Medtronic Inc. Cardiac Rhythm Disease Management recalls Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass procedures. Model number

Recalled March 13, 2013 · FDA recall Z-0908-2013 · Medtronic Inc. Cardiac Rhythm Disease Management

Hazard

Potential for uncharacteristically rough metal edges to occur along the inner diameter of the metal tip side ports of the cannula. · FDA Class II

Units

13,691 (6711 USA; 6980 OUS)

Sold at

Worldwide distribution, including USA nationwide, Albania, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Korea, Libya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Viet Nam.

Description

Potential for uncharacteristically rough metal edges to occur along the inner diameter of the metal tip side ports of the cannula.

Product

Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass procedures. Model numbers: 67312; 67314; CB67314; 67316; 67318; CB67318; 67320; 69312; 69314; 69316; 69318; 69320; 69322; 69324; 69328; 69331.

Manufacturer(s)

Medtronic Inc. Cardiac Rhythm Disease Management

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →