FDA Medical Device Recalls (openFDA)
Boston Scientific Corp: ''NAMIC Custom Angiographic Kit'' sold under the following labels: (1) Medical University of South Carolina. Pouch Catalog # 60131481; (2) Covenant Medical Center, Pouch Catalog #60131603; (3) St. Joseph Hospital, Pouch Catalog #60101041; (4) Spectrum Health, Pouch Catalog #61020031 (5) Rush Foundation Hospital, Kit #65185472 ****** Responsible firm on product labels: Boston Scientific/SCIMED *** Manufactured by: Boston Scientific Corporation / NAMIC Technology Center / Glens Falls, New York 12801. ****** Each kit is customized to the needs of the particular hospital identified on the product labeling.
- Recall number
- Z-1393-05
- Recalling firm
- Boston Scientific Corp
- Product
- ''NAMIC Custom Angiographic Kit'' sold under the following labels: (1) Medical University of South Carolina. Pouch Catalog # 60131481; (2) Covenant Medical Center, Pouch Catalog #60131603; (3) St. Joseph Hospital, Pouch Catalog #60101041; (4) Spectrum Health, Pouch Catalog #61020031 (5) Rush Foundation Hospital, Kit #65185472 ****** Responsible firm on product labels: Boston Scientific/SCIMED *** Manufactured by: Boston Scientific Corporation / NAMIC Technology Center / Glens Falls, New York 12801. ****** Each kit is customized to the needs of the particular hospital identified on the product labeling.
- Status
- Terminated
- Initiated
- 2004-05-05
- Posted
- 2005-08-24
- Terminated
- 2005-08-31
- Reason
- Molded handles used in Angiographic Manifolds may be occluded.
- Root cause
- Other
- Action
- Letters dated 5/4/2004 to Risk Managers with instructions to return product.
- Quantity
- 1115 kits
- Distribution
- The kits were custom made and sold to consignees in IL, KY, MI, SC, and TX.
- Lot, serial or model codes
- (1) Medical University of SC label: Lot 942414 (2) Covenant label: Lot 939982, 943645; (3) St. Joseph label: Lot 940424; (4) Spectrum label: Lot 940054 (5) Rush Foundation label: Lot 945456; 943043
- 510(k) numbers
- ["K782095"]
- PMA numbers
- not on file
- Product code
- DTZ
- 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