Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
FDA product code DXZ · Class II (moderate risk) · 21 CFR 870.3470 · Cardiovascular
90510(k) clearances
0PMA approvals
19recalls
Implantimplanted device
Manufacturers
- W. L. Gore & Associates, Inc. 13
- Chase Medical, Inc. 7
- Cormatrix Cardiovascular, Inc. 5
- Meadox Medicals, Div. Boston Scientific Corp. 5
- Bio-Vascular, Inc. 4
- ETHICON, Inc. 3
- CryoLife, Inc. 3
- Somanetics Corp. 3
- Shelhigh, Inc. 3
- Intervascular, Inc. 2
- Atrium Medical Corporation 2
- Sulzer Carbomedics, Inc. 2
- Bridger Biomed, Inc. 2
- Glycar, Inc. 2
- Vascutek, Ltd. 2
- Davis & Geck, Inc. 2
- Synovis Surgical Innovations 2
- Extracorporeal Medical Specialities, Inc. 2
- Genetic Laboratories, Inc. 2
- Shiley, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240775 | PeriBeam® Pericardial MembraneDXZ · Traditional | Tamabio | 04/18/2025SE |
| K200955 | Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid PatchDXZ · Traditional | Vascutek, Ltd. | 07/08/2020SE |
| K162506 | PhotoFix Decellularized Bovine PericardiumDXZ · Traditional | Cryolife, Inc. | 03/09/2017SE |
| K162579 | VascuCelDXZ · Special | Admedus Regen Pty, Ltd. | 10/14/2016SE |
| K152127 | CorMatrix TykeDXZ · Traditional | Cormatrix Cardiovascular, Inc. | 02/04/2016SE |
| K151865 | PremiPatch PTFE PledgetDXZ · Traditional | Aesculap, Inc. | 10/27/2015SE |
| K142447 | PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair PatchDXZ · Traditional | Synovis Life Technologies, Inc. | 01/07/2015SE |
| K142461 | VASCU-GUARD Peripheral Vascular PatchDXZ · Traditional | Synovis Life Technologies, Inc. | 11/25/2014SE |
| K140789 | Cormatrix Ecm for Vascular RepairDXZ · Traditional | Cormatrix Cardiovascular, Inc. | 07/15/2014SE |
| K130872 | CardiocelDXZ · Traditional | Celxcel Pty, Ltd. | 01/30/2014SE |
| K122306 | Synovis Collagen Matrix (TBD)DXZ · Traditional | Synovis Surgical Innovations | 03/08/2013SE |
| K122105 | Smi Cardiovascular PatchDXZ · Special | Solinas Medical, Inc. | 12/07/2012SE |
| K112683 | Smi Cardiovascular PachDXZ · Traditional | Solimas Medical, Inc. | 12/14/2011SE |
| K111187 | Patch, Pledget and IntracardiacDXZ · Traditional | Cormatrix Cardiovascular, Inc. | 07/26/2011SE |
| K101740 | Albosure Polyester Vascular PatchDXZ · Traditional | LeMaitre Vascular, Inc. | 09/20/2010SE |
| K101866 | Cryopatch SG Pulmonary Human Cardiac PatchDXZ · Special | Cryolife, Inc. | 07/23/2010SE |
| K090637 | Cardio-WrapDXZ · Traditional | Mast Biosurgery USA, Inc. | 01/07/2010SESU |
| K091626 | Cryopatch SG Pulmonary Hemi-Artery; Trunk; BranchDXZ · Traditional | Cryolife, Inc. | 08/07/2009SE |
| K082139 | Edwards Bovine Pericardial Patch, Model 4700DXZ · Traditional | Edwards Lifesciences, LLC | 10/23/2008SE |
| K081438 | Matracell Decellularized Pulmonary Artery Patch AllograftDXZ · Traditional | Lifenet Health | 10/17/2008SE |
| K063349 | Cormatrix Patch for Cardiac Tissue RepairDXZ · Traditional | Cormatrix Cardiovascular, Inc. | 02/16/2007SE |
| K060396 | Ivena Vascular PatchDXZ · Traditional | Atrium Medical Corp. | 05/12/2006SE |
| K052416 | Peripro PatchDXZ · Traditional | Hancock/Jaffe Laboratories | 10/25/2005SE |
| K051405 | Regensis Pericardial PatchDXZ · Traditional | Cormatrix Cardiovascular, Inc. | 08/31/2005SE |
| K041736 | Pfa PatchDXZ · Traditional | Peritec Biosciences, LLC | 01/13/2005SE |
| K041716 | PTFE Felts and PledgetsDXZ · Special | Boston Scientific Corp | 07/22/2004SE |
| K040415 | Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and…DXZ · Traditional | Synovis Surgical Innovations | 04/14/2004SE |
| K040162 | Correstore Patch SystemDXZ · Traditional | Somanetics Corp. | 03/16/2004SE |
| K031948 | Peripatch Sheet, Models 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16DXZ · Traditional | Pm Devices, Inc. | 09/16/2003SE |
| K031586 | Correstore Patch SystemDXZ · Traditional | Somanetics Corp. | 08/07/2003SE |
| K022093 | Chase Cardiovascular Patch KitDXZ · Traditional | Chase Medical, Inc. | 09/20/2002SE |
| K021129 | Chare Cariovascular PatchDXZ · Traditional | Chase Medical, Inc. | 06/03/2002SE |
| K020233 | Chase Cardiovascular Patch KitDXZ · Traditional | Chase Medical, Inc. | 03/14/2002SE |
| K020132 | Chase Cardiovascular Patch KitDXZ · Traditional | Chase Medical, Inc. | 02/26/2002SE |
| K011487 | Correstore Patch, Models 1.5P2, 2P3, 3P4; Correstore Sizer, Model CRPSDXZ · Traditional | Somanetics Corp. | 11/21/2001SE |
| K012098 | Preclude Pericardial MembraneDXZ · Traditional | W. L. Gore & Associates, Inc. | 09/20/2001SE |
| K012248 | Chase Cardiovascular PatchDXZ · Traditional | Chase Medical, Inc. | 08/10/2001SE |
| K003467 | Chase Cardiovascular PatchDXZ · Traditional | Chase Medical, Inc. | 01/29/2001SE |
| K001785 | Surgisis Peripheral Vascular PatchDXZ · Traditional | Cook Biotech, Inc. | 12/27/2000SE |
| K003070 | Ethibond Excel Valve Loop SutureDXZ · Traditional | ETHICON, Inc. | 11/07/2000SE |
| K001662 | Chase Cardiovascular PatchDXZ · Traditional | Chase Medical, Inc. | 08/02/2000SE |
| K994032 | Fluoro-Tex Cardiovascular PatchDXZ · Traditional | Bridger Biomed, Inc. | 07/07/2000SE |
| K993288 | Sulzer Carbomedics Cardiofix PericardiumDXZ · Traditional | Sulzer Carbomedics, Inc. | 12/29/1999SE |
| K992776 | Uni-Graft K DV PatchDXZ · Traditional | Atrium Medical Corp. | 11/16/1999SE |
| K984526 | Acuseal Cardiovascular PatchDXZ · Traditional | W. L. Gore & Associates, Inc. | 04/08/1999SE |
| K983602 | CV Peri-Guard and Vascu-GuardDXZ · Special | Bio-Vascular, Inc. | 11/12/1998SE |
| K982810 | Shelhigh No-React VascupatchDXZ · Traditional | Shelhigh, Inc. | 10/28/1998SE |
| K974914 | Shelhigh No-React Pericardial PatchesDXZ · Traditional | Shelhigh, Inc. | 06/03/1998SE |
| K972201 | Patch,Pledget and Intracardiac,Petp,Ptfe,PolypropyleneDXZ · Traditional | Sulzer Carbomedics, Inc. | 04/14/1998SE |
| K971726 | CV Peri-Guard - Cardiovascular PatchDXZ · Traditional | Bio-Vascular, Inc. | 04/10/1998SE |
| K973178 | Fluoro-Tex Surgical MembraneDXZ · Traditional | Bridger Biomed, Inc. | 11/24/1997SE |
| K963967 | Glycar Pericardial PatchDXZ · Traditional | Glycar, Inc. | 10/31/1997SE |
| K963368 | Glycartissue Repair Patch Family of Products; Glycar Vascular Repair Patch Alternative…DXZ · Traditional | Glycar, Inc. | 10/31/1997SE |
| K964467 | Shelhigh Pericardial PatchDXZ · Traditional | Shelhigh, Inc. | 09/23/1997SE |
| K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft Patch,Vascutek…DXZ · Traditional | Vascutek, Ltd. | 11/21/1996SE |
| K962342 | Hemashield Finesse Ultra-Thin, Knitted Cardiovascular PatchDXZ · Traditional | Meadox Medicals, Div. Boston Scientific Corp. | 09/10/1996SE |
| K955349 | Hemashield Knitted Double Velour Cardiovascular FabricDXZ · Traditional | Meadox Medicals, Div. Boston Scientific Corp. | 02/14/1996SE |
| K953425 | Polyethylene Terephthalate (PET) PledgetDXZ · Traditional | Davis & Geck, Inc. | 08/21/1995SE |
| K953289 | Tetrafluoroethylene (Tfe) Polymer PledgetDXZ · Traditional | Davis & Geck, Inc. | 08/21/1995SE |
| K943736 | Cvpro Cardiovascular PatchDXZ · Traditional | W. L. Gore & Associates, Inc. | 02/22/1995SE |
| K942010 | Vascu-GuardDXZ · Traditional | Bio-Vascular, Inc. | 07/07/1994SE |
| K940906 | Gore-Tex Cardiovascular PatchDXZ · Traditional | W. L. Gore & Associates, Inc. | 05/18/1994SE |
| K930950 | Gore-Tex Cardiovascular Patch & Surgical MembraneDXZ · Traditional | W. L. Gore & Associates, Inc. | 10/22/1993SE |
| K931386 | Hemashield Microvel/Woven Double Velour FabricDXZ · Traditional | Meadox Medicals, Div. Boston Scientific Corp. | 05/27/1993SESP |
| K921659 | Ultra Low Porosity Dacron Woven PatchDXZ · Traditional | Intervascular, Inc. | 11/25/1992SESP |
| K921895 | Tissue Patch, Tissue GraftDXZ · Traditional | Bio-Vascular, Inc. | 11/04/1992SESP |
| K905073 | Cardiovascular Repair PatchDXZ · Traditional | Impra, Inc. | 12/20/1991SE |
| K914450 | Gore-Tex(R) Surgical Membrane, Process ChangeDXZ · Traditional | W. L. Gore & Associates, Inc. | 11/05/1991SE |
| K914448 | Gore-Tex(R) Cardiovascular Patch, Process ChangeDXZ · Traditional | W. L. Gore & Associates, Inc. | 11/05/1991SE |
| K912107 | Gore-Tex Expanded Poly. Card. Patch 0.6 and 0.4MMDXZ · Traditional | W. L. Gore & Associates, Inc. | 10/11/1991SE |
| K910464 | Gore-Tex(R) Expanded PTFE Surgical MembraneDXZ · Traditional | W. L. Gore & Associates, Inc. | 03/26/1991SE |
| K905496 | Woven and Knitted Minicrimp Carotid Patch FabricsDXZ · Traditional | Meadox Medicals, Div. Boston Scientific Corp. | 03/11/1991SE |
| K881508 | Ochsner & Micron Fabric PatchDXZ · Traditional | Intervascular, Inc. | 05/25/1988SE |
| K842066 | Peri-Guard Pericardial PatchDXZ · Traditional | Genetic Laboratories, Inc. | 12/30/1985SE |
| K833763 | Pericardial PatchDXZ · Traditional | American Edwards Laboratories | 11/01/1984SE |
| K840262 | Hancock Pericardial PatchDXZ · Traditional | Extracorporeal Medical Specialities, Inc. | 05/30/1984SE |
| K831516 | Gore-Tex Surgical MembraneDXZ · Traditional | W. L. Gore & Associates, Inc. | 01/06/1984SE |
| K833021 | Peri-Guard Pericardial Patch-HerniaDXZ · Traditional | Genetic | 12/26/1983SE |
| K830863 | Hancock Pericardial PatchDXZ · Traditional | Extracorporeal Medical Specialities, Inc. | 08/31/1983SE |
| K830806 | Vascular Graft/Bifurcated/Fep-RingedDXZ · Traditional | W. L. Gore & Associates, Inc. | 08/13/1983SE |
| K823345 | PatchDXZ · Traditional | Shiley, Inc. | 03/10/1983SE |
| K821717 | Gore-Tes Expanded PTFE PatchDXZ · Traditional | W. L. Gore & Associates, Inc. | 01/12/1983SE |
| K821532 | Periguard Pericardial PatchDXZ · Traditional | Genetic Laboratories, Inc. | 08/19/1982SE |
| K811841 | Gore-Tex Cardiovascular PatchDXZ · Traditional | W. L. Gore & Associates, Inc. | 09/16/1981SE |
| K812254 | Dacron Pledget Suture ButtressDXZ · Traditional | ETHICON, Inc. | 08/31/1981SE |
| K811872 | Teflon Pledget Suture ButtressDXZ · Traditional | ETHICON, Inc. | 08/12/1981SE |
| K801764 | Ionescu-Shiley Pericardial PatchDXZ · Traditional | Shiley, Inc. | 08/13/1980SE |
| K791792 | Sci Med Pericardial SubstituteDXZ · Traditional | Scimed Life Systems, Inc. | 12/07/1979SE |
| K770835 | Patch FabricDXZ · Traditional | Usci, Div. C.R. Bard, Inc. | 10/05/1977SE |
| K760516 | Felt, Surgical DacronDXZ · Traditional | Meadox Medicals, Div. Boston Scientific Corp. | 01/05/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0532-2026 Class I | SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH…The impacted lot may not meet the required tensile strength specification. | Glycar SA Pty., Ltd. | 10/09/2025Open, Classified |
| Z-0531-2026 Class I | SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH…The impacted lot may not meet the required tensile strength specification. | Glycar SA Pty., Ltd. | 10/09/2025Open, Classified |
| Z-2532-2024 Class II | (1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00…Grafts were found to have been approved, released, shipped and implanted with an invalid test results. | Artivion, Inc | 05/28/2024Open, Classified |
| Z-0669-2024 Class II | Vascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes: a) VG0108N: 0.8X8 CM…Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed… | Baxter Healthcare Corporation | 12/06/2023Open, Classified |
| Z-0668-2024 Class II | PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG0404: 4 X 4 CM US…Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed… | Baxter Healthcare Corporation | 12/06/2023Open, Classified |
| Z-2543-2021 Class II | The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches.…The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees. | Vascutek, Ltd. | 07/08/2021Terminated |
| Z-0653-2021 Class II | CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a tissue…On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for… | CryoLife, Inc. | 11/10/2020Terminated |
| Z-0121-2019 Class II | CryoPatch SG Pulmonary Hemi-Artery, 1 graftThe conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling.… | CryoLife, Inc. | 09/06/2018Terminated |
| Z-2272-2018 Class II | Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports… | CryoLife, Inc. | 05/14/2018Terminated |
| Z-1172-2018 Class II | HEMASHIELD Knitted Double Velour Cardiovascular FabricA probable mislabeling of the product: a different-sized product is referenced on the product packaging… | Getinge US Sales LLC | 01/03/2018Terminated |
| Z-1219-2019 Class II | CryoPatch SG Pulmonary Hemi-Artery PatchThe device is recalled due to donor ineligibility of released human tissue. The firm received information… | CryoLife, Inc. | 11/21/2016Terminated |
| Z-2533-2016 Class II | Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes:…Baxter is issuing a safety alert in response to postmarketing reports received for the VASC U-GUARD… | Baxter Healthcare Corp. | 06/24/2016Terminated |
| Z-1637-2015 Class I | Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes:…Baxter healthcare is recalling specific product codes of Vascu-Guard Peripheral Vascular Patch due to… | Synovis Surgical Innovations, Inc. | 05/02/2015Terminated |
| Z-0809-2014 Class II | Pulmonary Hemi-Artery SG Used in heart surgerySerological testing for the donor was performed with a blood sample that may have been hemodiluted due to… | CryoLife, Inc. | 11/22/2013Terminated |
| Z-0338-2014 Class II | Vascu Guard, Peripheral Vascular Patch with Apex Processing. For use in peripheral…Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD and… | Synovis Surgical Innovations, Inc. | 10/28/2013Terminated |
| Z-1561-2011 | Pulmonary Hemi-Artery SG Used in heart surgeryStaphylococcus aureus (not methicillin resistant) identified in companion tissue. | CryoLife, Inc. | 02/17/2011Terminated |
| Z-1560-2011 | Pulmonary Valve & Conduit SG Used in heart surgeryStaphylococcus aureus (not methicillin resistant) identified in companion tissue. | CryoLife, Inc. | 02/17/2011Terminated |
| Z-2447-2010 | PSD Gel that's provided with Peri-Strips Dry Staple Line Reinforcement with Apex…Synovis Surgical Innovations is voluntarily recalling PSD Gel that's provided with Peri-Strips Dry Staple… | Synovis Surgical Inovation Div. of | 06/30/2010Terminated |
| Z-2062-2010 | Hemashield Double Velour Cardiovascular Fabrics.Various Hemashield products may develop glycerol droplets on the inner blister of the package if not stored… | Maquet Cardiovascular, LLC | 05/24/2010Terminated |