Medtronic Perfusion Systems: Medical Device Recall in 2017 - (Recall #: Z-2766-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 22, 2017

Date Posted: August 2, 2017

Recall Number: Z-2766-2017

Event ID: 77641

Reason for Recall:

Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.

Status: Terminated

Product Quantity: 63053 (48180 US) (14873 OUS)

Code Information:

Model No. 15004; Product UPN 20613994900412; Lot No. 2016031072, 2016031509, 2016050243, 2016081219, 2016100630, 2016120083, 2016120448, 2017040113.

Distribution Pattern:

Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Denmark, El Salvador, France, Georgia, Germany, Hungary, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Macedonia, Moldova, Netherlands, New Zealand, Nigeria, Norway, Poland, Romania, Russian Federation, Slovenia, Spain, Thailand, Turkey, & United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated