Z-1511-05

Tunneled Central Venous Catheters With PASV Valve Technology And Polyester Cuff - PASV CVC/SL/9.6/IK Catalog...

Name: Z-1511-05 Tunneled Central Venous Catheters With PASV Valve Technology And Polyester Cuff - PASV CVC/SL/9.6/IK 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 Tunneled Central Venous Catheters With PASV Valve Technology And Polyester Cuff - PASV CVC/SL/9.6/IK Catalog Number: CVC961IK 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-1511-05
Status: Terminated
Initiated: 2005-07-22
Posted: 2005-09-02
Terminated: 2007-06-20
Recalling firm: Boston Scientific Corporation
Product: Tunneled Central Venous Catheters With PASV Valve Technology And Polyester Cuff - PASV CVC/SL/9.6/IK Catalog Number: CVC961IK
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: 970797 975780 976519 984496 991184 1012876 1014484 1015393 1017361 1018981 1019389 1019740 1025515 1028107 1029092

Product code KOB

K962300Class IIClampless Valved CatheterBmw Medical, Inc. / cleared 1996-09-05

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)