Navigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog M0062502290, Sterile. Indicat

FDA device recall Z-0442-2014 · posted 2013-12-04 · Terminated

Recall details

Recalling firm

Boston Scientific Corporation

Reason for recall

The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator.

Action taken

Urgent recall notification letters were sent via Federal Express Priority mail on November 5, 2013. The notification instructs the account to check their inventory, 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 in their inventory. Follow-up communications will be made to the accounts that do not respond to this inquiry.

Root cause

Component design/selection

Status

Terminated

Product code

FED

Quantity affected

449

Distribution

Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Ireland, Denmark, Italy, France, Canada, Great Britain, Switzerland, South Africa, Germany, and the Nether

Date initiated

2013-11-05

Date posted

2013-12-04

Date terminated

2014-12-08

Location

Marlborough, MA