Recall Z-0868-2024 ยท NOY Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
MICROVENTION INC.
TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
| Date | Jan 31, 2024 (initiated Dec 21, 2023) |
| Status | Open, Classified |
| Reason | Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed. |
| Root cause | Device Design |
| 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 indi |
| Quantity | 22 units |
| Distribution | U.S. Nationwide distribution in the states of AZ, IL, LA, NC, TN, VA, and WI. |
| FDA record | Open on fda.gov |