FDA Medical Device Recalls (openFDA)
Medtronic Vascular: Pioneer Catheter (Crosspoint TransAccess Catheter); Model TA-XP-001; Product is manufactured and distributed by Medtronic Vascular, Santa Rosa, CA 95403
- Recall number
- Z-0208-2007
- Recalling firm
- Medtronic Vascular
- Product
- Pioneer Catheter (Crosspoint TransAccess Catheter); Model TA-XP-001; Product is manufactured and distributed by Medtronic Vascular, Santa Rosa, CA 95403
- Status
- Terminated
- Initiated
- 2006-11-01
- Posted
- 2006-11-22
- Terminated
- 2007-12-05
- Reason
- Sterility may be compromised as evidenced by a loss of package integrity.
- Root cause
- Other
- Action
- On 11/1/06, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall.
- Quantity
- 502
- Distribution
- Worldwide, including USA, Switzerland, France, Belgium, Germany.
- Lot, serial or model codes
- All Codes.
- 510(k) numbers
- ["K031920"]
- PMA numbers
- not on file
- Product code
- ITX
- Firm FEI
- 3003311129
- Firm city
- Santa Rosa
- Firm state
- CA
- 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