Guidant, CONTAK RENEWAL 3/3RF Models H170, H175, H177, H179, H210, H215, H217, H219, Guidant Corporation, 4100 Hamline A

FDA device recall Z-0016-2011 · posted 2010-10-07 · Terminated

Recall details

Recalling firm

Boston Scientific CRM Corp

Reason for recall

Exposure to a magnet (typically in a clinic/hospital environment) may cause a magnetic reed switch to become permanently stuck in a closed position in certain Boston Scientific CRT-Ds and ICDs (CONTAK RENEWAL 3 / 3 RF / 4 / 4 RF and VITALITY HE implantable defibrillators). This prevents delivery of programmed tachy therapy, and use of the Patient Triggered Monitor feature. This issue may require

Action taken

Boston Scientific Issued Urgent Medical Device Correction and Physician Device Advisory Notice letters dated July, 2010 to customers identifying the affected devices, the issue prompting the recall, clinical implications, and actions to be taken by customers. Customers were instructed: 1) Physicians should continue routine follow-up sessions, and patients should be reminded to contact their clinic or go to the hospital emergency room immediately if they hear tones/beeps from their device. 2) In a hospital/clinic/surgery setting, if tones are heard upon magnet application but do not cease upon magnet removal, the device should be interrogated with a programmer and checked per normal standard of care. 3) In the United States, use of the LATITUDE remote patient monitoring system may help identify loss of daily measurements and thereby facilitate timely detection of a stuck reed switch. [NOTE 1: A pop-up message and/or LATITUDE alert do not appear for missing Daily Measurements. NOTE 2: Daily Measurements may be unavailable for reasons other than a stuck switch.] 4) Prophylactic explant is NOT recommended. 5) If a stuck magnetic switch is confirmed, program the Enable Magnet Use feature to Off, which ensures that programmed therapy will be provided to treat tachyarrhythmias. However, if Enable Magnet Use is programmed Off, a magnet will no longer inhibit tachy therapy, and the Patient Triggered Monitor feature will no longer be available. Do not routinely program Enable Magnet Use to Off in the absence of a confirmed stuck magnetic reed switch because the benefits of magnet use to disable tachy therapy in emergent situations outweigh the probability of patient harm associated with a stuck reed switch. In the US, Boston Scientific Cardiac Rhythm Management can be contacted at 800-227-3422, and in Europe, Boston Scientific Europe S.A. can be contacted at +32 2 416 7222.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LWP

Quantity affected

32,556

Distribution

Worldwide Distribution: All States in the continental USA including PR and DC , but excluding VT, the countries of Canada, Mexico, and in Europe. ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BERMUDA, BRITI

Date initiated

2010-07-22

Date posted

2010-10-07

Date terminated

2012-04-03

Location

Saint Paul, MN