Medtronic Perfusion Systems: Medical Device Recall in 2017 - (Recall #: Z-2764-2017)

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 Extension Line Adapters 20 in length Used to extend cardioplegia line during cardiopulmonary bypass surgery

Product Classification:

Class II

Date Initiated: June 22, 2017
Date Posted: August 2, 2017
Recall Number: Z-2764-2017
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. 11001G; Product UPN 20613994918554; Lot No. 2016020769, 2016030796, 2016040778, 2016060872, 2016061425, 2016070500, 2016081190, 2016090516, 2016091016, 2016110504, 2016120414, 2017010236, 2017011281, 2017030506.

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