FDA (Devices) recall action 84727

Microvention, Inc. recalled 16 products on 2020-03-04

The FDA (Devices) publishes a recall like this one as 16 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 16 pages.

Products: 16
Announced: 2020-03-04
Critical: 0
Units: 18,602

Why these products were recalled

The devices may be missing the implant coil.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–16 of 16

HighFDA (Devices)··2020-03-04
MicroVention Platinum Coil System Recall for Missing Implant Coils
MicroVention is recalling Microplex 10 Platinum Coil Systems because the implant coil may be missing from the packaging.
Product
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft Helical, Sterile, Rx, REF numbers 100101HS-V, 100102HS-V, 100103HS-V, 100104HS-V, 100151HS-V, 100152HS-V, 100153HS-V, 100154HS-V, 100201HS-V, 100202HS-V, 100203HS-V, 100204HS-V, 100
Category
Distribution
1 state
HighFDA (Devices)··2020-03-04
MicroVention Platinum Coil System Recalled for Missing Implant Coil
MicroVention is recalling 3,442 units of Platinum Coil Systems because the implant coil may be missing from the packaging.
Product
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Cosmos 10, Sterile, Rx, REF numbers 100202CSSR-V, 100254CSSR-V, 100306CSSR-V, 100408CSSR-V, 100412CSSR-V, 100515CSSR-V, 100522CSSR-V, 100618CSSR-V, 100626CSSR-V, 100722CSSR-V, 100731CSSR-V,
Category
Distribution
1 state
HighFDA (Devices)··2020-03-04
MicroVention Platinum Coil System Recall for Missing Implant Coils
MicroVention is recalling 169 units of Microplex 18 Platinum Coil Systems because the implant coil may be missing from the device.
Product
MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Soft, Sterile, Rx, REF numbers 180204HC-S-V, 180208HC-S-V, 180308HC-S-V, 180410HC-S-V, and 180512HC-S-V. Product Usage: The MCS is also intended for vascular occlusion of blood v
Category
Distribution
1 state
HighFDA (Devices)··2020-03-04
MicroVention HydroFrame 18 Embolic System Recalled for Missing Implant Coil
MicroVention is recalling 32 units of HydroFrame 18 embolic systems because the implant coil may be missing. The devices were distributed internationally.
Product
MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 180723HFRM-V, 180931HFRM-V, 181644HFRM-V, MV-80619HHFA, MV80827HHFA, MV-80931HHFA, and MV-81036HHFA. Product Usage: The HES is also intended for vascular occlu
Category
Distribution
1 state
HighFDA (Devices)··2020-03-04
MicroVention HydroSoft 10 Embolic Coils Recalled for Missing Implant Coil
MicroVention is recalling 2,762 units of HydroSoft 10 embolic coils because the implant coil may be missing from the packaging.
Product
MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, Helical, Sterile, Rx, REF numbers 100101H2HS-V; 100102H2HS-V, 100103H2HS-V, 100104H2HS-V, 100151H2HS-V; 100152H2HS-V; 100153H2HS-V; 100154H2HS-V; 100201H2HS-V; 100202H2HS-V; 100203H2HS-V;
Category
Distribution
1 state
HighFDA (Devices)··2020-03-04
MicroVention Platinum Embolization Coils Recalled for Missing Implant Coil
MicroVention is recalling 403 units of Platinum Embolization Coils because the implant coil may be missing from the device.
Product
MicroVention Terumo Microplex 18, Platinum Embolization Coil, Cosmos 18, Sterile, Rx, REF numbers 180619CS-V, 180723CS-V, 180827CS-V, 180931CS-V, 181036CS-V, 181139CS-V, 181243CS-V, 181347CS-V, 181451CS-V, 181652CS-V, 181859CS-V, 182065CS-V, 182263CS-V, and 182468CS-V; Produc
Category
Distribution
1 state
HighFDA (Devices)··2020-03-04
MicroVention Platinum Coil System Recalled for Missing Implant Coils
MicroVention is recalling 85 units of Microplex 10 Platinum Coil Systems because the implant coil may be missing from the packaging.
Product
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Compass 10, Sterile, Rx, REF numbers 100203CMSR-V, 100408CMSR-V, 100412CMSR-V, 100510CMSR-V, 100516CMSR-V, 100612CMSR-V, 100618CMSR-V, and 100721CMSR-V. Product Usage: The MCS is also inten
Category
Distribution
1 state
HighFDA (Devices)··2020-03-04
MicroVention Platinum Coil System Recalled for Missing Implant Coil
MicroVention, Inc. is recalling 780 units of Microplex 10 Platinum Coil Systems because the implant coil may be missing from the device.
Product
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Soft, Sterile, Rx, REF numbers 100206HCSR-S-V, 100208HC-S-V, 100208HCSR-S-V, 100306HCSR-S-V, 100308HCSR-S-V, 100310HC-S-V, 100310HCSR-S-V, 100410HC-S-V, 100410HCSR-S-V, Product
Category
Distribution
1 state
HighFDA (Devices)··2020-03-04
MicroVention Platinum Coil System Recalled for Missing Implant Coil
MicroVention is recalling 666 units of Platinum Coil Systems because the implant coil may be missing from the device.
Product
MicroVention Terumo Microplex, Platinum Coil System, Endovascular Embolization Coil, VFC, Sterile, Rx, REF numbers MV-00306VFC, MV-00315VFC, MV-00310VFC, MV-00630VFC, VFC010303-V, VFC030606-V, VFC030610-V, VFC030615-V, VFC061020-V, VFC061030-V, VFC101530-V, VFC101540-V, VFC1520
Category
Distribution
1 state
HighFDA (Devices)··2020-03-04
MicroVention Platinum Coil System Recalled for Missing Implant Coil
MicroVention is recalling 486 units of Microplex 10 Platinum Coil Systems because the implant coil may be missing from the device.
Product
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Regular, Sterile, Rx, REF numbers 100515HC-R-V, 100515HCSR-R-V, 100520HC-R-V, 100520HCSR-R-V, 100620HC-R-V, 100620HCSR-R-V, 100730HC-R-V, 100730HCSR-R-V, 100830HC-R-V, 100930HC-R-V
Category
Distribution
1 state
SevereFDA (Devices)··2020-03-04
MicroVention HydroFrame 10 Embolic Coils Recalled for Missing Implant Coil
MicroVention is recalling 991 HydroFrame 10 and HydroCoil embolic systems because the implant coil may be missing. The devices were distributed outside the United States.
Product
MicroVention Terumo HydroFrame 10, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 100306HFRM-V, 100405HFRM-V, 100408HFRM-V, 100410HFRM-V, 100412HFRM-V, 100415HFRM-V, 100510HFRM-V, 100515HFRM-V, 100519HFRM-V, 100612HFRM-V, 100619HFRM-V, 100623HF
Category
Distribution
1 state
HighFDA (Devices)··2020-03-04
MicroVention Platinum Coil System Recalled for Missing Implant Coil
MicroVention is recalling 9 units of Microplex 18 Platinum Coil Systems because the implant coil may be missing from the packaging.
Product
MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Regular, Sterile, Rx, REF numbers 180520HC-R-V and 181230HC-R-V. Product Usage: The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system
Category
Distribution
1 state
HighFDA (Devices)··2020-03-04
MicroVention Platinum Coil System Recalled for Missing Implant Coil
MicroVention is recalling 1,725 units of Microplex 10 Platinum Coil Systems because the implant coil may be missing from the device.
Product
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft 3D, Sterile, Rx, REF numbers 100102HS3D-V, 100103HS3D-V, 100152HS3D-V, 100153HS3D-V, 100154HS3D-V, 100202HS3D-V, 100203HS3D-V, 100204HS3D-V, 100206HS3D-V, 100208HS3D-V, 100254HS3D-V
Category
Distribution
1 state
HighFDA (Devices)··2020-03-04
MicroVention Platinum Coil System Recalled for Missing Implant Coil
MicroVention is recalling 19 units of the Microplex 18 Platinum Coil System because the implant coil may be missing from the device.
Product
MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Complex 18, Sterile, Rx, REF numbers 180512CC-V, 180820CC-V, 181026CC-V, 181434CC-V, and 182050CC-V. Product Usage: The MCS is also intended for vascular occlusion of blood vessels within t
Category
Distribution
1 state
HighFDA (Devices)··2020-03-04
MicroVention Platinum Coil System Recalled for Missing Implant Coil
MicroVention is recalling Microplex 10 Platinum Coil Systems because the implant coil may be missing from the device.
Product
MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Complex 10, Sterile, Rx, REF numbers 100204CC-V, 100307CC-V, 100410CC-V, 100512CC-V, 100615CC-V, 100718CC-V, 100820CC-V, 100924CC-V, and 101026CC-V. Product Usage: The MCS is also intended
Category
Distribution
1 state
HighFDA (Devices)··2020-03-04
MicroVention HydroSoft Embolization Coils Recalled for Missing Implant Coils
MicroVention is recalling 847 HydroSoft embolization coils because the implant coil may be missing from the packaging. The devices were distributed to 43 countries outside the United States.
Product
MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, HydroSoft 3D, Sterile, Rx, REF numbers 100102HFRM-V, 100152HFRM-V, 100153HFRM-V, 100154HFRM-V, 100202HFRM-V, 100206HFRM-V, 100208HFRM-V, 100254HFRM-V, 100256HFRM-V, 100308HFRM-V, MV-00202
Category
Distribution
1 state