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.
FDA Recall Z-2946-2011 · Posted 2011-08-04
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Recalling FirmVascular Solutions, Inc.
Recall StatusTerminated
Product CodeDXE
Date Initiated2011-07-11
Date Terminated2012-04-03
Product Quantity1086
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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