Recall Z-0813-2012 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Medtronic Inc. Cardiac Rhythm Disease Management
Custom Packs/Mexico, Medtronic Cardio-Kit, Sterilized Using Ethylene Oxide, Nonpyrogenic, Rx Only. Model # DLP6N48R3 & DLP6N48R4. Medtronic Intersept Custom Tubing Pack with Trillium Biosurface, Sterilized Using Ethylene Oxide, , Model # TL4F71R1. These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiop
| Date | Jan 18, 2012 (initiated Dec 14, 2011) |
| Status | Terminated |
| Reason | Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated Instructions for Use. DO NOT USE THIS PRODUCT FOR EXTENDED TERMS SUCH AS VENTRICULAR ASSIST PROCEDURES. Medtronic has received two reports of patient deaths due to p |
| Root cause | Labeling design |
| Action | Medtronic sent an "URGENT MEDICAL DEVICE INFORMATION" letter dated December 2011 to all affected customers. The letter identifies the product, problem, and the action to be taken by the customers. Contract Medtronic CardioVascular LifeLine Technical Support at 1-877-526-7890 for questions related to this issue. |
| Quantity | 106 |
| Distribution | Worldwide Distribution-USA (nationwide) including Puerto Rico and the Virgin Islands and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bangladesh, Barbados, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Chile |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K891687 | EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE Medtronic Blood Systems, Inc., May 31, 1989 |