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U.S. Department of Health and Human Services

Class 2 Device Recall Expect Endoscopic Ultrasound Aspiration Needle

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 Class 2 Device Recall Expect Endoscopic Ultrasound Aspiration Needlesee related information
Date Initiated by FirmOctober 20, 2010
Date PostedDecember 27, 2010
Recall Status1 Terminated 3 on August 03, 2011
Recall NumberZ-0809-2011
Recall Event ID 57317
510(K)NumberK100712 
Product Classification Biopsy Needle Kit - Product Code FCG
ProductBoston Scientific Expect Endoscopic Ultrasound Aspiration Needle, Single Pack, 22GA (0.72 mm) sterile, UPN M00550010, 428 Technology Drive East, Menomonie, WI. Designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
Code Information Lot/Batch Numbers: 7860533, 7982702 and 7983132.
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information ContactCindy Finney
508-683-8000
Manufacturer Reason
for Recall		The firm has received a high number of complaints related to difficulty advancing and/or retracting the needle.
FDA Determined
Cause 2		Other
Action"Urgent Medical Device Recall - Immediate Action Required" notification letters were sent via Federal Express Priority mail on October 20, 2010. The letters identified the affected product and stated the reason for the recall. The notification instructs the account to immediately discontinue use of, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory.
Quantity in Commerce567 all products
DistributionWorldwide Distribution -- US and Canada.
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.
510(K) Database510(K)s with Product Code = FCG
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