Guidant CONTAK RENEWAL 4 AVT (model M170). Cardiac… recallZ-0827-06 · Guidant Corporation · initiated Apr 7, 2006

Why it was recalled

77 distributed devices may have a cracked layer of insulation in a flexible hybrid circuit, leading to internal shorting during charging such as during routine capacitor formation or for defibrillation. This would likely render the device non-functional, resulting in no output and/or telemetry communications.

FDA root cause category: Other

What the company is doing

Guidant Sales Representatives are retrieving non-implanted devices April 10-12, 2006. If a device is implanted the physician is sent an Urgent Medical Device Safety Information & Corrective Action letter, April 11-14, 2006. This letter describes the issue, states that Guidant is retrieving all non-implanted devices and that Guidant is currently conducting tests on retrieved devices. Physicians will be advised once more information is available.

Recall details

Recall number

Z-0827-06

Recall class

Not yet classified by the FDA

Status

Terminated

Initiated by the company

Apr 7, 2006

Posted by the FDA

May 2, 2006

Recalling firm

Guidant Corporation

Quantity

20 devices

Product code

NIK

FDA submissions

P010012

Distribution

Nationwide. AZ, FL, GA, IL, IN, KY, MA, ME, MI, MN, NC, NE, NY, OH, PA, TN, TX, UT, VA, WI. OUS to include: Australia, Canada, Germany, Italy, Netherlands, Portugal, Slovenia, Spain.

Product description

Guidant CONTAK RENEWAL 4 AVT (model M170). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Cardiac resynchronization therapy defibrillators (CRT-D) provide both atrial and ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricular tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with sudden cardiac death (SCD). Atrial tachyarrhythmia therapy is for the treatment of supraventricular tachcardia (SVT) and atrial fibrillation (AF). Cardiac resynchronization therapy is for the treatment of heart failure (HF) and uses biventricular electrical stimulation to synchronize ventricular contractions. This device also uses accelerometer-based adaptive-rate bradycardia therapy. Cardioversion/defibrillation therapies include a range of low-and high-energy shocks using either a biphasic or monophasic waveform.

Other devices under the same FDA submission

50 devices cleared under P010012 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• VIGILANT™ X4 CRT-D G247

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  17 deaths2,066 reports
• ACUITY™ X4 Spiral S 4674

  Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)
  16 deaths1,975 reports
• ACUITY™ X4 Straight 4671

  Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)
  5 deaths1,875 reports
• INOGEN™ X4 CRT-D G148

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  8 deaths1,252 reports
• RESONATE™ X4 CRT-D G447

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  13 deaths1,218 reports
• DYNAGEN™ X4 CRT-D G158

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  13 deaths1,166 reports
• MOMENTUM™ CRT-D G125

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  4 deaths792 reports
• MOMENTUM™ CRT-D G124

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  5 deaths790 reports
• ACUITY™ X4 Spiral L 4677

  Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)
  2 deaths729 reports
• EASYTRAK® 2 IS-1 4543

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  5 deaths727 reports
• RESONATE™ HF CRT-D G547

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death542 reports
• EASYTRAK® 2 IS-1 4542

  Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 deaths536 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 35166).

• Z-0825-06 · Terminated
  Guidant CONTAK RENEWAL 3 (models H170,H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100…
• Z-0826-06 · Terminated
  Guidant CONTAK RENEWAL 4 (models H190, H195) CONTAK RENEWAL; 4 HE (model H197). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Ha…
• Z-0828-06 · Terminated
  Guidant VITALITY HE Implantable Cardioverter Defibrillator (model T180). Sterile EO. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 551…