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Terminated

The Pronto Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

FDA Recall Z-1089-04 · Posted 2004-07-20

Recalling FirmVascular Solutions, Inc.
Recall StatusTerminated
Product CodeDXE
Date Initiated2004-05-12
Date Terminated2005-11-03
Product Quantity1010 of all affected lots

Reason for Recall

The marker band in guidewire lumen could move from the manufactured location during clinical use.

Firm Action

letter 5/21/2004, representative visit to foreign accounts.

Root Cause

Other

Distribution Pattern

Nationwide, worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032763VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETERVascular Solutions, Inc. · 2003-12-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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