US Senator opens Guidant Investigation
December 8, 2005 08:51

As a result of a series of recalls, which seem never to end, Senator Charles Grassley of Iowa amd chairman of the Senate Finance Committee has begun to question whether the company violated a 2003 agreement requiring them to alert the FDA of product problems.

Others in Congrss also question Guidant's actions. Congressman Edward J. Markey of Massachussetts has asked whether, "Companies should not be allowed to hid problems until the FDA comes to seek the out."

Guidant has clearly acted badly and many lawsuits have now been filed. Hopefully these investigation, along with the lawsuits, will bring to light the magnitude of problems with these devices and the problems with relying on the manufcaturers to come forward voluntarily.

Another 70,000 units have been added to those identified for reall. It seems to never end. Guidant has been under fire since they delayed issuing information about known defects and in fact actually continued to sell units with known defects.

"Boston Scientific Corp. said on Thursday it is voluntarily recalling all of its Flextome Cutting Balloon systems, products used to help cut through fatty deposits in heart arteries, because of a malfunction that could require additional surgery. The company said it was recalling about 40,000 devices and said the move does not affect patients who have received treatment with the recalled devices." Reuters, 12/8/05

Medtronic is informing physicians of a potential risk in a subset of pacemakers. Patients with Sigma pacemakers who experience a return of symptoms should seek medical attention.

The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

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Guidant VENTAK PRIZM 2 DR and CONTAK RENEWAL Implantable Cardioverter Defibrillators

Audience: Cardiologists and other healthcare professionals

[UPDATE December 29, 2005] FDA issued an update to the July and October, 2005, Preliminary Public Health Notification. The updated PPHN provides numbers of deaths and serious injuries for the three devices as of December 12, 2005. FDA's recommendations have not changed.

[Posted 07/18/2005] FDA issued a Preliminary Public Health Notification and advice for patients for Guidant VENTAK PRIZM 2 DR and CONTAK RENEWAL Implantable Cardioverter Defibrillators to provide clinicians with current information and guidance concerning malfunctions occurring with these devices, which were the subjects of a Class I recall announced by FDA on July 1, 2005. The malfunction that is the subject of the recall causes damage to the device’s circuitry, potentially resulting in the inability to deliver the required shock during episodes of arrhythmia. This malfunction could lead to a serious, life-threatening event. Importantly, the device does not give any sign of impending failure, and there is no test that predicts whether any particular device will fail. The affected devices are:

VENTAK PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002

CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004

CONTAK RENEWAL 2, Model H155, manufactured on or before August 26, 2004.