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FlexCath Contour™
MEDTRONIC, INC. · Model 10FCC13 · UDI-DI 00763000659080
DRA
Prescription
1
510(k) clearances
13,804
Adverse events (251 deaths)
10
Recalls
45
Facilities
Description
SHEATH 10FCC13 FLEXCATH CONTOUR 10F US
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.