Z-1515-05

Implantable Chest Ports With PASV Valve Technology - Single Lumen - PASV Port/9.6/SL/T/PA Catalog Number...

Name: Z-1515-05 Implantable Chest Ports With PASV Valve Technology - Single Lumen - PASV Port/9.6/SL/T/PA Catalog Number...
Creator: Boston Scientific Corporation
Published: 2005-07-22
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2005-07-22 / Terminated

FDA source

Boston Scientific Corporation began a recall of Implantable Chest Ports With PASV Valve Technology - Single Lumen - PASV Port/9.6/SL/T/PA Catalog Number: PRTA96P on 2005-07-22. The reason FDA records is "The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1515-05
Status: Terminated
Initiated: 2005-07-22
Posted: 2005-09-02
Terminated: 2007-06-20
Recalling firm: Boston Scientific Corporation
Product: Implantable Chest Ports With PASV Valve Technology - Single Lumen - PASV Port/9.6/SL/T/PA Catalog Number: PRTA96P
Product code: KOB Catheter, Suprapubic (And Accessories)
Reason for recall: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
FDA root cause: Other
Action: 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.
Distribution: Nationwide VA Hopsitals Foreign: Canada, Africa, Japan, Israel, Japan, Nertherlands, Venezula
Product codes and lots: Lot Number: 966434 971099 973185 985889 992209 993834 1000971 1001770 1004074 1008239 1009178 1020905 1020906 1020907 1022959 1029930

Product code KOB

K991897Class IICatheter Innovations Implantable PortCatheter Innovations, Inc. / cleared 1999-10-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)