Device recall

Z-1032-2012: The 1500T9 Cardiac Ablation Generator, RO#lBl-89000 is part of the Therapy…

FDA device recall · Class II · St Jude Medical Inc

Key facts

Recall number (Z-number) Z-1032-2012
Recall event 60996
Product The 1500T9 Cardiac Ablation Generator, RO#lBl-89000 is part of the Therapy Cardiac Ablation System, along with the Cool Point irrigation Pump, the Therapy 1300 Series Steerable Ablation Catheters, the Therapy Cool Path Ablation Catheters and accessories. The generator is a microprocessor-controlled…
Product code OAD
Recalling firm St Jude Medical Inc
Recall class Class II
Status Terminated
Termination date Sep 4, 2014
PMA numbers P060019
FEI number 2126673

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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