Z-0811-2011

Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, 22GA (0.72 mm) sterile, UPN M00550011, 5...

Name: Z-0811-2011 Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, 22GA (0.72 mm) sterile, UPN M00550011, 5...
Creator: Boston Scientific Corporation
Published: 2010-10-20
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2010-10-20 / Terminated

FDA source

Boston Scientific Corporation began a recall of Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, 22GA (0.72 mm) sterile, UPN M00550011, 5 pack, 428 Technology Drive East, Menomonie, WI... on 2010-10-20. The reason FDA records is "The firm has received a high number of complaints related to difficulty advancing and/or retracting the needle". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0811-2011
Status: Terminated
Initiated: 2010-10-20
Posted: 2010-12-27
Terminated: 2011-08-03
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, 22GA (0.72 mm) sterile, UPN M00550011, 5 pack, 428 Technology Drive East, Menomonie, WI. Designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
Product code: FCG Biopsy Needle
Reason for recall: The firm has received a high number of complaints related to difficulty advancing and/or retracting the needle.
FDA root cause: 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 commerce: 567 all products.
Distribution: Worldwide Distribution -- US and Canada.
Product codes and lots: Lot/Batch Numbers: 7860533 and 7983132.

Product code FCG

K100712Class IIResound Endoscopic Ultrasound Aspiration NeedleBoston Scientific Corporation / cleared 2010-03-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)