Boston 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.
FDA Recall Z-0809-2011 · Posted 2010-12-27
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Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeFCG
Date Initiated2010-10-20
Date Terminated2011-08-03
Product Quantity567 all products
Reason for Recall
The firm has received a high number of complaints related to difficulty advancing and/or retracting the needle.
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide Distribution -- US and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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