Device recall

Z-1914-2008: Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/25 cm, sterile…

FDA device recall · Class II · Boston Scientific Corp

Key facts

Recall number (Z-number) Z-1914-2008
Recall event 48079
Product Boston Scientific LeVeen SuperSlim Needle Electrode, 2.0 cm/25 cm, sterile, Boston Scientific, Spencer, IN; REF 26-227, UPN M001262270. The product is used with radiofrequency generator for the thermal coagulation necrosis of soft tissues,including partial or complete ablation of nonresectable liver…
Product code GEI
Recalling firm Boston Scientific Corp
Recall class Class II
Status Terminated
Termination date Aug 4, 2009
510(k) numbers K982556
FEI number 1828132

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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