FDA Medical Device Recalls (openFDA)
Boston Scientific Scimed: Boston Scientific Scimed Express 2 Monorail 2.5 mm 12mm Coronary Stent System, Catalog Number H7493505012250
- Recall number
- Z-0711-03
- Recalling firm
- Boston Scientific Scimed
- Product
- Boston Scientific Scimed Express 2 Monorail 2.5 mm 12mm Coronary Stent System, Catalog Number H7493505012250
- Status
- Terminated
- Initiated
- 2003-03-20
- Posted
- 2003-04-09
- Terminated
- 2004-07-02
- Reason
- The product units in the recalled lot were in pouches which could have incomplete seals that could lead to compromised sterility.
- Root cause
- Other
- Action
- Consignees were sent a recall letter dated March 20, 2003. The letter requested that the consignees discontinue use of stents from the affected lot and return them.
- Quantity
- 31 stents
- Distribution
- The product was shipped to 18 hospitals located nationwide in the United States. There are no US Government or foreign accounts.
- Lot, serial or model codes
- Lot number 5140999
- 510(k) numbers
- not on file
- PMA numbers
- ["P020009"]
- 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