FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, 25GA (0.52 mm) sterile, UPN M00550021, 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.
- Recall number
- Z-0812-2011
- Recalling firm
- Boston Scientific Corporation
- Product
- Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, 25GA (0.52 mm) sterile, UPN M00550021, 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.
- Status
- Terminated
- Initiated
- 2010-10-20
- Posted
- 2010-12-27
- Terminated
- 2011-08-03
- Reason
- The firm has received a high number of complaints related to difficulty advancing and/or retracting the needle.
- 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
- 567 all products
- Distribution
- Worldwide Distribution -- US and Canada.
- Lot, serial or model codes
- Lot/Batch Number: 7442099.
- 510(k) numbers
- ["K100712"]
- PMA numbers
- not on file
- Product code
- FCG
- Firm FEI
- 3005099803
- Firm city
- Marlborough
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28