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U.S. Department of Health and Human Services

Class 2 Device Recall Vitality HE Model T180 Implantable Cardioverter Defibrillator (ICD)

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 Class 2 Device Recall Vitality HE Model T180 Implantable Cardioverter Defibrillator (ICD) see related information
Date Posted October 07, 2010
Recall Status1 Terminated on April 03, 2012
Recall Number Z-0017-2011
Recall Event ID 56630
PMA Number P960040S053 
Product Classification Implantable pulse generator, pacemaker (non-crt) - Product Code KRG
Product Guidant, Vitality HE ICD, Model: T180DDR, Sterile Lot, Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798.
Code Information 209282
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SERIAL
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Recalling Firm/
Manufacturer
Boston Scientific CRM Corp
4100 Hamline Ave N
Saint Paul MN 55112-5700
For Additional Information Contact
651-582-4000
Manufacturer 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
FDA Determined
Cause 2
Nonconforming Material/Component
Action 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.
Quantity in Commerce 5821
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, BRITISH VIRGIN ISLANDS, CANADA, CAYMAN ISLANDS, CHILE, COSTA RICA, CYPRUS, CZECH REPUBLIC, CZECHOSLOVAKIA, DENMARK, EGYPT, FINLAND, FRANCE, FRENCH POLYNESIA, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KOREA, KUWAIT, LEBANON, LUXEMBOURG, MALAYSIA, MEXICO, NETHERLANDS,NEW ZEALAND, NORWAY, POLAND, PORTUGAL , QATAR, SAINT KITTS & NEOIS, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED KINGDOM,VENEZUELA, URUGUAY, ZIMBABWE, IRAN.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database
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