Device recall

Z-0549-2008: ACAT 1 Series Intra-Aortic Balloon Pumps, Catalog # IAP-0100, Arrow…

FDA device recall · Class II · Arrow International Inc

Key facts

Recall number (Z-number) Z-0549-2008
Recall event 45871
Product ACAT 1 Series Intra-Aortic Balloon Pumps, Catalog # IAP-0100, Arrow International, Everett, MA 02149
Product code DSP
Recalling firm Arrow International Inc
Recall class Class II
Status Terminated
Termination date Jan 11, 2010
510(k) numbers K965209
FEI number 3015859709

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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