Class 2 Device Recall ProntoShort Extraction Catheter

• Date Initiated by Firm: November 20, 2009
• Date Posted: December 17, 2009
• Recall Status: Terminated on April 05, 2012
• Recall Number: Z-0547-2010
• Recall Event ID: 53938
• 510(K)Number: K051193
• Product Classification: Catheter, embolectomy - Product Code DXE
• Product: Vascular Solutions Pronto-Short Extraction Catheter. Model 5030. The PRONTO-Short Extraction catheter is a dual lumen, over-the-wire (OTW) catheter with related accessories. The catheter is designed to be delivered through a 6F or larger introducer sheath over the included 0.018" (0.45mm) guidewire. Sterilized with ethylene oxide. Manufactured by: Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369 USA.
• Code Information: Lot Numbers: 544202, 545693 and 546614.
• Recalling Firm/ Manufacturer: Vascular Solutions, Inc.; 6464 Sycamore Ct N; Maple Grove MN 55369-6032
• For Additional Information Contact: 763-656-4300
• Manufacturer Reason for Recall: It was found that three Pronto Short (model 5030) device lots were manufactured and labeled with an expiration date which is inconsistent than the expiration of the included guidewire component. The guidewire is sterilized separately and was realized to have an expiration date of October 31, 2009.
• FDA Determined Cause: Process control
• Action: Vascular Solutions issued an "Urgent: Medical Device Recall - Lot Specific" notification dated November 20, 2009, via USPS. The letter described the issue, identified affected product, asked for affected devices to be removed from inventory, quarantine, and call customer service for a Return Authorization number. Units will be replaced upon Vascular Solutions (VSI) receiving the returned devices. A Product Recall Inventory form was asked to be completed and faxed back to VSI. For further information, contact your local sales representative or Vascular Solutions Director of Marketing at 1-763-656-4300.
• Quantity in Commerce: 274 (150 US, 124 OUS)
• Distribution: Worldwide Distribution -- United States (CA, CO, FL, GA, IA, IL, IN, KS, LA, MI, MO, NC, NE, NH, NV, NY, OH, OR, PA, SC, TX, VA, VT, WA and WI), Canada, France, Ireland, Israel, Italy, Netherlands, Spain, Sweden, Taiwan and Turkey.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DXE and Original Applicant = VASCULAR SOLUTIONS, INC.