10ForeRecalls & reported problems across all models
Merit Medical Systems, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one 10Fore model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 2 models of 10Fore by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Sep 16, 2026 and Sep 16, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Air/Gas in Device” (1 report).
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
Reports received per month, all models
10Fore 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.
- Jul 25, 2025Open, Classified
Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway.
Z-2553-2025 · Root cause: Employee error · names 2 of these models · Recall details · FDA record ↗
Most reported 10Fore problems
Device problems
- Air/Gas in Device1
Patient problems
- Cardiac Arrest1
10Fore models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 10Fore™ Initial ReleaseAngiography/Angioplasty Kit1 recall1 report
- 10Fore™ Initial ReleaseAdaptor, stopcock, manifold, fitting, cardiopulmonary bypass1 recall0 reports
Recent 10Fore adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 16, 2026Air/Gas in Device
Patient problems: Cardiac Arrest
MAUDE report 50794590 ↗
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
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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