Recall Z-0016-2011 ยท LWP Implantable Pulse Generator, Pacemaker (Non-Crt)
Boston Scientific CRM Corp
Guidant, CONTAK RENEWAL 3/3RF Models H170, H175, H177, H179, H210, H215, H217, H219, Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 CONTAK RENEWAL 4/4RF Models H190*, H195*, H197*, H199*, M170*, M175*, M177*, M179*, H230*, H235*, H239* *Not available in the US
| Date | Oct 7, 2010 (initiated Jul 22, 2010) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 |
| Quantity | 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, BRITISH VIRGIN ISLANDS, CANADA, CAYMAN ISLANDS, CHILE, COSTA RICA, CYPRUS, CZECH REPUBLIC, CZECHOSLOVAKI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.