Z-0434-05

VISTA BRITE TIP RDC(1) Guiding Catheter. Product Code 67021055, lot X0704002, Precutaneous Catheter

Name: Z-0434-05 VISTA BRITE TIP RDC(1) Guiding Catheter. Product Code 67021055, lot X0704002, Precutaneous Catheter
Creator: Cordis Corporation
Published: 2004-12-07
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2004-12-07 / Terminated / root cause: manufacturing process

FDA source

Cordis Corporation began a recall of VISTA BRITE TIP RDC(1) Guiding Catheter. Product Code 67021055, lot X0704002, Precutaneous Catheter on 2004-12-07. The reason FDA records is "Two complaints have been received and confirmed, regarding a lot, indicating that the distal end had an 'RDC' shape rather than the 'RDC(1)' shape. The RDC shape has a larger curve. The product was manufactured with the...". 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-0434-05
Status: Terminated
Initiated: 2004-12-07
Posted: 2005-01-26
Terminated: 2008-11-19
Recalling firm: Cordis US Corp.
Product: VISTA BRITE TIP RDC(1) Guiding Catheter. Product Code 67021055, lot X0704002, Precutaneous Catheter.
Product code: DQY Catheter, Percutaneous
Reason for recall: Two complaints have been received and confirmed, regarding a lot, indicating that the distal end had an 'RDC' shape rather than the 'RDC(1)' shape. The RDC shape has a larger curve. The product was manufactured with the incorrect forming wire during the guiding catheter manufacturing process.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Packets containing the Customer Letter and Acknowledgement Form for each domestic consignee were sent by overnight delivery to the appropriate Cordis Endovascular sales representatives. The letter is being hand-delivered to each initial domestic consignee by the Cordis Endovascular sales representative. Any remaining units at the account will be removed from the shelf and returned to Cordis. The account will be asked to sign the Acknowledgement Form.
Quantity in commerce: 153 units
Distribution: Distributed to 57 accounts throughout the United States and three international accounts.
Product codes and lots: Product Code 67021055, lot X0704002

Product code DQY

K021593Class IIModification to Envoy and Vista Brite TipCordis Corp. / cleared 2002-06-13

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)