Recall Z-1844-2015 ยท OBJ Catheter, Ultrasound, Intravascular
Volcano Corporation
Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is indicated for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The device is an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements
| Date | Jun 25, 2015 (initiated Jun 4, 2015) |
| Status | Terminated |
| Reason | During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture |
| Root cause | Labeling mix-ups |
| Action | Volcano sent an Urgent Medical Device Recalls lettersdated June 4, 2015 via Federal Express to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine product inventory, quarantine the affected product, complete the attached Customer Return form, and contact Volcano Customer Service at 800-228-4728, option 4 to arrange for the return of any product in inventory. |
| Quantity | 162 total devices (included both products) |
| Distribution | US Nationwide Distribution and one account in Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121273 | VISIONS PV .035 DITITAL IVUS CATHETER Volcano Corporation, Sep 10, 2012 |