Recalls / —

—#50490

Product

Boston Scientific SpyGlass Visualization Probe Reference Number: 4603 UPN M00546030

FDA product code

KOG

510(k) numbers

K052194

Affected lot / code info

Lot number: 527301, 527302, 533202, 625401, 628902, 630001, 633201, 635501, 702901

Why it was recalled

SpyGlass Probe and Ocular: Ocular is out of specification and during disconnect may damage probe

Root cause (FDA determination)

Other

Action the firm took

Boston Scientific notified accounts by letter dated 2/1/07 requesting return of product.

Recalling firm

Firm

Boston Scientific Corporation

Address

1 Boston Scientific Pl, Natick, Massachusetts 01760-1536

Distribution

Distribution pattern

Nationwide Distribution --- including states of CA, CO, FL, OH, MA, MN, MO NY, PA, SC,TX, and WA .

Timeline

Recall initiated

2007-02-07

Posted by FDA

2007-03-31

Terminated

2007-11-15

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #50490. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.