DiamondTOUCH™Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's 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, 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
- Aug 4, 2025Open, Classified
Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.
Z-0533-2026 · Root cause: Process change control · FDA record ↗
Other Syringe, balloon inflation devices
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- Indeflator 1000186-115Abbott Vascular Inc. · Syringe, balloon inflation2 recalls124 reports
- Alliance II M00550600Boston Scientific Corporation · Syringe, balloon inflation191 reports
- Indeflator 1000185Abbott Vascular Inc. · Syringe, balloon inflation1 recall131 reports
- Indeflator 1000186Abbott Vascular Inc. · Syringe, balloon inflation2 recalls56 reports
- Encore™ 26 M001151050Boston Scientific Corporation · Syringe, balloon inflation1 recall54 reports
- PRESTO ID4030Bard Peripheral Vascular, Inc. · Syringe, balloon inflation1 death98 reports
- Encore™ 26 Advantage Kit H74904527011Boston Scientific Corporation · Syringe, balloon inflation1 recall28 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.