Recalls / —

—#95833

Product

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.

FDA product code

FCG — Biopsy Needle

Device class

Class 2

Medical specialty

Gastroenterology, Urology

510(k) numbers

K100712

Affected lot / code info

Lot/Batch Numbers: 7441839 and 7442099.

Why it was recalled

The firm has received a high number of complaints related to difficulty advancing and/or retracting the needle.

Root cause (FDA determination)

Other

Action the firm took

"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.

Recalling firm

Firm

Boston Scientific Corporation

Address

100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern

Worldwide Distribution -- US and Canada.

Timeline

Recall initiated

2010-10-20

Posted by FDA

2010-12-27

Terminated

2011-08-03

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #95833. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.