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Terminated

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.

FDA Recall Z-0847-04 · Posted 2004-07-20

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Date Initiated2004-03-29
Date Terminated2005-10-13
Product Quantity72 units

Reason for Recall

Catheters may not have adequate radiopacity for proper visualization under fluoroscopy.

Firm Action

Letters dated 3/29/04 with instruction to remove and return product.

Root Cause

Other

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K991897CATHETER INNOVATIONS IMPLANTABLE PORTCatheter Innovations, Inc. · 1999-10-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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