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.
FDA Recall Z-1322-2013 · Posted 2013-05-14
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Recalling FirmEdwards Lifesciences, LLC
Recall StatusTerminated
Product CodeDWF
Date Initiated2013-01-25
Date Terminated2017-02-16
Product Quantity807
Reason for Recall
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.
Firm Action
Edwards Lifesciences sent an Urgent Field Safety Notice letter dated February 1, 2013. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review entire inventory for the affected product, quarantine and return to Edwards. Contact Customer Services at 800-424-3278 for any question, to obtain a Returned Goods Authorization number and replacement product.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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