Z-0547-2010

Vascular Solutions Pronto-Short Extraction Catheter. Model 5030. The PRONTO-Short Extraction catheter is a...

Name: Z-0547-2010 Vascular Solutions Pronto-Short Extraction Catheter. Model 5030. The PRONTO-Short Extraction catheter is a...
Creator: Vascular Solutions, Inc.
Published: 2009-11-20
License: https://open.fda.gov/license/

Vascular Solutions LLC / initiated 2009-11-20 / Terminated / root cause: manufacturing process

FDA source

Vascular Solutions, Inc. began a recall of Vascular Solutions Pronto-Short Extraction Catheter. Model 5030. The PRONTO-Short Extraction catheter is a dual lumen, over-the-wire (OTW) catheter with... on 2009-11-20. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0547-2010
Status: Terminated
Initiated: 2009-11-20
Posted: 2009-12-17
Terminated: 2012-04-05
Recalling firm: Vascular Solutions LLC
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.
Product code: DXE Catheter, Embolectomy
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.
Root cause tag: manufacturing process
FDA root 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.
Product codes and lots: Lot Numbers: 544202, 545693 and 546614.

Product code DXE

K051193Class IIVascular Solutions Pronto Short Extraction CatheterVascular Solutions, Inc. / cleared 2005-08-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)