Prelude SNAPRecalls & reported problems across all models
Merit Medical Systems, Inc. · 19 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one Prelude SNAP model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 33
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls
- 1
We found 19 models of Prelude SNAP by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between Nov 10, 2020 and May 8, 2026 — classified as 1 death, 32 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (11 reports).
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
Prelude SNAP 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.
- Jun 11, 2024Class IIOpen, Classified
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Z-2574-2024 · Root cause: No Marketing Application · names 17 of these models · Recall details · FDA record ↗
Most reported Prelude SNAP problems
Device problems
- Material Integrity Problem11
- Break10
- Fracture10
- Separation Failure8
- Activation, Positioning or Separation Problem6
- Difficult or Delayed Separation6
- Separation Problem5
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions30
- Hemothorax2
- Foreign Body In Patient1
Prelude SNAP models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Prelude SNAP™ 10884450467982INTRODUCER, CATHETER1 recall19 reports
- Prelude SNAP™ 10884450467951INTRODUCER, CATHETER1 recall6 reports
- Prelude SNAP™ 10884450467999INTRODUCER, CATHETER1 recall1 death2 reports
- Prelude SNAP™ 10884450468156INTRODUCER, CATHETER1 recall2 reports
- Prelude SNAP™ 10884450468019INTRODUCER, CATHETER1 recall0 reports
- Prelude SNAP™ 10884450468033INTRODUCER, CATHETER1 recall0 reports
- Prelude SNAP™ 10884450468040INTRODUCER, CATHETER1 recall0 reports
- Prelude SNAP™ 10884450468057INTRODUCER, CATHETER1 recall0 reports
- Prelude SNAP™ 10884450468064INTRODUCER, CATHETER1 recall0 reports
- Prelude SNAP™ 10884450468095INTRODUCER, CATHETER1 recall0 reports
- Prelude SNAP™ 10884450468118INTRODUCER, CATHETER1 recall0 reports
- Prelude SNAP™ 10884450468125INTRODUCER, CATHETER1 recall0 reports
- Prelude SNAP™ 10884450468132INTRODUCER, CATHETER1 recall0 reports
- Prelude SNAP™ 10884450489557INTRODUCER, CATHETER1 recall0 reports
- Prelude SNAP™ 10884450489564INTRODUCER, CATHETER1 recall0 reports
- Prelude SNAP™ 10884450489571INTRODUCER, CATHETER1 recall0 reports
- Prelude SNAP™ 10884450489595INTRODUCER, CATHETER1 recall0 reports
- Prelude SNAP™ TIntroducer, catheter3 reports
- Prelude SNAP™ TIntroducer, catheter1 report
Recent Prelude SNAP adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2026Device Fell
IT WAS REPORTED THAT DURING THE PROCEDURE WHEN REMOVING THE SHEATH, THE PLASTIC DISC FELL OFF INTO THE INSERTION SITE. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25127092 ↗MalfunctionNov 7, 2025Material Integrity Problem; Material Integrity Problem
THE ACCOUNT ALLEGES THE DEVICE FAILED TO SPLIT CORRECTLY. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23498059 ↗MalfunctionNov 5, 2025Material Integrity Problem; Material Integrity Problem
THE ACCOUNT ALLEGES WHEN ATTEMPTING TO SPLIT THE SHEATH THE VALVE WILL NOT SPLIT. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23480651 ↗MalfunctionOct 21, 2025Break; Fracture; Separation Failure; Activation, Positioning or Separation Problem; Material Integrity Problem; Separation Problem; Difficult or Delayed Separation; Break; Fracture; Separation Failure; Activation, Positioning or Separation Problem; Material Integrity Problem; Separation Problem; Difficult or Delayed Separation
THE ACCOUNT ALLEGES THAT WHEN SPLITTING THE SHEATH, ONE OF THE HANDLES BROKE OFF SO THE SHEAT COULD NOT BE PEELED ANYMORE. THE PROVIDER HAD TO CUT AND SLICE THE SHEATH BY HAND IN ORDER TO REMOVE THE SHEATH FROM THE IMPLANTED LEAD. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23351393 ↗MalfunctionOct 21, 2025Separation Failure; Activation, Positioning or Separation Problem; Separation Problem; Difficult or Delayed Separation; Separation Failure; Activation, Positioning or Separation Problem; Separation Problem; Difficult or Delayed Separation
THE ACCOUNT ALLEGES THAT THE SHEATH FAILED TO PEEL AFTER THE PROBE WAS INSERTED. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23349578 ↗MalfunctionOct 21, 2025Separation Failure; Activation, Positioning or Separation Problem; Separation Problem; Difficult or Delayed Separation; Separation Failure; Activation, Positioning or Separation Problem; Separation Problem; Difficult or Delayed Separation
THE ACCOUNT ALLEGES THAT THEY ARE UNABLE TO TEAR AWAY THE SPLITABLE SHEATH AT THE VALVE-RING. THE PROVIDER HAD TO CUT AND SLICE THE VALVE-RING BY HAND IN ORDER TO REMOVE THE SHEATH FROM THE IMPLANTED LEAD. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23349576 ↗MalfunctionOct 21, 2025Separation Failure; Activation, Positioning or Separation Problem; Separation Problem; Difficult or Delayed Separation; Separation Failure; Activation, Positioning or Separation Problem; Separation Problem; Difficult or Delayed Separation
THE ACCOUNT ALLEGES THAT THEY ARE UNABLE TO TEAR AWAY THE SPLITABLE SHEATH AT THE VALVE-RING. THE PROVIDER HAD TO CUT AND SLICE THE VALVE-RING BY HAND IN ORDER TO REMOVE THE SHEATH FROM THE IMPLANTED LEAD. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23349575 ↗MalfunctionOct 21, 2025Separation Failure; Activation, Positioning or Separation Problem; Separation Problem; Difficult or Delayed Separation; Separation Failure; Activation, Positioning or Separation Problem; Separation Problem; Difficult or Delayed Separation
THE ACCOUNT ALLEGES THAT THEY ARE UNABLE TO TEAR AWAY THE SPLITABLE SHEATH AT THE VALVE-RING. THE PROVIDER HAD TO CUT AND SLICE THE VALVE-RING BY HAND IN ORDER TO REMOVE THE SHEATH FROM THE IMPLANTED LEAD. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23349574 ↗MalfunctionSep 10, 2025Material Integrity Problem; Material Integrity Problem
CUSTOMER REPORTS HAVING A COUPLE OF PRELUDE SNAP SHEATHS NOT SPLITTING PROPERLY AND THE LITTLE VALVE IS FALLING OUT INTO THE PATIENT POCKET. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23017695 ↗MalfunctionAug 27, 2025Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem
THE ACCOUNT ALLEGES THAT THEY ARE UNABLE TO TEAR AWAY THE SPLITABLE SHEATH. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22909999 ↗MalfunctionAug 27, 2025Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem
THE ACCOUNT ALLEGES THAT THEY ARE UNABLE TO TEAR AWAY THE SPLITABLE SHEATH. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22909998 ↗MalfunctionAug 27, 2025Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem
THE ACCOUNT ALLEGES THAT THEY ARE UNABLE TO TEAR AWAY THE SPLITABLE SHEATH. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22909988 ↗MalfunctionAug 27, 2025Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem
THE ACCOUNT ALLEGES THAT THEY ARE UNABLE TO TEAR AWAY THE SPLITABLE SHEATH. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22909981 ↗MalfunctionAug 27, 2025Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem
THE ACCOUNT ALLEGES THAT THEY ARE UNABLE TO TEAR AWAY THE SPLITABLE SHEATH. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22909965 ↗MalfunctionJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2025, A MERIT EMPLOYEE CONDUCTED A PMCF REVIEW FOR THE PRELUDE SNAP PRODUCT FAMILY. A PRELUDE SNAP SPLITTABLE SHEATH INTRODUCER WAS USED TO TREAT A FEMALE PATIENT FOR THE INTRODUCTION OF SECONDARY DEVICE (E.G., PACING LEADS, CATHETERS) INTO THE HEART OR CORONARY VENOUS SYSTEM. THE PRIMARY USAGE OF THE DEVICE WAS TO FACILITATE PLACEMENT OF A DEVICE IN THE LEFT VENTRICLE THROUGH THE SUBCLAVIAN VEIN. THE DEVICE WAS USED FOR APPROXIMATELY 25 MINUTES. DURING THIS TIME THE PATIENT EXPERIENCED A PNEUMOTHORAX. NO ADDITIONAL TREATMENT WAS REQUIRED NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Hemothorax
MAUDE report 22647398 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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