FDA Medical Device Recalls (openFDA)
Bard Peripheral Vascular Inc: Opti-Plast Balloon Dilatation Catheters
- Recall number
- Z-0002-04
- Recalling firm
- Bard Peripheral Vascular Inc
- Product
- Opti-Plast Balloon Dilatation Catheters
- Status
- Terminated
- Initiated
- 2003-08-20
- Posted
- 2003-10-15
- Terminated
- 2005-11-21
- Reason
- Product intended for distribution outside USA was distributed without premarket notification requirements being met.
- Root cause
- Other
- Action
- The firm notified territory managers by telephone on August 20, 2003 to hold all consigned devices for return.
- Quantity
- 14 units
- Distribution
- OH, AL, MS, LA, VA
- Lot, serial or model codes
- Models: XT75410, XT100410, XT120410
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GBR
- Firm FEI
- 2020394
- Firm city
- Tempe
- Firm state
- AZ
- 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