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NIRxcell CoCr Coronary Stent on RX System
MEDINOL LTD. · Model NXL35033US · UDI-DI 07290107010993
MAF
Prescription
0
510(k) clearances
23,279
Adverse events (1,758 deaths)
22
Recalls
21
Facilities
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 surface on the devices, |
| 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 TAXUS Liberte Paclitaxel |
| 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 Catheter has been tight. |
| 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.