FDA Medical Device Recalls (openFDA)
Medtronic, Inc.: Medtronic SiteSeer 5 F Tight Radius 145 Pigtail Cardiovascular Angiographic Catheter Item Number: 5A0029
- Recall number
- Z-0523-04
- Recalling firm
- Medtronic, Inc.
- Product
- Medtronic SiteSeer 5 F Tight Radius 145 Pigtail Cardiovascular Angiographic Catheter Item Number: 5A0029
- Status
- Terminated
- Initiated
- 2004-01-14
- Posted
- 2004-02-10
- Terminated
- 2004-11-15
- Reason
- Catheter distal tip may separate
- Root cause
- Other
- Action
- Medtronic notified sales representatives/distributors on 1/14/04 via telephone and email and requested to retrieve affected product from the hospitals and return it to Danvers, MA. A script and effectiveness document was provided and to be reviewed with the hospital.
- Quantity
- 20 units
- Distribution
- NC, WA
- Lot, serial or model codes
- Lot Number: 160760 Expiration Date: 2006-12
- 510(k) numbers
- ["K932092"]
- PMA numbers
- not on file
- Product code
- DQO
- Firm FEI
- 1220452
- Firm city
- Danvers
- Firm state
- MA
- 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