Device recall

Z-0609-2009: DLP(R) Pericardial/Intracardiac Sump Cannulae, 20 Fr., P/N: 12112. This product…

FDA device recall · Class II · Medtronic Cardiovascular Revascularization & Surgical Therap

Key facts

Recall number (Z-number) Z-0609-2009
Recall event 50173
Product DLP(R) Pericardial/Intracardiac Sump Cannulae, 20 Fr., P/N: 12112. This product is intended for draining the pericardial sac or the cardiac chambers.
Product code DWF
Recalling firm Medtronic Cardiovascular Revascularization & Surgical Therap
Recall class Class II
Status Terminated
Termination date May 7, 2011
510(k) numbers K850385
FEI number 1000116158

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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