FDA Medical Device Recalls (openFDA)
Boston Scientific Scimed: Boston Scientific Scimed Radius 3.0 mm x 31 mm Self-Expanding Coronary Stent with Over-the-Wire Delivery System, Catalog Number H74917500301
- Recall number
- Z-0777-03
- Recalling firm
- Boston Scientific Scimed
- Product
- Boston Scientific Scimed Radius 3.0 mm x 31 mm Self-Expanding Coronary Stent with Over-the-Wire Delivery System, Catalog Number H74917500301
- Status
- Terminated
- Initiated
- 2003-03-17
- Posted
- 2003-04-22
- Terminated
- 2004-07-02
- Reason
- A component within the manifold of the stent delivery systems was found to have pyrogen levels above specification.
- Root cause
- Other
- Action
- Consignees were sent a recall letter dated March 17, 2003. The letter requested that consignees discontinue use of stents from the affected lots and return them.
- Quantity
- 4 Stent Systems
- Distribution
- Nationwide in the United States
- Lot, serial or model codes
- Lot number 5357125
- 510(k) numbers
- not on file
- PMA numbers
- ["P970061"]
- Product code
- MAF
- Firm FEI
- 3002095335
- Firm city
- Maple Grove
- Firm state
- MN
- 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