Home › Device types › MAF
Stent, Coronary
FDA product code MAF · Class 3 · Unknown
533
Registered devices
23,279
Adverse events
22
Recalls
0
510(k) clearances
Devices with this code
NIRxcell CoCr Coronary Stent on RX System — MEDINOL LTD.PRO-Kinetic Energy — Biotronik AGREBEL™ — BOSTON SCIENTIFIC CORPORATIONExpress²® — BOSTON SCIENTIFIC CORPORATIONNIRxcell CoCr Coronary Stent on RX System — MEDINOL LTD.VeriFLEX™ — BOSTON SCIENTIFIC CORPORATIONMULTI-LINK MINI VISION — ABBOTT VASCULAR INC.MULTI-LINK VISION — ABBOTT VASCULAR INC.Integrity — MEDTRONIC, INC.Cobra PzF — CELONOVA BIOSCIENCES, INC.Cobra PzF — CELONOVA BIOSCIENCES, INC.PRO-Kinetic Energy — Biotronik AGVeriFLEX™ — BOSTON SCIENTIFIC CORPORATIONMULTI-LINK VISION — ABBOTT VASCULAR INC.Integrity — MEDTRONIC, INC.VeriFLEX™ — BOSTON SCIENTIFIC CORPORATIONGraftmaster — ABBOTT VASCULAR INC.NIRxcell CoCr Coronary Stent on RX System — MEDINOL LTD.Integrity — MEDTRONIC, INC.Cobra PzF — CELONOVA BIOSCIENCES, INC.WALLSTENT® Endoprosthesis — BOSTON SCIENTIFIC CORPORATIONMULTI-LINK VISION — ABBOTT VASCULAR INC.Integrity — MEDTRONIC, INC.WALLSTENT® Endoprosthesis — BOSTON SCIENTIFIC CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-10-24 | Boston Scientific Corporation | Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious sur |
| 2017-02-16 | Cordis Corporation | Deployment Difficulty. |
| 2009-09-11 | Boston Scientific Corporation | Boston Scientific initiated a field correction for the Liberte Bare-Metal coronary stent products. They have received reports from cardiac cath labs that TAXU |
| 2009-06-17 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation | Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures. |
| 2009-06-17 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation | Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures. |
| 2009-06-17 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation | Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures. |
| 2009-06-17 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation | Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures. |
| 2008-11-05 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation | The recall was initiated after Abbott Vascular received reports the protective, yellow balloon sheath of the 4.5mm diameter VOYAGER NC Coronary Dilatation Cathe |
| 2007-07-16 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation | The affected single lot did not meet an internal specification. One unit failed the test criteria for stent dislodgment testing. |
| 2005-04-28 | Edwards Lifesciences Llc | Potential for deployment difficulties. |
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