Recall Z-0812-2011 ยท FCG Biopsy Needle
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.
| Date | Dec 27, 2010 (initiated Oct 20, 2010) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100712 | RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE Boston Scientific Corporation, Mar 30, 2010 |