TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
FDA Recall Z-0868-2024 · Posted 2024-01-31
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Recalling FirmMICROVENTION INC.
Recall StatusOpen, Classified
Product CodeNOY
Date Initiated2023-12-21
Product Quantity22 units
Reason for Recall
Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.
Firm Action
On 12/21/2023, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter via FedEx Overnight Certified Letter to customers informing them that MicroVention is recalling one lot (#00003420470 of HYDRPEARL Microsphere Device (HP2S0600) due to the firm no following the prescribed manufacturing and quality processes and the affected product was inadvertently released for distribution. Specifically, the in-processing ageing step was mistakenly extended an additional five (5) days.
Customers are instructed to:
1. Immediately stop using and quarantine the impacted HYDROPEARL device.
2. Inform all individuals with their organization of the recall and forward to any organizations that they may have received the affected products.
3. Complete the CUSTOMER ACKNOWLEDGEMENT FORM to [email protected]
4. If their institution has any affected inventory, contact Customer Care at 800-888-3786 or email [email protected] to request a recall return and received RGA details to return the device(s).
For questions or assistance, contact Director, Post-Market Surveillance at [email protected]
Root Cause
Device Design
Distribution Pattern
U.S. Nationwide distribution in the states of AZ, IL, LA, NC, TN, VA, and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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