Recall Z-3055-2020 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
ev3 Inc.
Pacific Xtreme (PTCA Balloon Dilation Catheter)
| Date | Aug 26, 2020 |
| Status | Terminated |
| Reason | Labeling discrepancy for the Rated Burst Pressure (RBP) value. |
| Root cause | Under Investigation by firm |
| Action | On August 26th 2020 the firm send its consignees a letter. Customer Instructions: Medtronic records indicate that your facility has received one or more of the listed Pacific Xtreme PTA Balloon Catheter. As a result, Medtronic requests that you immediately take the following actions: 1.Identify and quarantine all affected and unused Pacific Xtreme PTA Balloon Catheters as listed in the enclosed Customer Notification Detail Report. 2.Return/Exchange all affected and unused Pacific Xtreme PTA Balloon Catheters in your inventory to Medtronic.Contact Medtronic Customer Service at 800-716-6700 to |
| Quantity | 4286 devices |
| Distribution | Domestic Distribution: AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL,IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX,VA, WA, WI and WV. International Distribution: Canada and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103464 | PACIFIC XTREME PTCA BALLOON DILATATION CATHETER Medtronic, Inc., Dec 22, 2010 |