Z-1322-2013Class II

Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9

Name: Z-1322-2013 Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9
Creator: Edwards Lifesciences, LLC
Published: 2013-01-25
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2013-01-25 / Terminated / root cause: design

FDA source

Edwards Lifesciences, LLC began a recall of Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9. Product Usage: The catheter introducer sheath kit provides access to the... on 2013-01-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1322-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-25
Posted: 2013-05-14
Terminated: 2017-02-16
Recalling firm: Edwards Lifesciences LLC
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.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 807
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 codes and lots: Model PR9, lot numbers: 59385159, 59385164, 59385204, 59398000, 59398006, 59398008, 59400402, 59423199, 59423200, 59385159, 59385164, 59385204, 59398000, 59398006.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1322-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1322-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-14

Product code DWF

K120780Class IIEdward Proplege Peripheral Retrograde Cardioplegia DeviceEdwards Lifesciences, LLC / cleared 2012-06-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)