Proplege Coronary Sinus Catheter model PR9 — Class II medical device recall Z-1322-2013
Terminated recall by Edwards Lifesciences, LLC, reported 2013-05-22, distributed nationwide. Edwards Lifesciences is recalling certain Proplege Coronary Sinus Catheter, model PR9 due to confirmed reports
| Recall number | Z-1322-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Draper, UT, United States |
| Recall initiated | 2013-01-25 |
| Classified | 2013-05-14 |
| Reported by FDA | 2013-05-22 |
| Terminated | 2017-02-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 807 |
| Reason classes | packaging |
| Lot numbers | 59385159, 59385164, 59385204, 59398000, 59398006, 59398008, 59400402, 59423199, 59423200 |
| Model numbers | PR9 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1322-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.