Device recall

Z-1760-2025: Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to…

FDA device recall · Class I · Centerline Biomedical Inc

Key facts

Recall number (Z-number) Z-1760-2025
Recall event 96697
Product Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
Product code DQK
Recalling firm Centerline Biomedical Inc
Recall class Class I
Status Open, Classified
510(k) numbers K190106, K230309, K241243, K242133, K243842
FEI number 3012154226

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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

Browse all FDA device recalls (products)