Device recall

Z-0969-2014: Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter…

FDA device recall · Class II · Boston Scientific Corporation

Key facts

Recall number (Z-number) Z-0969-2014
Recall event 67437
Product Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H74939186251210, Catalog # 39186-25121.
Product code LIT
Recalling firm Boston Scientific Corporation
Recall class Class II
Status Terminated
Termination date Aug 4, 2014
510(k) numbers K111295
FEI number 3002095335

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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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