Guidant Defibrillator
Guidant announced a voluntary recall on July 18, 2005. This consisted of a letter to physicians that described the problem and provided recommendations about how to minimize the risk of pacemaker failure. The FDA requested the recall after reviewing Guidant’s mishandling of issues concerning the heart devices. Guidant recently complied with the FDA request and voluntarily recalled the defective heart devices. Guidant previously said it did nothing wrong.
Some patients are very dependent on pacemakers to maintain an adequate heart rate. For them, failure of the device to provide pacing output can cause sudden faintness or loss of consciousness, possibly resulting in death. The leakage defect can also cause a sustained rapid heart rate, possible heart failure and even death.
While the failures can occur without warning, sometimes a leak-related malfunction can be detected by a physician before it causes serious problems. Guidant has provided information to physicians about ways to identify this kind of malfunction. However, the company advises it is not aware of any test that will show if a normally functioning pacemaker is likely to fail in the future.
Guidant claims that it discovered the short-circuiting defect in 2002 and changed the manufacturing of the devices that year to correct it. However, it is alleged that the manufacturer continued to sell the older, defective models without notifying doctors that improved ones were available. Defibrillators cost approximately $25,000 apiece. Guidant’s 2004 defibrillator sales totaled $1.8 billion. One can surmise that if the failure to report the problem to doctors installing the devices was for its own economic benefit, Guidant may have been more motivated by profits than patient safety.
The following models are affected by this recall.
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
VENTAK PRIZM 2 DR
CONTAK RENEWAL 1 and 2
* VIRTUS PLUS II and INTELIS II models available only outside the U.S.
The FDA has also issued a Class-2 warning (the probability of serious adverse health consequences is remote but possible) on the following models:
VENTAK PRIZM AVT
VITALITY AVT
RENEWAL AVT
RENEWAL 3 and 4
RENEWAL 3 and 4 AVT
RENEWAL RF
PRIZM 2 DR, Model 1861
Heart patients with a Guidant defibrillator should contact their doctor as soon as possible to determine if their model requires replacement, reprogramming or is not affected by the recall.
- Have you or someone you know been injured by a defective Guidant defibrillator?
- Has someone you know died due to a malfunctioning Guidant defibrillator?
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Guidant Defibrillator Links
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