Recalls / —

—#40589

Product

Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Mini/T/PU/8/1.6/2.6/63 Catalog Number : 45-220

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: 919480 924195 924850 929107  932116 936291 938095 940273 943742 945847 946253 958508  958814 959674 968282 969954 971538 973971 977485 979329  985139 986238 1001735 1001736 1001737 1003619 1004053 1007397 959674D 969954D

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 #40589. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.