Device recall

Z-0567-2008: Datascope CS 100 Intra-Aortic Balloon Pump and Datascope CS 300 Intra-Aortic…

FDA device recall · Class II · Datascope Corp

Key facts

Recall number (Z-number) Z-0567-2008
Recall event 45957
Product Datascope CS 100 Intra-Aortic Balloon Pump and Datascope CS 300 Intra-Aortic Balloon Pump, Datascope Corp. Mahwah, NJ 07430
Product code DSP
Recalling firm Datascope Corp
Recall class Class II
Status Terminated
Termination date May 20, 2008
510(k) numbers K03166636
FEI number 2221819

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

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