VISTA BRITE TIP RDC(1) Guiding Catheter. Product Code… recallZ-0434-05 · Cordis Corporation · initiated Dec 7, 2004
Terminated All recalls posted in January 2005
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cordis Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0434-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 7, 2004
- Posted by the FDA
- Jan 26, 2005
- Recalling firm
- Cordis Corporation
- Quantity
- 153 units
- Product code
- DQY
- FDA submissions
- K021593
- Distribution
- Distributed to 57 accounts throughout the United States and three international accounts.
Product description
VISTA BRITE TIP RDC(1) Guiding Catheter. Product Code 67021055, lot X0704002, Precutaneous Catheter.
Code information (models, lots, serial numbers)
Product Code 67021055, lot X0704002
Other devices under the same FDA submission
10 devices cleared under K021593 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- VISTA BRITE TIP SM7504Cordis Corporation · CATHETER, PERCUTANEOUS1 recall0 reports
- CORDIS 67000400Cordis US Corp. · CATHETER, INTRAVASCULAR, DIAGNOSTIC6 reports
- CORDIS 67000200Cordis US Corp. · CATHETER, INTRAVASCULAR, DIAGNOSTIC4 reports
- VISTA BRITE TIP 670-052-00MCordis US Corp. · Catheter, percutaneous3 reports
- VISTA BRITE TIP 6700540ECordis Corporation · CATHETER, PERCUTANEOUS2 reports
- VISTA BRITE TIP 6700820ECordis Corporation · CATHETER, PERCUTANEOUS2 reports
- CORDIS 67000000Cordis Corporation · CATHETER, INTRAVASCULAR, DIAGNOSTIC2 reports
- CORDIS 67000300Cordis US Corp. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 report
- VISTA BRITE TIP 6700820LCordis Corporation · CATHETER, PERCUTANEOUS1 report
- BRITE TIP 55608200Cordis US Corp. · CATHETER, PERCUTANEOUS1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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