FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Boston Scientific Scimed Maverick 2 Monorail" PTCA Catheter, 3.0 mm 15 mm REF 38928-1530 Lot 9565194 Use before 2010-04 Indicated for balloon dilation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
- Recall number
- Z-2165-2008
- Recalling firm
- Boston Scientific Corporation
- Product
- Boston Scientific Scimed Maverick 2 Monorail" PTCA Catheter, 3.0 mm 15 mm REF 38928-1530 Lot 9565194 Use before 2010-04 Indicated for balloon dilation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
- Status
- Terminated
- Initiated
- 2007-05-01
- Posted
- 2008-08-26
- Terminated
- 2008-09-10
- Reason
- The units within this lot may not meet thickness specifications surrounding the wire exit port wall, which may result in an air embolization if the Port Septum Wall burts.
- Root cause
- Nonconforming Material/Component
- Action
- Consignees were sent a "Boston Scientific Urgent Medical Device Recall or Correction-Immediate Action Required" letter dated May 11, 2007. The letter addressed to Risk mangers, described the issue and product. The letter requested the immediate discontinued use of and segregation of recalled product, A Reply Verification Tracking Form was requested to be completed and returned.
- Quantity
- 24 Units
- Distribution
- International Distribution --- including countries of Greece, Germany, Great Britain, Spain, Sweden, Belgium, and Algeria.
- Lot, serial or model codes
- Lot 9565194, Exp April 2010.
- 510(k) numbers
- not on file
- PMA numbers
- ["P860019"]
- Product code
- LOX
- Firm FEI
- 3001451463
- Firm city
- Natick
- Firm state
- MA
- 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