Z-0847-04

Titanium Dual Lumen Implantable Port with PASV Valve and 10F Silicone Catheter. Catalog No/REF: PRTB10A...

Name: Z-0847-04 Titanium Dual Lumen Implantable Port with PASV Valve and 10F Silicone Catheter. Catalog No/REF: PRTB10A...
Creator: Boston Scientific Corporation
Published: 2004-03-29
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2004-03-29 / Terminated

FDA source

Boston Scientific Corporation began a recall of Titanium Dual Lumen Implantable Port with PASV Valve and 10F Silicone Catheter. Catalog No/REF: PRTB10A, Model No. M001PRTB10A. Firm on label: Boston... on 2004-03-29. The reason FDA records is "Catheters may not have adequate radiopacity for proper visualization under fluoroscopy". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0847-04
Status: Terminated
Initiated: 2004-03-29
Posted: 2004-07-20
Terminated: 2005-10-13
Recalling firm: Boston Scientific Corporation
Product: Titanium Dual Lumen Implantable Port with PASV Valve and 10F Silicone Catheter. Catalog No/REF: PRTB10A, Model No. M001PRTB10A. Firm on label: Boston Scientific Corp., NAMIC Technology Center, Glens Falls, NY 12801.
Reason for recall: Catheters may not have adequate radiopacity for proper visualization under fluoroscopy.
FDA root cause: Other
Action: Letters dated 3/29/04 with instruction to remove and return product.
Quantity in commerce: 72 units
Product codes and lots: 916252, 917973

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)