FDA Medical Device Recalls (openFDA)
Cordis Corporation: VISTA BRITE TIP RDC(1) Guiding Catheter. Product Code 67021055, lot X0704002, Precutaneous Catheter.
- Recall number
- Z-0434-05
- Recalling firm
- Cordis Corporation
- Product
- VISTA BRITE TIP RDC(1) Guiding Catheter. Product Code 67021055, lot X0704002, Precutaneous Catheter.
- Status
- Terminated
- Initiated
- 2004-12-07
- Posted
- 2005-01-26
- Terminated
- 2008-11-19
- Reason
- 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
- 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
- 153 units
- Distribution
- Distributed to 57 accounts throughout the United States and three international accounts.
- Lot, serial or model codes
- Product Code 67021055, lot X0704002
- 510(k) numbers
- ["K021593"]
- PMA numbers
- not on file
- Product code
- DQY
- Firm FEI
- 1016427
- Firm city
- Miami Lakes
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28