HydroPearl recallZ-0868-2024 · Microvention Inc. · initiated Dec 21, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Microvention Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.
FDA root cause category: Device Design
What the company is doing
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]
Recall details
- Recall number
- Z-0868-2024
- Status
- Open, Classified
- Initiated by the company
- Dec 21, 2023
- Posted by the FDA
- Jan 31, 2024
- Recalling firm
- Microvention Inc.
- Quantity
- 22 units
- Product code
- NOY
- FDA submissions
- K150870, K192684
- Distribution
- U.S. Nationwide distribution in the states of AZ, IL, LA, NC, TN, VA, and WI.
Product description
TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
Code information (models, lots, serial numbers)
Model/Catalog Number: HP2S0600 UDI Code: (01)00816777026118(11)230710(17)260630(10)0000342047 Lot Number: 0000342047
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- HydroPearl HP2S0600Microvention, Inc. · Agents, embolic, for treatment of uterine fibroids1 recall0 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K150870, K192684 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- HydroPearl 8HP2S200Microvention, Inc. · Agents, embolic, for treatment of uterine fibroids1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page