Device recall

Z-1061-05: Polystan Coronary Cannula Balloon Tip. (Cardiopulmonary bypass vascular…

FDA device recall · Class II · Maquet Inc

Key facts

Recall number (Z-number) Z-1061-05
Recall event 32267
Product Polystan Coronary Cannula Balloon Tip. (Cardiopulmonary bypass vascular catheter).
Product code DWF
Recalling firm Maquet Inc
Recall class Class II
Status Terminated
Termination date Oct 3, 2006
FEI number 3008355164

At a glance

  • None 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)