Device recall

Z-0368-2010: Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 4mm Catheters…

FDA device recall · Class II · BioSense Webster, Inc.

Key facts

Recall number (Z-number) Z-0368-2010
Recall event 50784
Product Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 4mm Catheters; Part Numbers: D-1257-01 & D-1257-02
Product code LPB
Recalling firm BioSense Webster, Inc.
Recall class Class II
Status Terminated
Termination date Nov 23, 2009
PMA numbers P990025, P990025S009
FEI number 3003248396

At a glance

  • None 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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