CLASS II ONGOING Device recall · Reported 7 Feb 2024 · FDA Enforcement Report

Terumo HydroPearl Compressible Microspheres for Embolisation recalled

Microvention is recalling Terumo HydroPearl Compressible Microspheres for Embolisation, distributed nationwide in the US. The recall was initiated on 21 Dec 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/Catalog Number: HP2S0600 UDI Code: (01)00816777026118(11)230710(17)260630(10)0000342047 Lot Number: 0000342047

Quantity recalled22 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0868-2024
FDA event ID: 93692
Recalling firm: Microvention, Aliso Viejo, CA
Classification: Class II
Status: Ongoing
Recall initiated: 21 Dec 2023
FDA classified: 31 Jan 2024
Reported: 7 Feb 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

21 Dec 2023	Recall initiated by company
31 Jan 2024	Classified by FDA	+41 days
7 Feb 2024	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.

Product as listed by the FDA

TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600

Where it was distributed

U.S. Nationwide distribution in the states of AZ, IL, LA, NC, TN, VA, and WI.

Nationwide Arizona Illinois Louisiana North Carolina Tennessee Virginia Wisconsin

Questions about this recall

Why was it recalled?

Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.

Which lots are affected?

Model/Catalog Number: HP2S0600 UDI Code: (01)00816777026118(11)230710(17)260630(10)0000342047 Lot Number: 0000342047

Where was it sold?

U.S. Nationwide distribution in the states of AZ, IL, LA, NC, TN, VA, and WI.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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