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.
Recall
- Recall Number
- Z-0900-2014
- Event Number
- 67298
- Firm
- Boston Scientific Corporation
- FEI Number
- 2939204
- Product Code
- ITX
- Status
- Terminated
- Root Cause
- Equipment maintenance
- Initiated
- January 6, 2014
- Posted
- January 30, 2014
- Terminated
- October 29, 2014
- Address
- 47215 Lakeview Blvd, Fremont, CA, 94538-6530
Description
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.
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.
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.
US Nationwide Distribution and Mexico
1068 single units