Device recall

Z-0177-2015: St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model…

FDA device recall · Class II · St Jude Medical

Key facts

Recall number (Z-number) Z-0177-2015
Recall event 69512
Product St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
Product code DRF
Recalling firm St Jude Medical
Recall class Class II
Status Terminated
Termination date Dec 10, 2014
510(k) numbers K894500
FEI number 3007562768

At a glance

  • 1–9 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

Browse all FDA device recalls (products)