Recall Z-0609-2009 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Medtronic Cardiovascular Revascularization & Surgical Therap
DLP(R) Pericardial/Intracardiac Sump Cannulae, 20 Fr., P/N: 12112. This product is intended for draining the pericardial sac or the cardiac chambers.
| Date | Jan 26, 2009 (initiated Sep 29, 2008) |
| Status | Terminated |
| Reason | Separates: Six complaints were received from two locations. In all cases the sump tip assembly separated from the tubing during device removal and had to be retrieved from the patient. There were no adverse events affecting these patients. |
| Root cause | Nonconforming Material/Component |
| Action | Consignees were sent a "Medtronic Urgent Medical Device Recall Notice" dated October 1, 2008. The letter described the product and issue. It also requested its customers to return the product and to complete, sign and fax the Recall Certificate "Medtronic Recall Certificate (FCA 0902)". For further information, please contact Medtronic Cardiovascular Revascularization & Surgical Therap by telephone at 763-391-9000. |
| Quantity | 380 US ; 180 OUS |
| Distribution | Worldwide Distribution --- including states of NC, PA, IA, WI, IN, VA, IL, KY, and TX, and countries of Australia, France, Hong Kong, Netherlands, and Poland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K850385 | INTRACARDIAC SUMP 12010 Dlp, Inc., Apr 29, 1985 |