PRECISE PRO RX Nitinol Stent System

Class III

Model: Multiple lot numbers, Affected: Product manufactured between April 27, 2015 and November 22, 2015.

Yes

Non-active implants - special implants

Medical Device Safety Alert: Cordis Precise Pro RX Nitinol Stent System (Carotid)

Model Catalog: PC1040XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC0740XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC0840XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC0940XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC0640XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC0540XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC0720XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC0820XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC1030XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC0930XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC0830XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC0730XCE (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: PC0630XCE (Lot serial: > 10 NUMBERS CONTACT MFG)

PRECISE PRO RX NITINOL STENT SYSTEM -40MM;PRECISE PRO RX NITINOL STENT SYSTEM - 20MM;PRECISE PRO RX NITINOL STENT SYSTEM - 30MM