—#40588

Product

Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Mini/T/PU/8/1.6/2.6/63 Catalog Number : 45-215

FDA product code: KOB — Catheter, Suprapubic (And Accessories)
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K030083
Affected lot / code info: Lot Numbers: 904298 907475 916189 916193 916670 916671 917024 919478 919479 919973 920314 920761 922593 922982 924194 924849 926889 927902 927903 928721 931395 932992 933282 933688 937477 939043 939459 939785 940272 940576 943741 944476 944968 958507 968281 968733 969953 970275 973166 973517 974967 979015 979016 979610 985138 986235 986236 986237 1001730 1001731 1001732 1001733 1001734 1002346 1002347 1002348 1002349 1002766 1004052 958507D 968281D 968733D

Why it was recalled

The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

Root cause (FDA determination)

Other

Action the firm took

Boston Scientific intiated the recall on 7/22/05 to direct accounts and to distributors on 7/ 27 /05. Distributors are requested to conduct sub recalls to the medical facility level. A revised letter dated 8/2/05 was sent to 18 US accounts for one lot (#1020895) omitted in the letter of 7/22/05.

Recalling firm

Firm: Boston Scientific Corporation
Address: 1 Boston Scientific Pl, Natick, Massachusetts 01760-1536

Distribution

Distribution pattern: Nationwide VA Hopsitals Foreign: Canada, Africa, Japan, Israel, Japan, Nertherlands, Venezula

Timeline

Recall initiated: 2005-07-22
Posted by FDA: 2005-09-02
Terminated: 2007-06-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #40588. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.