The Recall of Guidant Defibrillators and Pacemakers
April 12, 2007 Update:
On April 12 th 2007, Boston Scientific/Guidant and the FDA recalled a subset of devices within the CONTAK RENEWAL 3 & 4, VITALITY and VITALITY 2 families. This new recall includes about 73,000 implantable cardiac resynchronization therapy defibrillators and cardiac defibrillators due to faulty capacitors. While this recall is similar to the recall of May 2006, this time the failure modes and patient outcomes differ. The capacitors have been causing accelerated battery depletion and reducing the time between the elective replacement indicators and end of life to less than three months.
Models affected by the recalls:Class I Pacemaker Recalls:
- PULSAR® MAX Models 1170, 1171, 1270
- PULSAR Models 0470, 0870, 0972, 1172, 1272
- DISCOVERY® Models 1174, 1175, 1273, 1274, 1275
- MERIDIAN® Models 0476, 0976, 1176, 1276
- DISCOVERYII Models 0481, 0981, 1184, 1186, 1187, 1283, 1284, 1285, 1286
- PULSAR MAX II Models 1180, 1181, 1280
- CONTAK TR® Model 1241
- VIRTUS PLUS® II* Models 1380, 1480
- INTELIS II Models 1483, 1484, 1485, 1384, 1385, 1349, 1499
- CONTAK RENEWAL®2 Model H155
- CONTAK RENEWAL® Model H135
- VENTAK PRIZM® 2 DR, Model 1861
- VENTAK PRIZM AVT
- VITALITY AVT
- RENEWAL AVT
- CONTAK RENEWAL 3 & 4
- RENEWAL 3 & 4AVT
- RENEWAL RF
Pacemakers are small devices that are placed in your chest by a surgical procedure, that help control your heart beat. Pacemakers keep your heart from beating too slowly, to rapidly or too irregularly. Most pacemakers can be checked and reprogrammed at the doctor's office.
Implantable defibrillators are also placed in your chest during surgery. They keep your heart from stopping by detecting problem heart rhythms and delivering a shock to the heart muscle. Most implantable defibrillators also function as pacemakers.
The Problem with Guidant Defibrillators and Pacemakers
In March 2005, a young man died because his pacemaker failed. In April, the company acknowledged that they knew of similar incidents with Guidant defibrillators and pacemakers, and in July 2005, they issued a voluntary recall for several of their pacemakers. At that time, they said that none of the models being recalled had been sold or implanted for over four years.
Later in July, and again in October and December of 2005, Guidant and the FDA issued updates, adding more products to the recall. Some of these products had been manufactured within the past year and were continuing to be sold.
In the end, over 160,000 Guidant defibrillators and pacemakers were recalled. At least seven people died because of the product defect. The worst part of the tragedy is that Guidant has since admitted that they knew problems existed three years before they recalled any devices.
The Defect in Guidant Defibrillators and Pacemakers
There were two defects. The Guidant defibrillators and pacemakers that received a Class II recall had an insulation defect that could cause a switch to trip, shutting the device off. It could be fixed by reprogramming the device in the doctor's office.
The rest of the Guidant defibrillators and pacemakers had a leaky seal that allowed moisture to get inside the pacemaker or defibrillator and short it out.
Signs and Symptoms
When Guidant defibrillators and pacemakers fail, the patient may experience shortness of breath, excessive fatigue, confusion or dizziness. She may notice that her pulse is too fast or too slow, or may feel "heart flutters." She may even lose consciousness and die.
Some Guidant defibrillators and pacemakers emit a beeping sound when they are failing.
People with Guidant defibrillators and pacemakers who have any of those symptoms or who hear (or others around them hear) a beeping sound should immediately seek medical help.
People who decide to have Guidant defibrillators and pacemakers replaced receive a new on at no cost from Guidant. Guidant will also, in some cases, provide some monetary compensation for expenses not covered by your health care insurance or Medicare.
This does not completely cover the cost of having Guidant defibrillators and pacemakers replaced, and it doesn't cover any of your other costs or compensate you in any other way. Those who have Guidant defibrillators and pacemakers implanted might consider consulting our personal injury or medical malpractice attorneys to help them seek adequate compensation. Let us help you today.