St. Jude Pacemaker/Defibrillator Recall Overview

St. Jude has been one of the leading distributors of medical devices for years, and the company is based in Sylmar, California. The company has marketed pacemakers/defibrillators for years, but recent incidents have arisen that have brought the products that follow under scrutiny.

Pulse Generators (a.k.a. Pacemakers)

The reason for these recalls all centered on the “memory recoil ring” that was part of the original products. Statistics began to show that this ring can break under the stress of placement of the large-sized products in the intra-abdominal (inside the belly area) space, according to the information put out by the FDA.

This breaking, according to the FDA's Web site, lead to bowel perforations (rupture) and/or chronic (recurring) intestinal fistulae (abnormal connections or passageways between the intestines and other organs). This condition can lead to abnormal and prolonged abdominal pain, fever, tenderness in the implanted area and a host of other symptoms.

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Pulse Generators II

On July 21, 2003, the company initiated another recall of pacemaker products, and the following model numbers were affected:

Integrity ADx DR Model 5360 & 5366
Identity ADxDR model 5286, 5380, 5386 &5480
Verity ADx DR 5256, 5356 & 5456

The reason for this recall was the same as above – an anomaly in the pacemaker code.

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Implantable Cardioverter-Defibrillator

On March 10, 2005, St. Jude initiated a recall of defibrillators, and the following models were recalled:

Atlas+ Models V-193, V-193C and V-243
Epic+ Models V-196, V-236 and V-239
Epic Models V-197 and V-233
Atlas Model V-242
Epic HF Models V-337 and V-338
Epic+HF Models V-339 and V-350
Atlas+ HF Models V-340, V-341 and V-343

These models were recalled because the sensitivity of a magnetic switch was not being set correctly, which led to the delivery of an unneeded shock to the heart during surgery.

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Implantable Cardioverter Defibrillators II

On June 17, 2005, St. Jude once again recalled a series of defibrillators, and the following models were specified:

Epic DR/HF (V-233/V-337/V-338)
Epic Plus DR/VR/HF (V-236/V-239/V-196/V-239T/V-196T/V-350)
Atlas DR (V242)
Atlas Plus DR/VR/HF (V-243/V-193C/V-340/V-341/V-343)

These models were recalled because, according to the FDA, “Two corrections to firmware due to Skipped-Charge Shock and Sensor Noise Anomaly are being made with one noninvasive upgrade.”

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Overall Impact

The problems with these products were all potentially serious.  Any problems with technology that helps regulate a patient’s heart can lead to serious injuries, the necessity for replacement surgery if a part needs to be removed, and death if the problem is not corrected in a timely manner.

Overall, if any of these products have been used to help you, contact your doctor and then an experienced trial attorney immediately, as you have needs and rights that need to be protected.

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