Boston Scientific LIVIAN Cardiac Resynchronization Therapy… recallZ-1556-2010 · Boston Scientific CRM Corp · initiated Mar 15, 2010

Why it was recalled

Boston Scientific Corporation has stopped shipment and is retrieving unimplanted devices from US hospital shelves of all its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) after determining that some manufacturing process changes were not submitted for approval to the US Food & Drug Administration.

FDA root cause category: PMA

What the company is doing

BSC issues press release dated 15 March 2010. FDA press release posted 18 March 2010. On 15 March 2010, BSC Sales Representatives begin removal of devices from health care facilities stock. Starting 22 March 2010 BSC sent a physician letter dated 22 March 2010 to implanting and following physicians via FedEx. The Urgent Medical Device Recall letter described the issue of why devices were being removed from hospital shelves. The letter did NOT recommend any changes to normal follow-up procedures for patients implanted with an ICD or CRT-D device. The letter included ALL potential US models. To be complete and mitigate the possibility of retrieval errors, the ICD and CRT-D US models that may be on customer's shelves were included in the letter. The devices subject to retrieval, however, were those non-implanted devices with domestic customers. For questions, please contact the local representative (1-800-227-3422) for pick up and return or contact Boston Scientific Technical Services at 1.800.CARDIAC (227.3422).

Recall details

Recall number

Z-1556-2010

Recall class

Not yet classified by the FDA

Status

Terminated

Initiated by the company

Mar 15, 2010

Posted by the FDA

May 8, 2010

Recalling firm

Boston Scientific CRM Corp

Quantity

135

Product code

LWP

FDA submissions

P010012

Distribution

nationwide within US only (OUS distribution not affected).

Product description

Boston Scientific LIVIAN Cardiac Resynchronization Therapy Defibrillator (CRT-D), models H220, H225, H227, H229. The LIVIAN family of cardiac resynchronization therapy defibrillators (CRT-Ds), 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. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue, St. Paul, MN 55112-5798 USA.

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 55216).

• Z-1555-2010 · Terminated
  Boston Scientific CONFIENT, model E030, Implantable Cardioverter Defibrillator (ICD). The CONFIENT Implantable Cardioverter Defibrillator (ICDs) are designed to detect and termina…