| | Class 2 Device Recall Pronto Extraction Catheter, Model 5000 |  |
| Date Initiated by Firm | May 12, 2004 |
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| Date Posted | July 20, 2004 |
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| Recall Status1 |
Terminated 3 on November 03, 2005 |
| Recall Number | Z-1089-04 |
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| Recall Event ID |
29391 |
| 510(K)Number | K032763 |
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| Product Classification |
Catheter, Embolectomy - Product Code DXE
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| Product | The Pronto Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system. |
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| Code Information |
lot numbers S000121, S000122, 300748, 300783, 300784, 300792, and 300822. |
| FEI Number |
3002827704
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Recalling Firm/
Manufacturer |
Vascular Solutions, Inc.
6464 Sycamore Ct.
Minneapolis MN 55369
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Manufacturer Reason
for Recall | The marker band in guidewire lumen could move from the manufactured location during clinical use. |
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FDA Determined
Cause 2 | Other |
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| Action | letter 5/21/2004, representative visit to foreign accounts. |
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| Quantity in Commerce | 1010 of all affected lots |
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| Distribution | Nationwide, worldwide |
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| Total Product Life Cycle | TPLC Device Report |
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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.
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| 510(K) Database | 510(K)s with Product Code = DXE
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