Recall Z-0050-2008 ยท LWP Implantable Pulse Generator, Pacemaker (Non-Crt)
Boston Scientific CRM Corp
Guidant VITALITY DS DR/VR (Models T125, T135), Guidant VITALITY EL (Model T127), Guidant VITALITY DR HE (Model T180), Implantable Cardioverter Defibrillators (ICD). Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.
| Date | Nov 24, 2007 (initiated Mar 16, 2007) |
| Status | Terminated |
| Reason | Atypical Charge Time Behavior: 1)-End of Life (EOL) or ERI is displayed during mid-life (typically 24-48 months), even though battery capacity remains available. 2)- Extended ERI charge time limits: Charge times during mid-life may remain below a normal extension of the ERI charge time . ****** Prophylactic replacement of these devices prior to ERI is not recommended. As stated in the Product U |
| Root cause | Device Design |
| Action | A Product Update titled "ERI Charge Time Limit Extended During Mid-Life and Mid-Life Display of Replacement Indicators", dated 03/10/2007 was posted to Company's website on 03/13/2007. A CRM Product News letter was sent to physicians beginning 03/16/2007. The CRM Product News Letter gave an overview of the content of the Product Update and stated the web location for finding the complete Product Update. The Product Update identified affected devices, gave an overview of normal charge time behavior at mid-life for specific ICD and CRT-D devices. The letter also described the atypical charge |
| Quantity | 19,609 within USA, 18 Foreign-Recalled units only cover devices implanted prior to July 2005 |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.