Device recall

Z-1486-2026: CS100 IABP. Software Version CS100 IABP Q.01.

FDA device recall · Class II · Datascope Corp.

Key facts

Recall number (Z-number) Z-1486-2026
Recall event 98189
Product CS100 IABP. Software Version CS100 IABP Q.01.
Product code DSP
Recalling firm Datascope Corp.
Recall class Class II
Status Open, Classified
510(k) numbers K031636
FEI number 3001418283

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)