Recall Z-0868-2013 ยท DQY Catheter, Percutaneous
Vascular Solutions, Inc.
Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide, Rx Only, Model numbers 5300 - 5307, 5324, 5325, 5329, 5332, 5336, 5340, and 5341. Product Usage: The SuperCross catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidew
| Date | Feb 20, 2013 (initiated Jan 29, 2013) |
| Status | Terminated |
| Reason | Vascular Solutions, Inc has discovered a potential problem with a number of lots of Supercross microcatheters. A potential for surface contamination on aged catheters was observed during in-house testing. |
| Root cause | Material/Component Contamination |
| Action | Vascular Solutions sent an "Urgent Medical device Recall" letter dated January 28, 29013 to all affected customers. The letter identified the affected product, described the problem and actions to be taken. The letter advised customers to remove the product from their inventory and to complete and return the VSI Account Inventory Form. For questions contact your local Sales Representative. |
| Quantity | 4731 |
| Distribution | Worldwide Distribution - USA Nationwide including the states of AL, AZ, AR, CA, CO, CT, DE, CD, FL, GA, HI, ID, IL ,IN, IA, KY, LA, ME, MD, MA, MI,MN, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT VA, WA, WV, WI, WY and AUSTRIA, CANDA, DENMARK, FINLAND, FRANCE, GERMA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101659 | SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301 Vascular Solutions, Inc., Dec 16, 2010 |