Home › Device types › DXF
Catheter, Septostomy
FDA product code DXF · Class 2 · Cardiovascular
972
Registered devices
2,144
Adverse events
10
Recalls
21
510(k) clearances
Devices with this code
VersaCross Steerable Access Solution — Baylis Médicale Cie IncNRG RF Transseptal Kit — Baylis Médicale Cie IncVersaCross Steerable Access Solution — Baylis Médicale Cie IncNRG RF Transseptal Kit — Baylis Médicale Cie IncNRG RF Transseptal Kit — Baylis Médicale Cie IncVersaCross Access Solution — Baylis Médicale Cie IncHOTWIRE™ RF GUIDEWIRE — Atraverse Medical, IncNRG RF Transseptal Kit — Baylis Médicale Cie IncVersaCross Access Solution — Baylis Médicale Cie IncVersaCross Access Solution — Baylis Médicale Cie IncNRG RF Transseptal Kit — Baylis Médicale Cie IncSupraCross RF Wire — BOSTON SCIENTIFIC CORPORATIONNRG Large Access Solution — Baylis Médicale Cie IncVersaCross Steerable Access Solution — Baylis Médicale Cie IncVersaCross Access Solution — Baylis Médicale Cie IncVersaCross Steerable Access Solution — Baylis Médicale Cie IncNRG RF Transseptal Kit — Baylis Médicale Cie IncNRG Transseptal Needle — Baylis Médicale Cie IncNRG RF Transseptal Kit — Baylis Médicale Cie IncNRG RF Transseptal Kit — Baylis Médicale Cie IncNRG RF Transseptal Kit — Baylis Médicale Cie IncVersaCross Steerable Access Solution — Baylis Médicale Cie IncHOTWIRE™ RF GUIDEWIRE — Atraverse Medical, IncNRG RF Transseptal Kit — Baylis Médicale Cie Inc
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-06-10 | Boston Scientific Corporation | Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection an |
| 2025-06-10 | Boston Scientific Corporation | Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection an |
| 2025-06-10 | Boston Scientific Corporation | Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection an |
| 2025-06-10 | Boston Scientific Corporation | Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection an |
| 2020-08-25 | Medtronic Vascular | Subsequent failure of catheters in the field and failed quality testing |
| 2020-08-25 | Medtronic Vascular | Subsequent failure of catheters in the field and failed quality testing |
| 2020-08-25 | Medtronic Vascular | Subsequent failure of catheters in the field and failed quality testing |
| 2019-03-28 | Edwards Lifesciences, LLC | Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon fragmentation or detachment. |
| 2019-03-28 | Edwards Lifesciences, LLC | Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon fragmentation or detachment. |
| 2016-10-11 | Baylis Medical Corp * | The firm is voluntarily recalling lots of the NRG Transseptal Needle and NRG RF Transseptal Kit due to the possibility for an integrity defect to the Tyvek pouc |
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