Sarns Cardioplegia Cannulae (Var. Types

• 2 recalls, same reason

  • Terminated Z-2555-2011 FDA Unclassified (pre-2012) ·initiated 16 May 2011
  • Terminated Z-2556-2011 FDA Unclassified (pre-2012) ·initiated 16 May 2011

  The presence of adhesive and/or skiving of plastic material observed inside the distal tip of the cannula, which could lead to particulate and/or decrease in the internal diameter. The plastic skiving may detach and enter the patient, embolizing the coronary vasculature. The potential risk due to decrease in the internal tip diameter is inadequate delivery of cardioplegia and/or prolonged procedu

• • Terminated Z-2554-2011 FDA Unclassified (pre-2012) ·initiated 16 May 2011

  Terumo has discovered several instances of adhesive build-up and or skiving of plastic (plastic flash) inside the distal tip of the Terumo Coronary Ostia Cannula. The defect was discovered during in-house inspection after Terumo CVS implemented a new inspection process for the cannula. There have been no reports of the defect in clinical use.

510(k) Number

K822210 ↗

FDA Product Code

DWF

Device Class

Class II

Regulation

21 CFR Part 870.4210

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• Clear Cardioplejia Delivery System

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See all devices from 3M Health Care, Sarns →