Home › Device types › KRA
Catheter, Continuous Flush
FDA product code KRA · Class 2 · Cardiovascular
1,842
Registered devices
9,137
Adverse events
96
Recalls
177
510(k) clearances
Devices with this code
SWAN-GANZ — Edwards Lifesciences LLCRecana Introducer Sheath, 16Fr x 30cm — Intervene, Inc.Merit Maestro® — Merit Medical Systems, Inc.Merit Maestro® — Merit Medical Systems, Inc.Fountain® — Merit Medical Systems, Inc.TRUWAVE, VAMP — Edwards Lifesciences LLCUni-Fuse+ — Angiodynamics, Inc.pVasc Aspiration Catheter 70, 125 cm — VesalioMistique® — Merit Medical Systems, Inc.PulseSpray — Angiodynamics, Inc.SWAN-GANZ TRUE SIZE — Edwards Lifesciences LLCPhenom™ Catheter — CATHERA, INC.PulseSpray — Angiodynamics, Inc.EkoSonic® — BOSTON SCIENTIFIC CORPORATIONMerit Maestro® — Merit Medical Systems, Inc.ICU Medical — ICU MEDICAL, INC.FloTrac IQ, VAMP Optima — Edwards Lifesciences LLCMerit Maestro® — Merit Medical Systems, Inc.Medex — ICU MEDICAL, INC.Direxion™ Fathom™-16 System — BOSTON SCIENTIFIC CORPORATIONSolitaire™ X-PACK — Micro Therapeutics, Inc.Bashir™ Endovascular Catheter — THROMBOLEX, INC.Merit Maestro® — Merit Medical Systems, Inc.Phenom™ Catheter — CATHERA, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-18 | Angiodynamics, Inc. | Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication. |
| 2023-11-06 | Merit Medical Systems, Inc. | The sterility of microcatheter and infusion system devices cannot be guaranteed. |
| 2022-06-30 | Micro Therapeutics, Inc. | Outer carton packaging of microcatheters were exposed to wet substance during transport. |
| 2022-06-30 | Micro Therapeutics, Inc. | Outer carton packaging of microcatheters were exposed to wet substance during transport. |
| 2020-11-03 | Boston Scientific Corporation | This is a follow-up to the EKOS Field Safety Notice dated April 30, 2019. The Radio Frequency (RF) board has been redesigned to prevent occasional internal boar |
| 2019-11-08 | Cook Inc. | A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) an |
| 2019-11-08 | Cook Inc. | A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) an |
| 2019-11-08 | Cook Inc. | A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) an |
| 2019-11-08 | Cook Inc. | A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) an |
| 2017-11-09 | Vascular Insights, LLC | Certain catheters could have a compromised catheter shaft due to a manufacturing defect which could result in some delamination of the catheter shaft including |
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