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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific Boston Scientific SpyGlass Ocular

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 Class 2 Device Recall Boston Scientific Boston Scientific SpyGlass Ocularsee related information
Date Initiated by FirmFebruary 07, 2007
Date PostedMarch 31, 2007
Recall Status1 Terminated 3 on November 15, 2007
Recall NumberZ-0697-2007
Recall Event ID 37403
510(K)NumberK052194 
Product Classification Ocular - Product Code KOG
ProductBoston Scientific SpyGlass Ocular Reference Number: 4604 UPN M00546040
Code Information Lot Number: 532202
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Boston Scientific Pl
Natick MA 01760-1536
For Additional Information ContactDebra Prout
508-683-4433
Manufacturer Reason
for Recall		SpyGlass Probe and Ocular: Ocular is out of specification and during disconnect may damage probe
FDA Determined
Cause 2		Other
ActionBoston Scientific notified accounts by letter dated 2/1/07 requesting return of product.
Quantity in Commerce12 units
DistributionNationwide Distribution --- including states of CA, CO, FL, OH, MA, MN, MO NY, PA, SC,TX, and WA .
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KOG
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