Proplege Coronary Sinus Catheter model PR9, 11 French… recallZ-1322-2013 · Edwards Lifesciences, LLC · initiated Jan 25, 2013
Class II Terminated All recalls posted in May 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Edwards Lifesciences, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1322-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jan 25, 2013
- Posted by the FDA
- May 14, 2013
- Recalling firm
- Edwards Lifesciences, LLC
- Quantity
- 807
- Product code
- DWF
- FDA submissions
- K120780
- Distribution
- 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.
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.
Code information (models, lots, serial numbers)
Model PR9, lot numbers: 59385159, 59385164, 59385204, 59398000, 59398006, 59398008, 59400402, 59423199, 59423200, 59385159, 59385164, 59385204, 59398000, 59398006.
Other devices under the same FDA submission
1 device cleared under K120780 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- enableCV ProPlege Peripheral Retrograde Cardioplegia Device PR9Enablecv Inc. · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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