FDA Recall Terminated

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.

Recall: Z-0547-2010 · Initiated November 20, 2009

Recall

Recall Number: Z-0547-2010
Event Number: 53938
Firm: Vascular Solutions, Inc.
FEI Number: 3002827704
Product Code: DXE
Status: Terminated
Root Cause: Process control
Initiated: November 20, 2009
Posted: December 17, 2009
Terminated: April 5, 2012
Address: 6464 Sycamore Ct N, Maple Grove, MN, 55369-6032

Description

Reason

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.

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.

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.

Quantity

274 (150 US, 124 OUS)