There is a potential risk of packaging damage for introducer kits which may compromise the sterile barrier. There have been no reported complaints for this type of damage and this issue was found in <0.6% of all introducer kits that was received. The following introducer kit identifiers, 0052-3006, 0052-3046, 0052-3014, 0052-3025, 0052-3052 which are part of the Impella pump sets and insertion kits are affected by the recall action. Recall Start Date: December 11, 2023
RecallTracker