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Boston Scientific Recalls Pacemakers and Defibrillators

Patients with affected devices should be called in for device function assessment

TUESDAY, June 27 (HealthDay News) -- Boston Scientific Corporation has recalled a subset of cardiac devices including Insignia and Nexus pacemakers, Contak Renewal TR/TR2 cardiac resynchronization pacemakers and Ventak Prizm 2, Vitality and Vitality 2 implantable cardioverter defibrillators, manufactured by the company's Cardiac Rhythm Management (CRM) Group. The group was formerly Guidant's CRM business, acquired by Boston Scientific in April this year.

The reason for the recall was the suboptimal performance of a supplier's low-voltage capacitor, which may cause devices to malfunction, resulting in premature battery depletion or even loss of therapy. Of the 27,200 devices in this subset, there have been five confirmed events so far, of which four were detected after implantation. Two patients experienced syncope due to loss of pacing output, but there have been no deaths associated with the products under recall.

The company recommends physicians schedule a follow-up examination for patients fitted with these implants in order to check for any signs of malfunction. "At this follow-up visit, physicians should look for behaviors that may be indicative of capacitor malfunction such as premature battery depletion, intermittent or permanent loss of therapy or telemetry, fault codes, pacing or sensing abnormalities, or loss of daily measurements," according to a company statement.

More Information
More Information - Letter to Physicians
More Information - Letter to Patients

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