Recall Z-0707-05 ยท MAF Stent, Coronary
Guidant Corporation Advanced CardiovascularSystem
Voyager RX Coronary Dilatation Catheter
| Date | Apr 13, 2005 (initiated Jan 27, 2005) |
| Status | Terminated |
| Reason | Leak at guide wire exit notch could introduce air into the artery. |
| Root cause | Other |
| Action | Firm notified affiliates in foreign countries and distributors of the recall on 01/27/2005. Recall is on-going. |
| Quantity | 180,000 units |
| Distribution | Worldwide. Direct to customers in: Austria, Belgium & Luxumburg, Canada, Czech Republic, Denmark, France, Germany, Italy, The Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, The UK. To Distributors in: Finland, Iceland, Ireland, Lithuania, Barhain, Bulgaria, Cypres, Greece, Hungary, Isr |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.