Guidant Recall
On June 17, 2005, Guidant issued a voluntary recall of its implanted cardiac defibrillator. The Guidant recall is linked to at least 45 failures of the device and the deaths of two patients.
Guidant Defibrulator Lawsuit

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About Pacemakers
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FDA Recalls Guidant Pacemaker
Guidant Pacemaker Recall
Guidant Press Release
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Recalled Defribrillators
Recent FDA Updates Concerning Guidant

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Implanted Pacemakers

What is it?
 

A pacemaker is a small, battery-powered device that is implanted permanently into the body. The pacemaker monitors the electrical impulses in the heart and, when needed, delivers electrical stimuli to make the heart beat (contract) in a more normal rhythm.

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When is
it used?
A pacemaker is used when the heart beats too slowly (bradycardia) or has other abnormal rhythms (arrhythmias). In some cases, pacemakers are also used to treat the symptoms of heart failure.
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How does
it work?

A pacemaker consists of a battery and electrical circuitry (pulse generator). The battery powers the pacemaker. The circuitry checks the heart rate and produces tiny electrical pulses that keep the heart beating at the correct pace.

The pacemaker is connected to the heart through one to three insulated wires (leads) that are attached directly to the heart's chambers.

Some pacemakers can be customized to meet specific needs.

  • Rate-Responsive Pacemakers These pacemakers may be programmed to increase or decrease heart rate to match your activities (i.e. resting or walking).
     
  • Single-Chambered Pacemakers These pacemakers use only one lead placed into the right upper chamber of the heart (right atrium) or the right lower chamber (right ventricle).
     
  • Dual-Chambered Pacemakers These pacemakers have two leads. One is placed in the right atrium, the other in the right ventricle.
     
  • Cardiac Resynchronization Therapy Pacemakers These pacemakers have three leads. One is in the right atrium, one is in the right ventricle, and one is placed through the heart’s veins to the left ventricle.
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What will it accomplish? A pacemaker can restore a normal heart rate so that the heart can pump more effectively. This can reduce or stop the symptoms of abnormal heartbeats (arrhythmias), such as dizziness, confusion, fainting, or fatigue.
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What are
the risks?
Risks Due to Surgical Procedure
Risks from the surgery to implant the pacemaker include:
  • Bleeding
  • Swelling or bruising under the skin
  • Blood clot formation
  • Infection
  • Blood vessel damage

Your doctor will tell you about additional risks from the surgical procedure.

Need For Additional Surgeries To Replace Or Repair Pacemaker

Electromagnetic Interference Some devices in your surroundings may interfere with your cardiac pacemaker. Currently available pacemakers are more resistant to this problem than earlier models. Always carry your wallet I.D. card with you.
  • Household devices and appliances may cause the pacemaker to enter a mode to prevent inappropriate behavior or cause it to stop delivering therapy until the interference source is removed.
  • Some medical equipment can damage your pacemaker. If you are visiting your doctor or dentist, tell him or her that you have a pacemaker BEFORE they do any testing or treatment.
  • Some security devices may temporarily stop your pacemaker from working properly or give you cardiac symptoms. A general rule of thumb is “Don’t lean, don’t linger” when moving through these devices.
  • Welders and electric generators may stop your pacemaker from working properly.
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When should
it not be used?

A pacemaker should not be implanted in people who cannot tolerate the device or the surgical procedure, or who are sensitive (allergic) to the exposed parts of the pacing system.

Some pacemakers are designed to treat only specific conditions and should not be used to treat other conditions.

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Guidant Recall Defibrillators

 

Guidant Pacemakers Recalled

 

Guidant CRT and Defibrillator Model Numbers:

 

Guidant Pacemaker Model Numbers Recalled:

  • 0470
  • 0476
  • 0481
  • 0870
  • 0970
  • 0972
  • 0976
  • 0981
  • 1170
  • 1171
  • 1172
  • 1174
  • 1175
  • 1176
  • 1180
  • 1181
  • 1184
  • 1186
  • 1187
  • 1241
  • 1270
  • 1272
  • 1273
  • 1274
  • 1275
  • 1276
  • 1280
  • 1283
  • 1284
  • 1285
  • 1286
  • 1349
  • 1380
  • 1384
  • 1385
  • 1480
  • 1483
  • 1484
  • 1485
  • 1499

CRT

  • Contak Renewal
  • Contak Renewal 2
  • Contak Renewal 3 (Class II)
  • Contak Renewal 4 (Class II)
  • Contak Renewal Model H135 (Class I)
  • Contak Renewal Model H155 (Class I)
  • Renewal AVT (Class II)
  • Renewal 3 AVT (Class II)
  • Renewal 4 AVT (Class II)
  • Renewal RF (Class II)

 

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