VITALITY DR+ Implantable Cardioverter Defibrillator (ICD), model 1872
This recall has been terminated (originally issued August 21, 2008).
- Company
- Boston Scientific Crm Corp
- Recall Initiated
- January 7, 2008
- Posted
- August 21, 2008
- Terminated
- December 30, 2008
- Recall Number
- Z-1513-2008
- Quantity
- BSC CRM estimates that the number of devices implanted in a susceptible orientation is likely less than 1% of the total active implants 25,000 (w.w.)
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Repetitive mechanical stress applied to the titanium case can induce component damage and device malfunction in certain ICD and CRT-D devices implanted subpectorally with the serial number facing the ribs. Devices implanted subcutaneously or in a subpectoral position with the serial number facing away from the ribs are not included in this advisory. This update identifies additional VITALITY ICD
Distribution
Nationwide and Worldwide: Bolivia, Panama, Iran, Saudi Arabia, Kuwait, United Arab Rep., Austria, Belgium, Cyrus, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, UK, India, Australia, New Zealand, Malaysia, Singapore, Hong Kong, China, Israel, Turkey, Thailand, and Canada.
Lot / Code Info
Devices that are implanted subpectorally with the serial number facing the ribs. Implant orientation is not reported to Boston Scientific CRM.
Root Cause
Device Design
Action Taken
An Urgent Medical Device Information Update to May 2006 Product Advisory, dated January 04, 2008, was sent to implanting physicians and physicians following implanted devices beginning Monday, January 07, 2008. The letter described a malfunction that can occur when the ICD is implanted subpectorally with the serial number facing the ribs. Devices implanted subcutaneously or in a subpectoral position with the serial number facing away from the ribs are not included in this advisory. The physicians were asked to review records to determine if an affected device was implanted subpectorally. An AP radiograph should be done to determine specific device orientation for subpectoral implants. If a subpectoral implant is in a susceptible orientation, consider repositioning or replacement for physically active patients who regularly need device therapy. Follow patients with susceptible devices at 3-month intervals.