Device recall

Z-1834-2010: Ultraflex Tracheobronchial Stent System. Uncovered - 18/40 Catalog Number…

FDA device recall · Class II · Boston Scientific Corporation

Key facts

Recall number (Z-number) Z-1834-2010
Recall event 55784
Product Ultraflex Tracheobronchial Stent System. Uncovered - 18/40 Catalog Number: M00569260. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms.
Product code JCT
Recalling firm Boston Scientific Corporation
Recall class Class II
Status Terminated
Termination date Oct 20, 2011
510(k) numbers K012883
FEI number 3005099803

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 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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