Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, Single Pack, 25GA (0.52 mm) sterile, UPN M00550020, 428 Technology Drive East, Menomonie, WI. Designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.
This recall has been terminated (originally issued December 27, 2010).
- Company
- Boston Scientific Corporation
- Recall Initiated
- October 20, 2010
- Posted
- December 27, 2010
- Terminated
- August 3, 2011
- Recall Number
- Z-0810-2011
- Quantity
- 567 all products
- Firm Location
- Marlborough, MA
- Official Source
- View on FDA website ↗
Reason for Recall
The firm has received a high number of complaints related to difficulty advancing and/or retracting the needle.
Distribution
Worldwide Distribution -- US and Canada.
Lot / Code Info
Lot/Batch Numbers: 7441839 and 7442099.
Root Cause
Other
Action Taken
"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.