Home › Device types › DRA
Catheter, Steerable
FDA product code DRA · Class 2 · Cardiovascular
147
Registered devices
13,804
Adverse events
10
Recalls
42
510(k) clearances
Devices with this code
Livewire™ — ST. JUDE MEDICAL, INC.AuST Steerable Sheath — CENTERPOINT SYSTEMS LLCAuST Steerable Sheath — CENTERPOINT SYSTEMS LLCFlexCath Advance™ — MEDTRONIC, INC.Magellan™ — HANSEN MEDICAL, INC.AuST Steerable Sheath — CENTERPOINT SYSTEMS LLCMagellan™ — HANSEN MEDICAL, INC.Livewire™ — ST. JUDE MEDICAL CARDIOVASCULAR DIVISIONMagellan™ — HANSEN MEDICAL, INC.AuST Steerable Sheath — CENTERPOINT SYSTEMS LLCSTEERABLE GUIDE CATHETER — ABBOTT VASCULAR INC.Dexterity Steerable Introducer — PRIMO MEDICAL GROUPLivewire™ — ST. JUDE MEDICAL CARDIOVASCULAR DIVISIONAuST Steerable Sheath — CENTERPOINT SYSTEMS LLCSteerable Introducer Sheath 12F — FREUDENBERG MEDICAL, LLCFlexCath™ Select — MEDTRONIC, INC.AcQGuide — ACUTUS MEDICAL, INC.Livewire™ — ST. JUDE MEDICAL CARDIOVASCULAR DIVISIONLivewire™ — ST. JUDE MEDICAL, INC.FlexCath Advance™ — MEDTRONIC, INC.Magellan™ — HANSEN MEDICAL, INC.AuST Steerable Sheath — CENTERPOINT SYSTEMS LLCAuST Steerable Sheath — CENTERPOINT SYSTEMS LLCAuST Steerable Sheath — CENTERPOINT SYSTEMS LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-11 | Boston Scientific Corporation | Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dila |
| 2026-06-11 | Boston Scientific Corporation | Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dila |
| 2026-06-11 | Boston Scientific Corporation | Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dila |
| 2026-06-11 | Boston Scientific Corporation | Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dila |
| 2024-02-12 | Boston Scientific Corporation | Boston Scientific has identified a tooling error in manufacturing which may have caused delamination of the inner lumen of the sheath shaft in a subset of POLAR |
| 2021-08-24 | Medtronic Perfusion Systems | Potential for a wire protrusion through the left heart vent catheter tip |
| 2021-08-24 | Medtronic Perfusion Systems | Potential for a wire protrusion through the left heart vent catheter tip |
| 2012-09-06 | Greatbatch Medical | During the investigation of four returned Z Flex 270 Steerable Sheaths that were used with cardiac cryoablation balloon catheters, the internal PTFE sheath line |
| 2011-07-15 | Medtronic Inc. Cardiac Rhythm Disease Management | Medtronic CryoCath would like to inform you of an observation related to a potential leak in the hemostatic valve of the Flex Cath 12 Steerable Sheath, Model 3F |
| 2008-05-21 | Hansen Medical Inc | The catheter's flexible bellows portion may develop a leak. This has the potential to cause loss of hemostasis, flush fluid leakage, and/or introduction of air |
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