FDA Device recall Z-1322-2013
Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9. Product Usage: The catheter introducer sheath kit provid…
- FDA Device
- Class II
- terminated
- Published 2013-05-22
On 2013-05-22 the FDA classified a Class II recall of Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9. Product Usage: The catheter introducer sheath kit provid… by Edwards Lifesciences, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1322-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-01-25 |
| Published | 2013-05-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Edwards Lifesciences |
| Distribution | US |
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
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.
Identifiers
| code_info | Model PR9, lot numbers: 59385159, 59385164, 59385204, 59398000, 59398006, 59398008, 59400402, 59423199, 59423200, 59385…Model PR9, lot numbers: 59385159, 59385164, 59385204, 59398000, 59398006, 59398008, 59400402, 59423199, 59423200, 59385159, 59385164, 59385204, 59398000, 59398006. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1322-2013%22
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