Gelsoft Vascular Graft

• 2 recalls, same reason

  • Terminated Z-1912-2015 FDA Class II ·initiated 15 May 2015
  • Terminated Z-1913-2015 FDA Class II ·initiated 15 May 2015

  Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.

Full name

Vascutek Gelsoft(Tm) Vascular Graft

Trade Name

Gelseal Tm Triaxial Vascular Graft

Generic Name

GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE

PMA Number

P890045 ↗

FDA Product Code

MAL

Device Class

Class II

Regulation

21 CFR Part 870.3450

Advisory Committee

Cardiovascular

FDA Decision

APRL

• Minature Pressure Transducer

  Class II

  FDA 510(k) K834040 Active Cleared 10 Feb 1984

• Hydroxylapatite Alveolar Ridge Main

  Class II

  FDA 510(k) K810382 Active Cleared 20 Mar 1981

• Valve Sizer

  Class I

  FDA 510(k) K934951 Active Cleared 10 Dec 1993

• Pyrolite Carbon Alveolar Mainten Implant

  Class II

  FDA 510(k) K791416 Active Cleared 9 Oct 1979

• Carbomedics Supra-Annular Valve Sizer

  Class I

  FDA 510(k) K952184 Active Cleared 29 Nov 1995

• Carbomedics Mitral Rotator

  Class I

  FDA 510(k) K960923 Active Cleared 29 Apr 1996

See all devices from Carbomedics, Inc. →

• What types of cardiovascular procedures is the Gelsoft Vascular Graft intended to support as a replacement or bypass conduit?

  The Gelsoft Vascular Graft is designed specifically for surgical procedures requiring durable vascular support, such as arterial bypasses or replacements in cardiovascular applications. Its synthetic/biologic composite construction makes it suitable for use in contexts where long-term patency and structural integrity are critical, such as coronary, peripheral, or other vascular reconstructions.

• Is the Gelsoft Vascular Graft reusable, or is it meant for single-use only? How should it be stored to maintain sterility?

  The Gelsoft Vascular Graft is explicitly intended for single-use only and is supplied sterile. To preserve sterility, it must be stored under appropriate conditions as specified by the manufacturer, typically in a sealed, sterile packaging until the time of use. Improper storage could compromise its integrity.

• What sizes or configurations are available for the Gelsoft Vascular Graft, and how can I identify them?

  The Gelsoft Vascular Graft is manufactured in multiple sizes and configurations, each corresponding to specific registration numbers (e.g., 2246552, 9612515, 1640201, etc.). These identifiers help distinguish between diameters, lengths, or other variations. The exact sizing details should be referenced in the manufacturer’s documentation or catalog, as they are tailored to different surgical needs.

• How was the regulatory approval process for the Gelsoft Vascular Graft structured, and what does the PMA number indicate?

  The Gelsoft Vascular Graft received FDA Premarket Approval (PMA) under PMA number P890045, which means it underwent a rigorous review process to ensure safety and effectiveness. The PMA was granted after submission to the FDA’s Cardiovascular (CV) Advisory Committee in 1989, with a final decision in 1993. This approval pathway is required for Class II devices like vascular grafts, ensuring compliance with 21 CFR 870.3450.