TERUMO HydroPearl embolization microspheres recalled for manufacturing process deviation
MICROVENTION is recalling TERUMO HydroPearl Compressible Microspheres because manufacturing and quality processes were not followed during production. The recall affects 22 units distributed in seven U.S. states.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II precautionary recall with no reported illnesses, injuries, or identified specific hazard. Manufacturing process non-compliance without confirmed product defects or safety impacts fits the precautionary recall category.
Plain-English summary
MICROVENTION INC. is recalling the TERUMO HydroPearl Compressible Microspheres for Embolisation (Model HP2S0600, Lot Number 0000342047). The product is used in embolization procedures. The recall affects 22 units distributed across the United States.
The recall was initiated because the prescribed manufacturing and quality processes were not followed during production. As a result, the product was inadvertently distributed despite these process deviations.
The affected product was distributed to healthcare facilities in Arizona, Illinois, Louisiana, North Carolina, Tennessee, Virginia, and Wisconsin. Patients or healthcare providers who have received this product should consult with their healthcare provider or contact MICROVENTION INC. for further guidance. Additional information is available on the FDA website.
The recalled product
- Product
- TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
- Manufacturer
- MICROVENTION INC.
- Affected units
- 22
Distribution
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