Recall Z-1655-2012 ยท DQY Catheter, Percutaneous
Vascular Solutions, Inc.
Vascular Solutions, GuideLiner V2 Catheter, Rx only, Sterile EO, Catalog Number 5571, 6F, Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369. Intended to be used in conjunction with guide catheters to access discrete regions of the coronary and or peripheral vasculature and too facilitate placement and exchange of guidewired and other interventional devices.
| Date | May 24, 2012 (initiated Jan 17, 2012) |
| Status | Terminated |
| Reason | Vascular Solutions has became aware of a potential defect with their 6F GuideLiner V2 catheters (Model 5571) with lot number 555038. Use of this product could result in the catheter shaft separating from the pushwire on the device. This may cause a procedural delay and/or injury possibly requiring medical intervention. |
| Root cause | Material/Component Contamination |
| Action | Vascular Solutions sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 17, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory for the affected product , immediately remove the product and place the product in a secure area. Additionally, customers were asked to complete and return a Field Action Customer Inventory Form to the Customer Service Department via fax at 763-656-4251 or e-mail at customerservice@vasc.com. Customers may contact their local sales repre |
| Quantity | 330 |
| Distribution | Nationwide Distribution including the states of AL, AZ, AR, CO, CT, DC, FL, GA, HI, IL, IN, IA, KS, KY, LAM ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, WA, WV, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112082 | GUIDELINER V2 CATHETER Vascular Solutions, Inc., Dec 1, 2011 |