Device recall

Z-1470-2009: Boston Scientific Wiseguide Guide Catheter, Sterilized. Wiseguide catheters are…

FDA device recall · Class II · Boston Scientific Corporation

Key facts

Recall number (Z-number) Z-1470-2009
Recall event 51865
Product Boston Scientific Wiseguide Guide Catheter, Sterilized. Wiseguide catheters are intended for use in general intravascular and coronary applications. They provide a pathway through which medical instruments, such as balloon dilatation catheters, guide wires or other therapeutic devices may be…
Product code DQY
Recalling firm Boston Scientific Corporation
Recall class Class II
Status Terminated
Termination date Jan 7, 2012
510(k) numbers K970823, K974684, K981788
FEI number 3002095335

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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