FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Boston Scientific SpyGlass Visualization Probe Reference Number: 4603 UPN M00546030
- Recall number
- Z-0696-2007
- Recalling firm
- Boston Scientific Corporation
- Product
- Boston Scientific SpyGlass Visualization Probe Reference Number: 4603 UPN M00546030
- Status
- Terminated
- Initiated
- 2007-02-07
- Posted
- 2007-03-31
- Terminated
- 2007-11-15
- Reason
- SpyGlass Probe and Ocular: Ocular is out of specification and during disconnect may damage probe
- Root cause
- Other
- Action
- Boston Scientific notified accounts by letter dated 2/1/07 requesting return of product.
- Quantity
- 115 units
- Distribution
- Nationwide Distribution --- including states of CA, CO, FL, OH, MA, MN, MO NY, PA, SC,TX, and WA .
- Lot, serial or model codes
- Lot number: 527301, 527302, 533202, 625401, 628902, 630001, 633201, 635501, 702901
- 510(k) numbers
- ["K052194"]
- PMA numbers
- not on file
- Product code
- KOG
- 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