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AuST Steerable Sheath
CENTERPOINT SYSTEMS LLC · Model 0-085H-H2274SAN0-SNCP0 · UDI-DI 00810024671243
1
510(k) clearances
13,804
Adverse events (251 deaths)
10
Recalls
45
Facilities
Description
The AuST Steerable Sheath is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.
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 dilator insertion orient |
| 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 dilator insertion orient |
| 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 dilator insertion orient |
| 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 dilator insertion orient |
| 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 POLARSHEATH devices. This |
| 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 liners were found to dis |
| 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 3FC12. There wave bee |
| 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 into the catheter w |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.