Prelude SNAP™ 10884450251567Recalls & reported problems
Merit Medical · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884450251567), received between Apr 17, 2020 and Apr 17, 2020 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Perforation of Vessels1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES THAT DURING A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IMPLANT PROCEDURE, THE PHYSICIAN EXPERIENCED SOME DIFFICULTY IN ACCESSING THE PATIENT'S SUBCLAVIAN VEIN. DURING SEVERAL ATTEMPTS TO ACCESS THE VEIN, BLEED BACK WAS VERIFIED BY THE ATTENDING PHYSICIAN. A VENOGRAM WAS TAKEN TO IDENTIFY THE TARGETED ANATOMY AND LANDMARKS WITH NO SUCCESS. THE PATIENT'S ARTERY WAS UNINTENTIONALLY PIERCED SEVERAL TIMES DURING ACCESS ATTEMPTS. THE PATIENT'S CONDITION DETERIORATED THROUGHOUT THE PROCEDURE AND THE ACCOUNT ALLEGES THAT THE PATIENT HAD TO BE INTUBATED, ARTIFICIALLY VENTILATED, RESUSCITATED AND TRANSFERRED TO A SURGICAL SUITE IN UNSTABLE CONDITION.
Patient problems: Perforation of Vessels
MAUDE report 9972582 ↗
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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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