Recall Z-1617-2008 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Boston Scientific Corp
Boston Scientific SteeroCath-T Ablation Catheter. This catheter is indicated for general indications, treatment of supraventricular tachycardia (svt) and ventricular tachycardia (vt). This product in not indicated for use as an ablation catheters indicated for treatment of atrial flutter or for atrial fibrillation.
| Date | Aug 30, 2008 (initiated Feb 14, 2008) |
| Status | Terminated |
| Reason | Package sterile barrier may be breached, compromising sterility. |
| Root cause | Nonconforming Material/Component |
| Action | Recall initiated on Feb. 14, 2008, via Urgent Medical Device Recall notification being sent to consignees, along with a reply verification tracking form. If you have questions or need a copy of the recall notification, contact Deborah J. Springer at 1-408-935-4944 or springed@bsci.com. |
| Quantity | 827 units total |
| Distribution | Worldwide Distribution --- including USA and countries of Saudi Arabia, Spain, Italy, Israel, Denmark, Canada and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.