FDA Medical Device Recalls (openFDA)
Boston Scientific Corp: NAMIC Custom Angiographic Kit, Left Heart Kit. - . Model #: H7496019054110. Catalog #601905411. Firm on kit label: Manufactured by: Boston Scientific Corporation/NAMIC Technology Center, Glens Falls, NY 12801.
- Recall number
- Z-0303-05
- Recalling firm
- Boston Scientific Corp
- Product
- NAMIC Custom Angiographic Kit, Left Heart Kit. - . Model #: H7496019054110. Catalog #601905411. Firm on kit label: Manufactured by: Boston Scientific Corporation/NAMIC Technology Center, Glens Falls, NY 12801.
- Status
- Terminated
- Initiated
- 2004-10-21
- Posted
- 2004-12-09
- Terminated
- 2005-10-13
- Reason
- The kits contains defective Magellan Monoject Safety Needles. The needle shaft may separate from the hub. Tyco Healthcare has recalled the needles.
- Root cause
- Other
- Action
- Two customers contacted via phone on 10/21/04 and 10/22/04, followed by letters dated 11/17/2004. Customers instructed to discontinue use and return product. Distributor instructed to notify customers.
- Quantity
- 24 kits
- Distribution
- 2 customers in IL and NV.
- Lot, serial or model codes
- 988046
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FMI
- Firm FEI
- 3017892510
- Firm city
- Glens Falls
- Firm state
- NY
- 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