Z-1089-04

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

Name: Z-1089-04 The Pronto Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in...
Creator: Vascular Solutions, Inc.
Published: 2004-05-12
License: https://open.fda.gov/license/

Vascular Solutions LLC / initiated 2004-05-12 / Terminated / root cause: manufacturing process

FDA source

Vascular Solutions, Inc. began a recall of The Pronto Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system on 2004-05-12. The reason FDA records is "The marker band in guidewire lumen could move from the manufactured location during clinical use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1089-04
Status: Terminated
Initiated: 2004-05-12
Posted: 2004-07-20
Terminated: 2005-11-03
Recalling firm: Vascular Solutions LLC
Product: The Pronto Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.
Product code: DXE Catheter, Embolectomy
Reason for recall: The marker band in guidewire lumen could move from the manufactured location during clinical use.
Root cause tag: manufacturing process
FDA root cause: Other
Action: letter 5/21/2004, representative visit to foreign accounts.
Quantity in commerce: 1010 of all affected lots
Distribution: Nationwide, worldwide
Product codes and lots: lot numbers S000121, S000122, 300748, 300783, 300784, 300792, and 300822.

Product code DXE

K032763Class IIVascular Solutions Pronto Extraction CatheterVascular Solutions, Inc. / cleared 2003-12-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)