33 results · 18ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic introduction of the patch into the operating environment. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the patch matrix. Finally, the patch is transferred for long-term storage at or below 135 C. CryoPatch SG is distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk and pulmonary branch.

FDA Recall
Terminated ·CryoLife, Inc.·Product code DXZ·November 10, 2020

Vascu Guard, Peripheral Vascular Patch with Apex Processing. For use in peripheral vascular reconstruction. Product Code: VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0108N VG0110N VG0110N VG0110N VG0110N VG0110N VG0110N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N VG0209N

FDA Recall
Terminated ·Synovis Surgical Innovations, Inc.·Product code DXZ·October 28, 2013

Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code 1504026, 0.8x8cm, product code 1504028, 1x10cm, product code 1504030, and 2x9cm, product code 1504032. VASCU-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile. VASCU-GUARD is intended for use in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.

FDA Recall
Terminated ·Synovis Surgical Innovations, Inc.·Product code DXZ·May 2, 2015

(1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology; and (2) CryoPatch SG Pulmonary Human Cardiac Branch Patch, SGP020, Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology.

FDA Recall
Open, Classified ·Artivion, Inc·Product code DXZ·May 28, 2024

CryoPatch SG Pulmonary Hemi-Artery Patch

FDA Recall
Terminated ·CryoLife, Inc.·Product code DXZ·November 21, 2016

Pulmonary Hemi-Artery SG Used in heart surgery

FDA Recall
Terminated ·CryoLife, Inc.·Product code DXZ·November 22, 2013

Pulmonary Hemi-Artery SG Used in heart surgery

FDA Recall
Terminated ·CryoLife, Inc.·Product code DXZ·February 17, 2011

Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, product code VG0108N, 1 cm x 10 cm, product code VG0110N, and 2 cm x 9 cm, product code VG0209N. VASC U-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. Sterilized using aseptic processing techniques. The pericardium is procured from cattle originating in the United States. VASC-Guard is chemically sterilized using ethanol and propylene oxide. UPDATE 9/1/2016 Retrieval of devices only includes Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, product code VG0108N.

FDA Recall
Terminated ·Baxter Healthcare Corp.·Product code DXZ·June 24, 2016

HEMASHIELD Knitted Double Velour Cardiovascular Fabric

FDA Recall
Terminated ·GETINGE US SALES LLC·Product code DXZ·January 3, 2018

SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

FDA Recall
Open, Classified ·Glycar SA Pty., Ltd.·Product code DXZ·October 9, 2025

Vascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes: a) VG0108N: 0.8X8 CM GLOBAL, b) VG0110N: 1X10 CM GLOBAL, c) VG0106N: 1X6 CM GLOBAL, d) VG0209N: 2X9 CM GLOBAL

FDA Recall
Open, Classified ·Baxter Healthcare Corporation·Product code DXZ·December 6, 2023

PSD Gel that's provided with Peri-Strips Dry Staple Line Reinforcement with Apex Processing (PSD) and Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V) products. Sterile, Rx only, Synovis Surgical Innovations. Intended to be used as a staple line buttress.

FDA Recall
Terminated ·Synovis Surgical Inovation Div. of·Product code DXZ·June 30, 2010

PTFE (Polytetrafluoroethylene) felt. Catalog #s: M002000193041, M002000193061, M002000193811, M002000193821, M002000193931, M002000193841, M002000193861, M002000193881.

FDA Recall
Terminated ·Boston Scientific Scimed·Product code DXZ·April 19, 2005

Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020

FDA Recall
Terminated ·CryoLife, Inc.·Product code DXZ·May 14, 2018

Pulmonary Valve & Conduit SG Used in heart surgery

FDA Recall
Terminated ·CryoLife, Inc.·Product code DXZ·February 17, 2011

Hemashield Double Velour Cardiovascular Fabrics.

FDA Recall
Terminated ·Maquet Cardiovascular, LLC·Product code DXZ·May 24, 2010

CryoPatch SG Pulmonary Hemi-Artery, 1 graft

FDA Recall
Terminated ·CryoLife, Inc.·Product code DXZ·September 6, 2018

PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG0404: 4 X 4 CM US, TS; c) SPG0608: 6 X 8 CM US, TS; d) SPG0814: 8 X 14 CM US, TS; e) PC1016SNBIO: 10X16 CM US; f) PC0404SNBIO: 4X4 CM US; g) PC0608SNBIO: 6X8 CM US; h) PC0814SNBIO: 8X14 CM US

FDA Recall
Open, Classified ·Baxter Healthcare Corporation·Product code DXZ·December 6, 2023

The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t

FDA Recall
Terminated ·Vascutek, Ltd. Newmains Avenue Inchinnan United Kingdom·Product code DXZ·July 8, 2021

SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

FDA Recall
Open, Classified ·Glycar SA Pty., Ltd.·Product code DXZ·October 9, 2025