Edwards Lifesciences, LLC: Medical Device Recall in 2013 - (Recall #: Z-1322-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 25, 2013

Date Posted: May 22, 2013

Recall Number: Z-1322-2013

Event ID: 64221

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.

Status: Terminated

Product Quantity: 807

Code Information:

Model PR9, lot numbers: 59385159, 59385164, 59385204, 59398000, 59398006, 59398008, 59400402, 59423199, 59423200, 59385159, 59385164, 59385204, 59398000, 59398006.

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.

Voluntary or Mandated:

Voluntary: Firm initiated