Device recall

Z-1054-06: 5F ZUMA SR3.0 CATHETER ZM5SR30 Z2 5F 100CM SR30 Coronary Guiding catheter…

FDA device recall · Class II · Medtronic, Inc.

Key facts

Recall number (Z-number) Z-1054-06
Recall event 35236
Product 5F ZUMA SR3.0 CATHETER ZM5SR30 Z2 5F 100CM SR30 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: ZM5SR30
Product code DQY
Recalling firm Medtronic, Inc.
Recall class Class II
Status Terminated
Termination date Jun 20, 2007
510(k) numbers K990707
FEI number 1220452

At a glance

  • 1–9 Linked 510(k)s
  • 100–999 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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