Home › Device types › DYG
Catheter, Flow Directed
FDA product code DYG · Class 2 · Cardiovascular
235
Registered devices
4,863
Adverse events
49
Recalls
99
510(k) clearances
Devices with this code
ARROW — TELEFLEX INCORPORATEDARROW — TELEFLEX INCORPORATEDSWAN-GANZ — Edwards Lifesciences LLCVenos Occlusion Balloon Catheter — Oscor Inc.SWAN GANZ — Edwards Lifesciences LLCGraftmaster — ABBOTT VASCULAR INC.SWAN-GANZ CCOMBO — Edwards Lifesciences LLCARROW — TELEFLEX INCORPORATEDTransonic — TRANSONIC SYSTEMS INC.SWAN GANZ — Edwards Lifesciences LLCARROW — TELEFLEX INCORPORATEDARROW — TELEFLEX INCORPORATEDARROW — TELEFLEX INCORPORATEDPruitt Occlusion Catheter — Lemaitre Vascular, Inc.CORODYN — B. BRAUN MEDICAL INC.ARROW — TELEFLEX INCORPORATEDARROW — TELEFLEX INCORPORATEDGraftmaster — ABBOTT VASCULAR INC.ARROW — TELEFLEX INCORPORATEDARROW — TELEFLEX INCORPORATEDAttain™ — MEDTRONIC, INC.Transonic — TRANSONIC SYSTEMS INC.ARROW — TELEFLEX INCORPORATEDGraftmaster — ABBOTT VASCULAR INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-08 | Becton, Dickinson and Company | Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medica |
| 2026-04-08 | Becton, Dickinson and Company | Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medica |
| 2025-04-11 | LeMaitre Vascular, Inc. | During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier). |
| 2023-02-14 | Edwards Lifesciences, LLC | There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor |
| 2023-02-14 | Edwards Lifesciences, LLC | There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor |
| 2019-11-15 | Arrow International Inc | Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the ball |
| 2019-11-15 | Arrow International Inc | Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the ball |
| 2018-12-21 | Edwards Lifesciences, LLC | These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and C |
| 2018-12-21 | Edwards Lifesciences, LLC | These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and C |
| 2018-12-21 | Edwards Lifesciences, LLC | These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and C |
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