# K030083: Vaxcel with Pasv Port

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Jan 28, 2003 after 19 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: 21 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) VaxcelTM Implantable port system: named in the summary without a submission number
- (no number) PASVB implantable port system: named in the summary without a submission number
- (no number) VaxcelTM with PASVB PICC: named in the summary without a submission number

## Most influential descendants
- K031844: Vaxcel with Pasv Port (Low Profile), Models 45-236 and 45-238 (2003), 6 descendants of its own
- K032375: Vaxcel Port, Models 45-336 and 45-338 (2003), 5 descendants of its own
- K032600: Vaxcel Port, Model 45-333 and Vaxcel W/Pasv Port, Model 45-233 (2003), 4 descendants of its own
- K122767: Nmi Port (2013), 3 descendants of its own
- K131694: Nmi Port II Catheter (2013), 2 descendants of its own

## Recalls of this device
- May 13, 2010 · Not classified · Z-1876-2010: FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
- May 13, 2010 · Not classified · Z-1880-2010: FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
- May 13, 2010 · Not classified · Z-1879-2010: FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
- May 13, 2010 · Not classified · Z-1878-2010: FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
- May 13, 2010 · Not classified · Z-1874-2010: FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
- May 13, 2010 · Not classified · Z-1877-2010: FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
- May 13, 2010 · Not classified · Z-1875-2010: FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
- Sep 27, 2006 · Not classified · Z-0630-2007: Sterile barrier may have been compromised. Firm received one complaint which demonstrated that the inner and outer seals of the port tray packaging had been compromised.
- Sep 27, 2006 · Not classified · Z-0631-2007: Sterile barrier may have been compromised. Firm received one complaint which demonstrated that the inner and outer seals of the port tray packaging had been compromised.
- Jul 22, 2005 · Not classified · Z-1485-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Jul 22, 2005 · Not classified · Z-1480-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Jul 22, 2005 · Not classified · Z-1474-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Jul 22, 2005 · Not classified · Z-1477-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Jul 22, 2005 · Not classified · Z-1475-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Jul 22, 2005 · Not classified · Z-1483-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Jul 22, 2005 · Not classified · Z-1473-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Jul 22, 2005 · Not classified · Z-1482-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Jul 22, 2005 · Not classified · Z-1478-05: The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Feb 10, 2004 · Not classified · Z-0732-04: Reports of catheter separation/fracture after implantation resulting in distal migration of the catheter.
- Feb 10, 2004 · Not classified · Z-0731-04: Reports of catheter separation/fracture after implantation resulting in distal migration of the catheter.
- Feb 10, 2004 · Not classified · Z-0734-04: Reports of catheter separation/fracture after implantation resulting in distal migration of the catheter.

## Indications for use
The VaxcelTMw/ PASVB Port device is intended for use in patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. The device is also indicated for blood specimen withdrawal.

Source page: https://510kreport.com/device/K030083
Methodology: https://510kreport.com/methodology