Z-1484-05

Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Standard/PS/PU/8/1.6/2.6/63 Catalog...

Name: Z-1484-05 Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Standard/PS/PU/8/1.6/2.6/63 Catalog...
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 Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Standard/PS/PU/8/1.6/2.6/63 Catalog Number : 45-356 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-1484-05
Status: Terminated
Initiated: 2005-07-22
Posted: 2005-09-02
Terminated: 2007-06-20
Recalling firm: Boston Scientific Corporation
Product: Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Standard/PS/PU/8/1.6/2.6/63 Catalog Number : 45-356
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 Numbers: 916200 921356 945848 958513 962137 970277 979019 979836 987578 1001739 1002354 1003620 1006322 962137D

Product code KOB

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)