Recall Z-0475-2011 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic Sprint Quattro Secure, model 6947. Steroid eluting, quadripolar, screw-in, ventricular lead with Right Ventricular (RV) and superior vena cava (SVC) defibrillation coil electrodes. Contents Sterile. Manufactured in: Villalba, Puerto Rico, USA. Medtronic, Inc., Minneapolis, MN 55432 U.S.A.
| Date | Nov 26, 2010 (initiated Oct 25, 2010) |
| Status | Terminated |
| Reason | Over-retraction of the helix during initial implant or subsequent repositioning may result in the inability to extend the helix. This does not impact acute or chronic performance of successfully implanted leads. |
| Root cause | Device Design |
| Action | Medtronic issued an Important Medical Device Correction letter, dated October 2010, to doctors. The letter contains a Performance Note. The letter describes the issue and the performance note provides information on how to mitigate the issue through replacement with a new lead. Customers can contact Medtronic Technical Services at 800 723-4636 |
| Quantity | 154,000 total |
| Distribution | Worldwide Distribution: Throughout the US, including Guam, Puerto Rico, and US Virgin Islands, and to the countries of: Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bangladesh, Barbados, Belgium, Bolivia, Bosnia And Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, China |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.