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Edwards Lifesciences, LLC recalls Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9. Product Usage: The catheter intro
Recalled May 22, 2013 · FDA recall Z-1322-2013 · Edwards Lifesciences
Hazard
Edwards Lifesciences is recalling certain Proplege Coronary Sinus Catheter, model PR9 due to confirmed reports of blood leakage through the hemostasis valve in the introducer that is kitted with the catheter. · FDA Class II
Units
807
Sold at
Worldwide Distribution - USA Nationwide including the states of: MD, NY, PA, CA, FL, AZ, AL, TX, VA, OH, MO, NC, GA, TN, CO, OR, SC, ME, IL, HI, NJ, WA, WI, CT, KY, LA and Canada.
Description
Edwards Lifesciences is recalling certain Proplege Coronary Sinus Catheter, model PR9 due to confirmed reports of blood leakage through the hemostasis valve in the introducer that is kitted with the catheter.
Product
Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9. Product Usage: The catheter introducer sheath kit provides access to the central venous circulation to facilitate catheter and guidewire insertion. The Proplege coronary sinus catheter provides retrograde cardioplegia during cardiopulmonary by-pass surgery.
Manufacturer(s)
Edwards Lifesciences, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →