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Recall Observatory FDA recall evidence

Device product

DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.

Z-2767-2017

June 22, 2017

Class II

Product summary

Firm
Medtronic Perfusion Systems
Event
Event 77641
Status
Terminated
Classification
Class II
Quantity
63053 (48180 US) (14873 OUS)
Official record key
device-enforcement:Z-2767-2017

Official wording

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

Code information: Model No. 25009; Product UPN 20613994918608; Lot No. 2016090217, 2016091068, 2016100893, 2016110439, 2016120464, 2017010278, 2017030102, 2017030576, 2017031125. Model No. 25010: Product UPN 20613994918585: Lot No. 2016020841, 2016031522, 2016050255, 2016070494, 2016081243, 2016090923, 2016110054, 2016110837, 2017040714.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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