambers of the heart. The recall affects products manufactured between August 24, 2012 and September 24, 2012, and distributed between October 1, 2012 and January 9, 2013.

The FDA states that St. Jude Medical plans to "have their sales representatives perform site visits to assist with recall activities, including completion of the product reconciliation form and return of any unused product." The agency adds that Class I recalls are the most serious type of recalls, and involve situations in which there is a reasonable probability of the product causing serious health consequences or death.

Eon Mini Recall Update

This recall comes on the heels of another recall update issued in July 2012, in which St. Jude Medical updated healthcare professionals on customer complaints related to the Eon Mini IPG. A neuromodulation device, the Eon transmits electrical impulses to help ease chronic back pain.

After a recall of certain Eon Mini models in May 2011, the company noted in the July 2012 update that 214 patients had reported that the device stopped working, causing a return of symptoms. An earlier December 2011 update also noted that over 200 patients had complained of warmth or heating of the implant during charging, with three patients reporting 1st– and 2nd-degree burns.

One patient has already filed an Eon Mini lawsuit, complaining that the device stopped working after only six months, when the St. Jude Medical website advertises it as lasting for up to 10 years.

Company Facing FDA Warnings

These two products aren’t the only St. Jude Medical products raising concerns. On January 10, 2013, the FDA issued a warning letter about the Durata and Riata St. Optim high voltage implantable cardiac leads, which connect an implanted defibrillator to a patient’s heart. During an inspection of the company’s Sylmar, California operations, the FDA found that the facilities were not in conformance with standard good manufacturing practices, and also stated that the devices themselves were adulterated.

"Your firm should take prompt action to correct the violations addressed in this letter," wrote Mr. Blake Bevill, Director, Compliance Branch for the FDA.

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