Multi-Track™ 615001Recalls & reported problems

Summary

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

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K952984); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 17, 2018Terminated

   Instructions for Use booklets were not included on the outer pouch

   Z-0510-2019 · Root cause: Labeling design · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K952984. One submission often covers many models, so check the product and lot details in each record.

• Z-0511-2019 · Oct 17, 2018 · Terminated
  Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA06100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers.