OutakeRecalls & reported problems across all models

We found 2 models of Outake by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Outake recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 11, 2024Open, Classified

   Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

   Z-2559-2024 · Root cause: No Marketing Application · names 2 of these models · Recall details · FDA record ↗

Outake models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Outake® 00884450045497

  Tunneled catheter remover
  1 recall0 reports
• Outake® 00884450052587

  Tunneled catheter remover
  1 recall0 reports

Other Merit Medical Systems, Inc. products

• Aspira11 models · 36 reports · 10 recalls
• Impress145 models · 481 reports
• Monarch6 models · 37 reports · 7 recalls
• Bridge Prep Kit4 models · 6 reports · 3 recalls
• Prelude Roadster33 models · 1 reports · 3 recalls
• basixTOUCH6 models · 1 reports · 3 recalls
• basixCOMPAK34 models · 34 reports · 2 recalls
• Flex-Neck11 models · 21 reports · 2 recalls