FDA Device recall Z-2766-2017
DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure monitoring needle near the connection to the cardioplegia cannula
- FDA Device
- Class II
- terminated
- Published 2017-08-02
On 2017-08-02 the FDA classified a Class II recall of DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure monitoring needle near the connection to the cardioplegia cannula by Medtronic Perfusion Systems, citing identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2766-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-22 |
| Published | 2017-08-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Perfusion Systems |
| Distribution | US |
Product
DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure monitoring needle near the connection to the cardioplegia cannula. These adapters are intended for use in conjunction with the delivery of cardioplegia solution and to provide access for pressure monitoring for up to six hours
Reason
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
Identifiers
| code_info | Model No. 15004; Product UPN 20613994900412; Lot No. 2016031072, 2016031509, 2016050243, 2016081219, 2016100630, 2016120083, 2016120448, 2017040113. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2766-2017%22
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