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U.S. Department of Health and Human Services

Class 2 Device Recall MICROVASIVE GOLD PROBE

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 Class 2 Device Recall MICROVASIVE GOLD PROBEsee related information
Date Initiated by FirmDecember 24, 2008
Date PostedFebruary 13, 2009
Recall Status1 Terminated 3 on May 11, 2010
Recall NumberZ-0979-2009
Recall Event ID 50697
Product Classification Unit, electrosurgical, endoscopic (with or without accessories) - Product Code KNS
ProductGold Probe 7FR Working Length: 350 cm, Probe Tip O.D. 2.3 mm (7Fr), Rx Only. Electrical Connector: Standard. Single Use Only. Legal Manufacturer, Boston Scientific Corporation, One Boston Scientific Place Natick, MA 01760-1537 USA. Made in USA: 8600 N.W. 41st Street Miami, FL 33166-6202 USA. The device is indicated for use in transendoscopic electrocautery of visible bleeding and nonbleeding sites in the gastrointestinal tract including the esophagus, stomach, duodenum, and colon.
Code Information Lot Numbers for UPN M00560220: 9291645, 9344981, 9394026, 9416584, 9462927, 9501324, 9559362, 9581713, 9636705, 9670186, 9690901, 9741754, 9754809, 9754810, 9754811, 9815965, 9819629, 11006445, 110039853, 11042217, 11129600, 11168985, 11175063, 11234903, 11268506, 11282762, 11327776, 11361680, 11405398, 11445120, 11499437, 11522023, 11540259, 11577720, 11598340, 11647351, 11680236, 11713017, 11751140, 11786708, 11827587, 11850720, 11913776, 11943552, 11961965, 11997177 and 12077478.
FEI Number 1051710
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
8600 Nw 41st St
Miami FL 33166-6202
For Additional Information Contact
305-597-4273
Manufacturer Reason
for Recall		Packaging tray for the Gold Probe Single-Use BiPolar Electrohemostasis Catheters may have a crack. Cracks in the tray or damage to the tray of the Gold Probe device may lead to a compromised sterile barrier.
FDA Determined
Cause 2		Packaging process control
ActionA notification letter (dated December 24, 2008) was issued to customers. The letter identified the issue. Consignees are instructed to: 1) Discontinue use and segregate affected product, 2) Complete a Reply Verification Tracking Form and fax to the Boston Scientific Corporation (BSC) at 508-683-5578 and 3) Package and ship recalled product as instructed in the letter. If affected product is found, customers are instructed to call BSC Customer Service at 1-866-868-4004 between 8:30 a.m. through 6:00 p.m. (Eastern Standard Time). Please direct questions about the recall to your local Sales Representative.
Quantity in Commerce10,841
DistributionWorldwide Distribution.
Total Product Life CycleTPLC Device Report
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.
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