Recall of Guidant Pacemakers, ICDs
Thousands of Patients Implanted With Possibly Faulty Heart Devices
June 27, 2006 -- Boston Scientific says 27,200 patients -- 13,800 in the
U.S. -- have been implanted with possibly faulty heart devices made by its
recently acquired subsidiary, Guidant.
The devices contain a faulty capacitor that may cause them to fail. Five
failures have been reported -- four in patients already implanted, and one
during the implant operation. None of these patients died, although two
pacemaker patients fainted when their devices lost power.
Boston Scientific is recalling:
- Some Insignia and Nexus pacemakers
- Contak Renewal TR and TR 2 cardiac resynchronization pacemakers
- Ventak Prizm 2, Vitality, and Vitality 2 ICDs (implantable cardioverter
Last Friday, the company sent warning letters to doctors and patients. The
letters advise patients implanted with these devices to see their doctor as
soon as possible. It's not yet clear how many of the devices are faulty.
Company policy, subject to some restrictions, offers a replacement device at
no cost and up to $2,500 in unreimbursed medical expenses.
Boston Scientific says it is still investigating the failures, and will
promptly provide patients and doctors with any new information.
In a Monday news conference, Boston Scientific said it expects additional
recalls of Guidant heart devices. The current recall is the second. Last month,
the company announced that nearly 1,000 Guidant heart devices had a defect that
could cause their batteries to fail.
Boston Scientific recently acquired Guidant after a bidding war with Johnson
"Boston Scientific believes in notifying physicians in a timely,
transparent, and responsible manner," Boston Scientific CEO Jim Tobin said,
in a news release.