Microvention recalls HydroPearl Compressible Microspheres (REF 8HP2S600) due to manufacturing defects that may affect safety. Learn if your product is affected and what to do.
Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.
Microvention is recalling HydroPearl Compressible Microspheres for Embolisation (REF 8HP2S600) because they were distributed without following proper manufacturing and quality processes. This defect could lead to safety issues if used improperly.
The product was distributed without following the prescribed manufacturing and quality processes. This defect could potentially cause safety issues during medical procedures if the device is used without proper quality assurance.
Patients using this medical device for embolisation procedures are likely affected. Medical professionals who have received the product may also be at risk.
Check for the model number HP2S0600 and the lot number 0000342047 on the product label. The UDI code (01)00816777026118(11)230710(17)260630(10)0000342047 is also associated with this recall.
Look for the model number HP2S0600 and lot number 0000342047 on the device label.
The recall record states that the product was distributed without following proper manufacturing and quality processes, but does not specify if it is safe to use.
The recall record does not provide a remedy or action steps for affected products.
Check for the model number HP2S0600 and lot number 0000342047 on the product label.
We’ve drafted a message you can send Microvention to request your refund or repair — edit it as you like.
Subject: Recall Z-0868-2024 — Microvention Microvention Hello, I own a Microvention that is covered by recall Z-0868-2024 from Microvention. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
