Recall Z-0900-2014 ยท ITX Transducer, Ultrasonic, Diagnostic
Boston Scientific Corporation
Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R; Sterilized using irradiation. Product Usage: This catheter is a 15 MHz ultrasound imaging catheter intended to operate with an IVUS instrument for diagnostic imaging. It is used with an 8.5F-introducer sheath and a 0.035 guidewire.
| Date | Jan 30, 2014 (initiated Jan 6, 2014) |
| Status | Terminated |
| Reason | Reports of physicians experiencing inability to pass a 0.035" guidewire through the guidewire lumen and exit port at the (proximal) Y-manifold of the imaging catheter. |
| Root cause | Equipment maintenance |
| Action | Boston Scientific sent an Urgent Medical Device Recall Removal letter dated January 14, 2014 to all affected customers by overnight mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete an Account Reply verification Tracking Form in order to received a Return Goods Authorization number for product return. For questions contact your local Sales Representative. |
| Quantity | 1068 single units |
| Distribution | US Nationwide Distribution and Mexico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080272 | ATLANTIS PVIMAGING CATHETER, MODEL H749364560 Boston Scientific Corp, Mar 11, 2008 |