Recall Z-1057-06 ยท DQY Catheter, Percutaneous
Medtronic, Inc.
5F ZUMA SR5.0 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM5SR50
| Date | Jun 1, 2006 (initiated Apr 5, 2006) |
| Status | Terminated |
| Reason | Potential for non-sterility due to loss of package integrity |
| Root cause | Other |
| Action | Medtronic notified accounts and sales representatives on 4/05/06 advising the recalled product be segregated and held for return to the sales rep. and documented on the reconciliation form. |
| Quantity | 36 units |
| Distribution | Nationwide Foreign: Austria, Australia, Bahrain, Bulgaria, Canada, Czech Republic, Denmark, Germany, Hungary, Italy, Jordan, France, Greece, Japan, Hong Kong, India, Italy, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990707 | MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS Medtronics Interventional Vascular, Mar 22, 1999 |