Guidant Recall Overview

Guidant Corporation of St. Paul, Minnesota has long been a member of the medical advancement community. Guidant has put many products on the market, and most, if not all of them came with a high degree of promise. Specifically, Guidant has released products that are or are related to defibrillators and pacemakers.

However, the company has come under significant scrutiny in recent years for several reasons, most prominently because of several recalls that were initiated. Below is a look at each of them related to the product types listed above.

List of Recalled Pacemakers

On July 18, 2005, a Class I recall was initiated for the following products manufactured between November 25, 1997 and October 26, 2000:

• PULSAR® MAX Models 1170, 1171, 1270
• PULSAR Models 0470, 0870, 0970, 0972, 1172, 1272
• DISCOVERY® Models 1174, 1175, 1273, 1274, 1275
• MERIDIAN® Models 0476, 0976, 1176, 1276
• PULSAR MAX II Models 1180, 1181, 1280
• DISCOVERY II Models 0481, 0981, 1184, 1186, 1187, 1283, 1284, 1285, 1286
• CONTAK TR® Model 1241
• VIRTUS PLUS® II* Models 1380, 1480
• INTELIS II Models 1483, 1484, 1485, 1384, 1385, 1349, 1499

The reason for this recall was that these devices contained a seal, and this seal was showing a propensity to leak. As a result, moisture damaged the electronic circuits within the product. The FDA’s Web site states that, “The problems may occur without warning and can lead to loss of consciousness, and possibly heart failure and death.”

Defibrillators Recall List.

On June 17, 2005, the FDA issued a press release stating that the following devices were being recalled:

• 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

The reason was that these devices, which are surgically implanted in patients with an irregular heartbeat to help regulate it, showed the potential to develop an internal short circuit, thereby failing to deliver the electric shock needed to regulate the heart.

Additional Allegations Regarding Guidant Defibrillators

Exacerbating the problem was the subsequent revelation that Guidant had allegedly waited up to three years from the time that this defect was discovered before reporting it. Further assertions allege that this revelation only took place when Guidant learned that the New York Times was about to publish a story in regards to these defibrillators.

If you were implanted with any of the devices listed above, you need to seek medical attention immediately. After you’ve received medical help, contact an experienced trial attorney immediately for a full analysis of your situation.