Home › Device types › DXZ
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
FDA product code DXZ · Class 2 · Cardiovascular
964
Registered devices
1,498
Adverse events
20
Recalls
90
510(k) clearances
Devices with this code
CardioGRAFT-MC™ — LIFENET HEALTHHemashield — INTERVASCULAR SASDEKNATEL — TELEFLEX INCORPORATEDCardioGRAFT-MC™ — LIFENET HEALTHCardioGRAFT-MC™ — LIFENET HEALTHGORE-TEX Cardiovascular Patch — W. L. Gore & Associates, Inc.Thinwall — VASCUTEK LTDCardioCel Neo — ADMEDUS REGEN PTY LTDCardioGRAFT-MC™ — LIFENET HEALTHReTAP® Cardiovascular Patch — SOLINAS MEDICAL INC.CardioGRAFT-MC™ — LIFENET HEALTHMannequin™ Endoventricular Shaper — KDL MEDICAL, INC.CardioCel Neo — ADMEDUS REGEN PTY LTDETHIBOND EXCEL — ETHICON, LLCCardioGRAFT-MC™ — LIFENET HEALTHCardioGRAFT-MC™ — LIFENET HEALTHCardioGRAFT-MC™ — LIFENET HEALTHCardioGRAFT-MC™ — LIFENET HEALTHVASCU-GUARD Peripheral Vascular Patch — SYNOVIS LIFE TECHNOLOGIES, INC.CardioGRAFT-MC™ — LIFENET HEALTHCardioGRAFT-MC™ — LIFENET HEALTHDEKNATEL — TELEFLEX INCORPORATEDCardioGRAFT-MC™ — LIFENET HEALTHTutopatch™ ECM 8 cm x 14 cm — Tutogen Medical GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-09 | Glycar SA Pty., Ltd. | The impacted lot may not meet the required tensile strength specification. |
| 2025-10-09 | Glycar SA Pty., Ltd. | The impacted lot may not meet the required tensile strength specification. |
| 2024-05-28 | Artivion, Inc | Grafts were found to have been approved, released, shipped and implanted with an invalid test results. |
| 2023-12-06 | Baxter Healthcare Corporation | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align wi |
| 2023-12-06 | Baxter Healthcare Corporation | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align wi |
| 2021-07-08 | Vascutek, Ltd. | The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees. |
| 2020-11-10 | CryoLife, Inc. | On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for other allografts, processed using a TRIS saline solu |
| 2018-09-06 | CryoLife, Inc. | The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling. The graft labeling indicates the conduit length is 1. |
| 2018-05-14 | CryoLife, Inc. | Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine. |
| 2018-01-03 | GETINGE US SALES LLC | A probable mislabeling of the product: a different-sized product is referenced on the product packaging label (i.e. 2.5 cm (width) x 7.6 cm (length)) while the |
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