Recall Z-1939-2010 ยท DWA Control, Pump Speed, Cardiopulmonary Bypass
Medtronic Cardiovascular Revascularization & Surgical Therap
Hospital Grade Power Cord, UL, Part # 66319, 055476, manufactured by Electri-Cord Manufacturing Co. beginning in February 2003. The cords are a detachable unit, supplied with the instruments listed below: Medtronic Bio-Console 550 centrifugal pump console, Model #95180, Catalogue # 95180, E95180, R95180. Medtr
| Date | Jun 30, 2010 (initiated Apr 21, 2010) |
| Status | Terminated |
| Reason | The potential risks during the use of this power cord include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires. Although Medtronic has received no reports of adverse events related to the affected cord, a failure may potentially lead to serious adverse health consequences, depending on the device, and therapy being interrupted. This Field Notificatio |
| Root cause | Nonconforming Material/Component |
| Action | Consignees were sent on 4/21/10 a Medtronic "Urgent Medical Device Recall Notice" letter dated April 19, 2010. The letter was addressed to their customers and described the problem and the product involved. They recommended to discontinue use of the AC power cords and to destroy them. Requested consignees to fill out the attached Medtronic Recall Certificate (FCA 1005), and return it to Medtronics. |
| Quantity | 619 USA, 80 OUS |
| Distribution | Worldwide distribution: USA, Latin America, Middle East, Japan, and Canada. |
| FDA record | Open on fda.gov |