Z-0303-05

NAMIC Custom Angiographic Kit, Left Heart Kit. - . Model #: H7496019054110. Catalog #601905411. Firm on kit...

Name: Z-0303-05 NAMIC Custom Angiographic Kit, Left Heart Kit. - . Model #: H7496019054110. Catalog #601905411. Firm on kit...
Creator: Boston Scientific Corp
Published: 2004-10-21
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2004-10-21 / Terminated

FDA source

Boston Scientific Corp began a recall of NAMIC Custom Angiographic Kit, Left Heart Kit. - . Model #: H7496019054110. Catalog #601905411. Firm on kit label: Manufactured by: Boston Scientific... on 2004-10-21. The reason FDA records is "The kits contains defective Magellan Monoject Safety Needles. The needle shaft may separate from the hub. Tyco Healthcare has recalled the needles". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0303-05
Status: Terminated
Initiated: 2004-10-21
Posted: 2004-12-09
Terminated: 2005-10-13
Recalling firm: Boston Scientific Corporation
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.
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: The kits contains defective Magellan Monoject Safety Needles. The needle shaft may separate from the hub. Tyco Healthcare has recalled the needles.
FDA 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 in commerce: 24 kits
Distribution: 2 customers in IL and NV.
Product codes and lots: 988046

Product code FMI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)