Device recall

Z-0383-2007: Boston Scientific Mach 1 Guide Catheter Femoral Approach, 6F, 0.070'', Voda Left…

FDA device recall · Class II · Boston Scientific

Key facts

Recall number (Z-number) Z-0383-2007
Recall event 37001
Product Boston Scientific Mach 1 Guide Catheter Femoral Approach, 6F, 0.070'', Voda Left Curve, UPN # H74934356710, Catalog # 34356-71. Made in Mexico: Edificio G1 Local B, H, Parque Industrial La Mesa, Tijuana, Baja California 22650 MEX.
Product code DQY
Recalling firm Boston Scientific
Recall class Class II
Status Terminated
Termination date Jun 28, 2007
510(k) numbers K010874
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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