Z-2946-2011

Vascular Solutions, Pronto V4, Extraction Catheter, Sterilized using ethylene oxide, Rx Only. The following...

Name: Z-2946-2011 Vascular Solutions, Pronto V4, Extraction Catheter, Sterilized using ethylene oxide, Rx Only. The following...
Creator: Vascular Solutions, Inc.
Published: 2011-07-11
License: https://open.fda.gov/license/

Vascular Solutions LLC / initiated 2011-07-11 / Terminated / root cause: manufacturing process

FDA source

Vascular Solutions, Inc. began a recall of Vascular Solutions, Pronto V4, Extraction Catheter, Sterilized using ethylene oxide, Rx Only. The following sizes/model numbers are affected: 5.5F( 4005)... on 2011-07-11. The reason FDA records is "Vascular Solutions , Inc recently discovered that there was a manufacturing defect with Pronto V4 extraction catheters (Models 4005, 4006, 4007, 4008). Use of this defective product could lead to a tip separation. This...". 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-2946-2011
Status: Terminated
Initiated: 2011-07-11
Posted: 2011-08-04
Terminated: 2012-04-03
Recalling firm: Vascular Solutions LLC
Product: Vascular Solutions, Pronto V4, Extraction Catheter, Sterilized using ethylene oxide, Rx Only. The following sizes/model numbers are affected: 5.5F( 4005), 6F(4006, 7F(4007, 8F(4008) are involved in the recall. The Pronto catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
Product code: DXE Catheter, Embolectomy
Reason for recall: Vascular Solutions , Inc recently discovered that there was a manufacturing defect with Pronto V4 extraction catheters (Models 4005, 4006, 4007, 4008). Use of this defective product could lead to a tip separation. This may cause injury and/or procedural delay, resulting in a deteriorating hemodynamic condition of the patient which may require medical intervention.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Vascular Solutions, Inc. sent an "URGENT: MEDICAL DEVICE FIELD ACTION" letter dated July 8, 2011 to all affected customers. The letter identifies the product, problem, and the actions to be taken by the customers. The letter instructs customers to identify the affected product and remove from current inventory. Included with the letter was a Field Action Customer Inventory Form for customers to complete and return. VSI will contact customers for replacement product upon receipt of the form and returned product. Contact your local representative for questions concerning this notice.
Quantity in commerce: 1086
Distribution: Nationwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DC, FL, ID, IL, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK ,OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV.
Product codes and lots: Model Lot # 4005 (5.5F) 551391 551513 551579 551861 4006(6F) 551034 551178 551514 551578 551581 551583 4007 (7F) 551106 551249 552116 4008 (8F) 551107551362 551577 552163

Product code DXE

K103405Class IIPronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter 6F; Pronto V4 Extraction 7F; Pronto V4 Extraction CathVascular Solutions, Inc. / cleared 2010-12-22

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)