Device recall

Z-1811-2010: CS100 Intra-Aortic Balloon Pump.

FDA device recall · Class II · Datascope Corporation

Key facts

Recall number (Z-number) Z-1811-2010
Recall event 55649
Product CS100 Intra-Aortic Balloon Pump.
Product code DSP
Recalling firm Datascope Corporation
Recall class Class II
Status Terminated
Termination date Oct 27, 2010
510(k) numbers K031636
FEI number 1000222374

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)