PreludeSYNC™ 10884450363659Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
All models of PreludeSYNC (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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.
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 16, 2026.
Recalls naming this device
- Mar 11, 2020Terminated
During the sterilization of radial compression devices, some of the inflatable balloons may break or burst, which may result in air leakage and the inability to maintain pressure/compression. This may result in a lack of hemostasis resulting in bleeding or a delay in treatment; the defect is likely to be visually identified by the clinician before use or identified during inflation of the balloon.
Z-1796-2020 · Root cause: Other · Recall details · FDA record ↗
Other CLAMP, VASCULAR devices
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- Heartstring III System 4.3MM HSK-3043Maquet Cardiovascular LLC · Clamp, Vascular1 recall265 reports
- TR BAND TRB24-REGTerumo Medical Corporation · CLAMP, VASCULAR284 reports
- TR BAND TRB24-REGTerumo Medical Corporation · CLAMP, VASCULAR256 reports
- HeartString III Proximal Seal HS-3045Maquet Cardiovascular LLC · Clamp, Vascular1 recall187 reports
- TR BAND TRB29-LRGTerumo Medical Corporation · CLAMP, VASCULAR67 reports
- TR BAND TRB29-LRGTerumo Medical Corporation · CLAMP, VASCULAR65 reports
- Flo-Thru Intraluminal Shunt® FT-12125Synovis Life Technologies, Inc. · CLAMP, VASCULAR1 recall1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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