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Medtronic Inc Recall 93258

Description: Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6

Medtronic Inc Recall 93258 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0321-2024
Event ID93258
Event DescriptionMedtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6
Product TypeDevices
DistributionWorldwide distribution - US Nationwide and the countries of Algeria, Armenia, France, Germany, Iraq, Italy, Japan, Netherlands, Poland, Romania, Spain, Sweden, Switzerland, United Kingdom.
Quantity173 units
Recall ReasonThe Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. These stickers label the common carotid artery (CCA) proximal balloon and external carotid artery (ECA) distal balloon inflation and deflation ports. Both sides of the complaint units manifold were labelled with the superior label leading to an incorrect identification of the proximal and distal inflation /deflation ports when viewing the devices from the inferior side.
Device Classification20231129
Device Code InfoUDI/DI 08033477090702:
Center Classification Date20231117
Recall Initiation Date20231012
Recalling FirmMedtronic Inc
Initial Notification Letter
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