Z-1488-05

Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/19/Plastic Catalog Number : 45-541

Name: Z-1488-05 Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/19/Plastic Catalog Number : 45-541
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 Plus Chronic Dialysis Catheters - Catheter/CPU/15/19/Plastic Catalog Number : 45-541 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-1488-05
Status: Terminated
Initiated: 2005-07-22
Posted: 2005-09-02
Terminated: 2007-06-20
Recalling firm: Boston Scientific Corporation
Product: Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/19/Plastic Catalog Number : 45-541
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: 973523 974713 993812 993813 1000935 1000936 1000937 1000938 1000939 1002367 1009153 1018969 1018970 1018971 1027107 1027108 1027109 1027110 1027111 1028098

Product code KOB

K032712Class IIVaxcel Plus Chronic Dialysis CatheterBoston Scientific Corp / cleared 2003-10-02

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)