Home › Device types › DQE
Catheter, Oximeter, Fiber-Optic
FDA product code DQE · Class 2 · Cardiovascular
205
Registered devices
1,096
Adverse events
14
Recalls
19
510(k) clearances
Devices with this code
ICU Medical — ICU MEDICAL, INC.SWAN-GANZ PACEPORT — Edwards Lifesciences LLCICU Medical — ICU MEDICAL, INC.HEMOSPHERE — Edwards Lifesciences LLCICU Medical — ICU MEDICAL, INC.FLOTRAC, TRUWAVE — Edwards Lifesciences LLCEDWARDS OXIMETRY CENTRAL VENOUS CATHETER — Edwards Lifesciences LLCICU Medical — ICU MEDICAL, INC.SWAN-GANZ TRUE SIZE — Edwards Lifesciences LLCICU Medical — ICU MEDICAL, INC.HemoSphere — Edwards Lifesciences LLCSWAN-GANZ CONTROLCATH TRUE SIZE — Edwards Lifesciences LLCSWAN-GANZ TRUE SIZE — Edwards Lifesciences LLCSWAN-GANZ VIP — Edwards Lifesciences LLCICU Medical — ICU MEDICAL, INC.ICU Medical — ICU MEDICAL, INC.ICU Medical — ICU MEDICAL, INC.ICU Medical — ICU MEDICAL, INC.HemoSphere — Edwards Lifesciences LLCICU Medical — ICU MEDICAL, INC.ICU Medical — ICU MEDICAL, INC.SWAN-GANZ TRUE SIZE — Edwards Lifesciences LLCICU Medical — ICU MEDICAL, INC.SWAN GANZ — Edwards Lifesciences LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-07-09 | Edwards Lifesciences, LLC | There is a potential for internal leaks within catheters. |
| 2021-07-09 | Edwards Lifesciences, LLC | There is a potential for internal leaks within catheters. |
| 2021-07-09 | Edwards Lifesciences, LLC | There is a potential for internal leaks within catheters. |
| 2021-07-09 | Edwards Lifesciences, LLC | There is a potential for internal leaks within catheters. |
| 2021-07-09 | Edwards Lifesciences, LLC | There is a potential for internal leaks within catheters. |
| 2021-07-09 | Edwards Lifesciences, LLC | There is a potential for internal leaks within catheters. |
| 2020-03-27 | Edwards Lifesciences, LLC | Sterile catheter kit packaging compromised. |
| 2020-01-02 | ICU Medical, Inc. | Inability for the guidewire to pass through the needles included with the catheter kits. |
| 2020-01-02 | ICU Medical, Inc. | Inability for the guidewire to pass through the needles included with the catheter kits. |
| 2020-01-02 | ICU Medical, Inc. | Inability for the guidewire to pass through the needles included with the catheter kits. |
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