Device, Neurovascular Embolization
FDA product code HCG · Class 2 · 1,223 devices · 11,944 reports · 37 deaths reported · 336 devices named in recalls
- POD RBYPODJ60-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION355 reports
- Penumbra System SCH1Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION295 reports
- RUBY Coil RBY4C0860-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION276 reports
- Smart Coil 400SMTHXSFT0208Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION165 reports
- Penumbra System RH1-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION154 reports
- Optima Coil System OPTI0208CSS10Balt USA LLC · Device, Neurovascular Embolization3 recalls3 reports
- POD RBYPOD6-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION148 reports
- POD RBYPODJ30-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION132 reports
- POD RBYPODJ60Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION131 reports
- POD RBYPODJ45-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION125 reports
- POD RBYPOD4Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION120 reports
- Smart Coil 400SMTHXSFT0102Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION1 death115 reports
- POD RBYPOD6Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION111 reports
- Optima Coil System OPTI0308CSS10Balt USA LLC · Device, Neurovascular Embolization2 recalls6 reports
- Optima Coil System OPTI0203CSS10Balt USA LLC · Device, Neurovascular Embolization2 recalls3 reports
- Optima Coil System OPTI0256CSS10Balt USA LLC · Device, Neurovascular Embolization2 recalls3 reports
- Optima Coil System OPTI0410CSS10Balt USA LLC · Device, Neurovascular Embolization2 recalls3 reports
- Optima Coil System OPTI0413CSF10Balt USA LLC · Device, Neurovascular Embolization2 recalls3 reports
- RUBY Coil RBY2C1260-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION103 reports
- Optima Coil System OPTI0102CSS10Balt USA LLC · Device, Neurovascular Embolization2 recalls2 reports
- Optima Coil System OPTI0103CSS10Balt USA LLC · Device, Neurovascular Embolization2 recalls2 reports
- Optima Coil System OPTI0206CSS10Balt USA LLC · Device, Neurovascular Embolization2 recalls2 reports
- Optima Coil System OPTI0310CSS10Balt USA LLC · Device, Neurovascular Embolization2 recalls2 reports
- Optima Coil System OPTI0513CSS10Balt USA LLC · Device, Neurovascular Embolization2 recalls2 reports
- Optima Coil System OPTI0407CSF10Balt USA LLC · Device, Neurovascular Embolization2 recalls2 reports
- Optima Coil System OPTI0827CSF10Balt USA LLC · Device, Neurovascular Embolization2 recalls2 reports
- Optima Coil System OPTI0923CST10Balt USA LLC · Device, Neurovascular Embolization2 recalls1 report
- Optima Coil System OPTI0154CSS10Balt USA LLC · Device, Neurovascular Embolization2 recalls1 report
- Optima Coil System OPTI0509CSF10Balt USA LLC · Device, Neurovascular Embolization2 recalls1 report
- Optima Coil System OPTI0517CSF10Balt USA LLC · Device, Neurovascular Embolization2 recalls1 report
- Optima Coil System OPTI0611CSF10Balt USA LLC · Device, Neurovascular Embolization2 recalls1 report
- Optima Coil System OPTI0724CSF10Balt USA LLC · Device, Neurovascular Embolization2 recalls1 report
- Optima Coil System OPTI0923CST10Balt USA LLC · Device, Neurovascular Embolization2 recalls1 report
- Optima Coil System OPTI0204HSS10Balt USA LLC · Device, Neurovascular Embolization2 recalls1 report
- Optima Coil System OPTI0208HSS10Balt USA LLC · Device, Neurovascular Embolization2 recalls1 report
- Optima Coil System OPTI0102CSS10Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0206CSS10Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0256CSS10Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0410CSS10Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0611CSF10Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0724COM18Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0930COM18Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI1034COM18Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI1550COM18Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0103HSS10Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0152HSS10Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0202HSS10Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0204HSS10Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0408HSS10Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0101CSS10Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0304CSS10Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0358CSS10Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0204CSF10Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0206CSF10Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0208CSF10Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0308CSF10Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0310CSF10Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0724COM18Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0930COM18Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI1034COM18Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI1137COM18Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI1550COM18Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0103HSS10Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0104HSS10Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0151HSS10Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0152HSS10Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0153HSS10Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0202HSS10Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0256HSS10Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0308HSS10Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI0408HSS10Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- Optima Coil System OPTI1030HST10Balt USA LLC · Device, Neurovascular Embolization2 recalls0 reports
- RUBY Coil RBY2C3260-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION100 reports
- RUBY Coil RBY2C1035-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION97 reports
- POD RBYPODJ15-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION96 reports
- Smart Coil 400SMTHXSFT0204Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION95 reports
- Smart Coil 400SMTHXSFT0103Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION94 reports
- GALAXY G3 GLM915020Cerenovus, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION1 recall44 reports
- POD RBYPOD8Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION90 reports
- RUBY Coil RBY2C1460-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION89 reports
- RUBY Coil RBY2C2060-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION86 reports
- Smart Coil 400SMTXSFT0103Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION84 reports
- RUBY Coil RBY4C0315-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION79 reports
- RUBY Coil RBY4C0630-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION1 death79 reports
- RUBY Coil RBY4C2060-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION79 reports
- Smart Coil 400SMTXSFT0306Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION77 reports
- LP Coil System RBYLP0204Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION76 reports
- Smart Coil 400SMTXSFT0308Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION75 reports
- Penumbra System DH1Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION72 reports
- Smart Coil 400SMTXSFT0204Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION69 reports
- GALAXY G3 GLM910020Cerenovus, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION67 reports
- RUBY Coil RBY2C1660-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION67 reports
- RUBY Coil RBY2C2457-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION67 reports
- Smart Coil 400SMTHXSFT1H03Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION66 reports
- RUBY Coil RBY2C0435-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION64 reports
- RUBY Coil RBY2C0320-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION63 reports
- Penumbra Coil 400 4002C1245Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION61 reports
- Smart Coil 400SMTHXSFT2H06Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION60 reports
- Smart Coil 400SMTXSFT0208Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION59 reports
- Smart Coil 400SMTXSFT0102Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION58 reports