PreludeSYNC EVO™ 10884450567873Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884450567873), received between May 8, 2025 and May 8, 2025 — classified as 6 injuries.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem6
Patient problems
- Hematoma6
- Pseudoaneurysm6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES THAT THEY EXPERIENCED ISSUES WHEN USING THE SYNC EVO BAND, RESULTING IN SEVERAL HEMATOMAS THAT LED TO PSEUDOANEURYSMS THAT REQUIRED SURGICAL INTERVENTION TO REPAIR. THE PHYSICIAN WAS NOT SURE HOW THE EVO BAND CONTRIBUTED TO THE PATIENT'S INJURY BUT DID CONFIRM THAT THEY ARE USING THE STAT SEAL PRODUCT ON ALL RADIAL PROCEDURES WITH 1 HOUR RECOVERY TIMES ALONG WITH THE SYNC EVO BAND.
Patient problems: Hematoma; Pseudoaneurysm
MAUDE report 21989452 ↗InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES THAT THEY EXPERIENCED ISSUES WHEN USING THE SYNC EVO BAND, RESULTING IN SEVERAL HEMATOMAS THAT LED TO PSEUDOANEURYSMS THAT REQUIRED SURGICAL INTERVENTION TO REPAIR. THE PHYSICIAN WAS NOT SURE HOW THE EVO BAND CONTRIBUTED TO THE PATIENT'S INJURY BUT DID CONFIRM THAT THEY ARE USING THE STAT SEAL PRODUCT ON ALL RADIAL PROCEDURES WITH 1 HOUR RECOVERY TIMES ALONG WITH THE SYNC EVO BAND.
Patient problems: Hematoma; Pseudoaneurysm
MAUDE report 21989451 ↗InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES THAT THEY EXPERIENCED ISSUES WHEN USING THE SYNC EVO BAND, RESULTING IN SEVERAL HEMATOMAS THAT LED TO PSEUDOANEURYSMS THAT REQUIRED SURGICAL INTERVENTION TO REPAIR. THE PHYSICIAN WAS NOT SURE HOW THE EVO BAND CONTRIBUTED TO THE PATIENT'S INJURY BUT DID CONFIRM THAT THEY ARE USING THE STAT SEAL PRODUCT ON ALL RADIAL PROCEDURES WITH 1 HOUR RECOVERY TIMES ALONG WITH THE SYNC EVO BAND.
Patient problems: Hematoma; Pseudoaneurysm
MAUDE report 21989441 ↗InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES THAT THEY EXPERIENCED ISSUES WHEN USING THE SYNC EVO BAND, RESULTING IN SEVERAL HEMATOMAS THAT LED TO PSEUDOANEURYSMS THAT REQUIRED SURGICAL INTERVENTION TO REPAIR. THE PHYSICIAN WAS NOT SURE HOW THE EVO BAND CONTRIBUTED TO THE PATIENT'S INJURY BUT DID CONFIRM THAT THEY ARE USING THE STAT SEAL PRODUCT ON ALL RADIAL PROCEDURES WITH 1 HOUR RECOVERY TIMES ALONG WITH THE SYNC EVO BAND.
Patient problems: Hematoma; Pseudoaneurysm
MAUDE report 21984390 ↗InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES THAT THEY EXPERIENCED ISSUES WHEN USING THE SYNC EVO BAND, RESULTING IN SEVERAL HEMATOMAS THAT LED TO PSEUDOANEURYSMS THAT REQUIRED SURGICAL INTERVENTION TO REPAIR. THE PHYSICIAN WAS NOT SURE HOW THE EVO BAND CONTRIBUTED TO THE PATIENT'S INJURY BUT DID CONFIRM THAT THEY ARE USING THE STAT SEAL PRODUCT ON ALL RADIAL PROCEDURES WITH 1 HOUR RECOVERY TIMES ALONG WITH THE SYNC EVO BAND.
Patient problems: Hematoma; Pseudoaneurysm
MAUDE report 21984389 ↗InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES THAT THEY EXPERIENCED ISSUES WHEN USING THE SYNC EVO BAND, RESULTING IN SEVERAL HEMATOMAS THAT LED TO PSEUDOANEURYSMS THAT REQUIRED SURGICAL INTERVENTION TO REPAIR. THE PHYSICIAN WAS NOT SURE HOW THE EVO BAND CONTRIBUTED TO THE PATIENT'S INJURY BUT DID CONFIRM THAT THEY ARE USING THE STAT SEAL PRODUCT ON ALL RADIAL PROCEDURES WITH 1 HOUR RECOVERY TIMES ALONG WITH THE SYNC EVO BAND.
Patient problems: Hematoma; Pseudoaneurysm
MAUDE report 21984388 ↗
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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 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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