Device recall

Z-2417-2011: Pinnacle Destination Guiding Sheath, 6 French, 45 cm, Hockey Stick Tip…

FDA device recall · Class II · Terumo Medical Corporation

Key facts

Recall number (Z-number) Z-2417-2011
Recall event 58677
Product Pinnacle Destination Guiding Sheath, 6 French, 45 cm, Hockey Stick Tip, Tuohy-Borst Valve, Lot ME07, 510 (K) K012854 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the…
Product code DYB
Recalling firm Terumo Medical Corporation
Recall class Class II
Status Terminated
Termination date Jul 7, 2011
510(k) numbers K012854
FEI number 1118880

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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