Food, drugs, devices › MICROVENTION INC.

Device recall: TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600

FDA enforcement event 93692 · Class II · initiated 21 Dec 2023 · status Ongoing

DeviceVoluntary: Firm initiated1 product recordAliso Viejo, CA

MICROVENTION INC. (Aliso Viejo, CA) initiated this device recall on 21 Dec 2023; FDA lists 1 product record under event 93692, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 917 device enforcement events initiated in 2023 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. MICROVENTION INC. has 16 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

MICROVENTION INC., Aliso Viejo, CA.

Reason for recall

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

Distribution

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

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0868-2024	TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600	22 units	Class II	Ongoing	7 Feb 2024

Context

88%of 2023 device events are Class II917 events that year

1product record in this eventfirm median: 1

16events on this register for the firm

Other enforcement events for MICROVENTION INC.

Initiated	Product (first record)	Type	Class	Records
30 Apr 2026	BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facilitating	Device	Class II	1
6 Apr 2026	LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 m	Device	Class II	1
5 Sep 2025	Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED551	Device	Class II	1
29 May 2025	LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400	Device	Class II	1
11 Dec 2024	MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297	Device	Class II	1
2 Dec 2024	Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx On	Device	Class II	1
5 Aug 2024	ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval Device is a mechanical thrombectomy device desi	Device	Class II	1
24 Aug 2023	AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324	Device	Class II	1
7 Jun 2023	FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED352	Device	Class II	1
21 Sep 2022	WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.	Device	Class II	1

All 16 events for MICROVENTION INC.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "U.S. Nationwide distribution in the states of AZ, IL, LA, NC, TN, VA, and WI."

Is the recall still ongoing?

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.