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U.S. Department of Health and Human Services

Class 2 Device Recall Vascular Solutions, Pronto V4, Extraction Catheter

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  Class 2 Device Recall Vascular Solutions, Pronto V4, Extraction Catheter see related information
Date Initiated by Firm July 11, 2011
Date Posted August 04, 2011
Recall Status1 Terminated 3 on April 03, 2012
Recall Number Z-2946-2011
Recall Event ID 59368
510(K)Number K103405  
Product Classification Catheter, embolectomy - Product Code DXE
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.
Code Information 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
Recalling Firm/
Manufacturer		 Vascular Solutions, Inc.
6464 Sycamore Ct N
Maple Grove MN 55369-6032
For Additional Information Contact
763-656-4300
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DXE and Original Applicant = VASCULAR SOLUTIONS, INC.
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