AMICUS Exchange Kit - Therapeutics X6R2349Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

2 FDA recall records name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K180615); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Feb 14, 2023Class IIOpen, Classified

   Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator.

   Z-1255-2023 · Root cause: Process control · Recall details · FDA record ↗

2. Feb 25, 2021Class IITerminated

   Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols only. The defect is a blood leak at the boot, elbow, or in the channel on the separation chamber of the centrifuge pack.

   Z-1345-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K180615. One submission often covers many models, so check the product and lot details in each record.

• Z-1254-2023 · Feb 14, 2023 · Open, Classified
  Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform
• Z-1344-2021 · Feb 25, 2021 · Terminated
  Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.