Device recall

Z-0868-2024: TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600

FDA device recall · Class II · MICROVENTION INC.

Key facts

Recall number (Z-number) Z-0868-2024
Recall event 93692
Product TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
Product code NOY
Recalling firm MICROVENTION INC.
Recall class Class II
Status Open, Classified
510(k) numbers K150870, K192684
FEI number 3013556777

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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