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.
This recall has been terminated (originally issued December 17, 2009).
- Company
- Vascular Solutions, Inc.
- Recall Initiated
- November 20, 2009
- Posted
- December 17, 2009
- Terminated
- April 5, 2012
- Recall Number
- Z-0547-2010
- Quantity
- 274 (150 US, 124 OUS)
- Firm Location
- Maple Grove, MN
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
Lot Numbers: 544202, 545693 and 546614.
Root Cause
Process control
Action Taken
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.