Guidant CONTAK RENEWAL 3 (models H170, H175) CONTAK RENEWAL… recallZ-1288-06 · Boston Scientific CRM Corp · initiated May 15, 2006

Why it was recalled

Guidant has identified a pattern of premature battery depletion in devices manufactured with a single lot of capacitors from a single supplier. If function of this low voltage capacitor is compromised, the battery may deplete prematurely.

FDA root cause category: Other

What the company is doing

An Urgent Medical Device Safety Information & Corrective Action letter, dated May 12, 2006, was sent to physicians. The letter gave a description of the issue, clinical implications, rate of occurrence, devices affected and recommendation. Physicians are asked to follow-up with affected patients as soon as possible because ERI to EOL time may be shortened. Physicians are asked to contact Guidant for instructions on performing a baseline 'save to disk' and provide this information to Guidant. Guidant will be able to analyze the device memory data and estimate remaining longevity and provide individualized follow-up and replacement guidelines. Subsequent follow-up visits should continue to monitor for evidence of premature battery depletion.

Recall details

Recall number

Z-1288-06

Recall class

Not yet classified by the FDA

Status

Terminated

Initiated by the company

May 15, 2006

Posted by the FDA

Jul 27, 2006

Recalling firm

Boston Scientific CRM Corp

Quantity

59

Product code

NIK

FDA submissions

P010012

Distribution

Nationwide including Puerto Rico. Worldwide, including Argentina, Belgium, Canada, Denmark, France, Germany, Greece, Ireland, Italy, Netherlands, New Zealand, Portugal, Spain, Syrian Arab Republic, United Arab Emirates

Product description

Guidant CONTAK RENEWAL 3 (models H170, H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Cardiac resynchronization therapy defibrillators (CRT-D) provide 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). Cardiac resynchronization therapy is for the treatment of heart failure (HF) and uses biventricular electrical stimulation to synchronize ventricular contractions. 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 35525).

• Z-1292-06 · Terminated
  Guidant VITALITY 2 (models T165, T175), VITALITY DS (model T125), VITALITY EL (model T135), Implantable Cardioverter Defibrillators (ICD), are designed to detect and terminate ven…