Vascular Solutions, Pronto V4, Extraction Catheter… recallZ-2946-2011 · Vascular Solutions, Inc. · initiated Jul 11, 2011
Terminated All recalls posted in August 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Vascular Solutions, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-2946-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jul 11, 2011
- Posted by the FDA
- Aug 4, 2011
- Recalling firm
- Vascular Solutions, Inc.
- Quantity
- 1086
- Product code
- DXE
- FDA submissions
- K103405
- 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 description
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.
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
4 devices cleared under K103405 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- PRONTO IPN913531Teleflex Incorporated · Catheter, embolectomy4 reports
- PRONTO IPN913530Teleflex Incorporated · Catheter, embolectomy1 death2 reports
- Pronto® V4 extraction catheter 4006Vascular Solutions, Inc. · Catheter, Embolectomy2 reports
- PRONTO IPN922584Teleflex Incorporated · Aspiration thrombectomy catheter1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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