CLASS II Device recall · Reported 22 May 2013 · FDA Enforcement Report

Proplege Coronary Sinus Catheter recalled by Edwards Lifesciences

Edwards Lifesciences is recalling Proplege Coronary Sinus Catheter, distributed nationwide in the US. The recall was initiated on 25 Jan 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel PR9, lot numbers: 59385159, 59385164, 59385204, 59398000, 59398006, 59398008, 59400402, 59423199, 59423200, 59385159, 59385164, 59385204, 59398000, 59398006.

Quantity recalled807

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1322-2013
FDA event ID: 64221
Recalling firm: Edwards Lifesciences, Draper, UT
Classification: Class II
Status: Terminated
Recall initiated: 25 Jan 2013
FDA classified: 14 May 2013
Reported: 22 May 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

25 Jan 2013	Recall initiated by company
14 May 2013	Classified by FDA	+109 days
22 May 2013	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Alabama Arizona California Colorado Connecticut Florida Georgia Hawaii Illinois Kentucky Louisiana Maryland Maine Missouri North Carolina New Jersey New York Ohio Oregon Pennsylvania

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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16 Jul 2025Device	CLASS I	Fem-flexii Femoral Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide
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16 Jul 2025Device	CLASS I	Fem-flex II Femoral Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide

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