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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a missing critical component (implant coil) in a medical device used for vascular occlusion, which poses a risk of harm if the device is used without the coil, although no specific injuries are reported in the source text.
Plain-English summary
MicroVention, Inc. is recalling 2,762 units of the MicroVention Terumo HydroSoft 10 HydroCoil Embolic System. The recall was initiated because the devices may be missing the implant coil. The affected products are endovascular embolization coils intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation, as well as for arterial and venous embolizations in the peripheral vasculature.
The recall covers specific reference numbers and lot numbers, including 100101H2HS-V, 100102H2HS-V, and others listed in the official notice. All distribution of the affected product was outside the United States (OUS). The countries receiving the affected product include Albania, Austria, Belarus, Belgium, Brazil, Bulgaria, China, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Malta, Morocco, Netherlands, Norway, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Turkey, Ukraine, United Arab Emirates, and United Kingdom.
Healthcare providers and distributors should check their inventory for the specific reference and lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to MicroVention, Inc. according to the firm's instructions.
The recalled product
- 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…
- Manufacturer
- Microvention, Inc.
- Hazard
- Affected units
- 2,762
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Catalog/lot numbers: 100101H2HS-V - 1903135UR
- 1903185UR
- 1903225UR
- and 1904035UR
- 100102H2HS - V -1903135UR
- 1903155UR
- 1903155ZR
- 1903205UR
- 1904035UR
- 1904055UR
- 1904085UR
- 1904105UR
- 1904155UR
- 1904175UR
- 1904175ZR
- and 1904245UR
- 100103H2HS-V - 1903015UR
- 1903045UR
- 1903065UR
- 1903085UR
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 16 recalled by Microvention, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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