Z-0697-2007

Boston Scientific SpyGlass Ocular Reference Number: 4604 UPN M00546040

Name: Z-0697-2007 Boston Scientific SpyGlass Ocular Reference Number: 4604 UPN M00546040
Creator: Boston Scientific Corporation
Published: 2007-02-07
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2007-02-07 / Terminated

FDA source

Boston Scientific Corporation began a recall of Boston Scientific SpyGlass Ocular Reference Number: 4604 UPN M00546040 on 2007-02-07. The reason FDA records is "SpyGlass Probe and Ocular: Ocular is out of specification and during disconnect may damage probe". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0697-2007
Status: Terminated
Initiated: 2007-02-07
Posted: 2007-03-31
Terminated: 2007-11-15
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific SpyGlass Ocular Reference Number: 4604 UPN M00546040
Product code: KOG
Reason for recall: SpyGlass Probe and Ocular: Ocular is out of specification and during disconnect may damage probe
FDA root cause: Other
Action: Boston Scientific notified accounts by letter dated 2/1/07 requesting return of product.
Quantity in commerce: 12 units
Distribution: Nationwide Distribution --- including states of CA, CO, FL, OH, MA, MN, MO NY, PA, SC,TX, and WA .
Product codes and lots: Lot Number: 532202

Product code KOG

K052194Class IISpyglass Direct Visualization Probe and OcularBoston Scientific Corp / cleared 2005-08-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)