Merit Medical cardiac kits contain plastic syringes with quality defects
Merit Medical convenience kits used in cardiac procedures contain plastic syringes with potential leaks and breakage. The defects were identified following an FDA Safety Alert issued March 19, 2024.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall. The syringes may have leaks or breakage in cardiac procedures, posing a risk to patient health. No illnesses or injuries have been reported. Per the rubric, recalls of risk-of-harm products without reported injuries score as High (3).
Plain-English summary
Merit Medical Systems, Inc. is recalling various Prelude SNAP Introducer Catheter kits that contain plastic syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd. These convenience kits are used to introduce pacing leads and catheters to the heart and coronary venous system. Approximately 55,305 units were distributed nationwide across all U.S. states.
The recalled syringes have been identified with leaks, breakage, and other quality issues that may pose a risk to patient health. These defects were identified in connection with an FDA Safety Alert issued on March 19, 2024.
Specific affected catalog numbers and lot numbers are provided in the FDA recall notice (Z-2574-2024). Healthcare providers with questions should contact Merit Medical Systems for further guidance and instructions.
The recalled product
- Product
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP (Introducer Catheter kit), REF: For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 55,305
Distribution
Part of a larger recall action
This product is one of 23 recalled by Merit Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 23 products in this recall →Related recalls
Same manufacturer · Merit Medical Systems, Inc.
See all →- ModerateMerit Medical Systems Recalls Scout MD Delivery Systems Due to Deployment Issues
FDA (Devices) · 2026-10-21
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- HighSplashwire hydrophilic guide wire pouches have unsealed portions
FDA (Devices) · 2026-06-24
- ModeratePhilips Bridge Prep Kit catheter may experience resistance during advancement
FDA (Devices) · 2026-05-06
- ModeratePhilips Bridge Prep Kit catheter may experience resistance during advancement
FDA (Devices) · 2026-05-06
Same hazard · leakage
See all →- SevereDraeger VentStar Resus Neo Neonatal Breathing Circuit Recall
FDA (Devices) · 2026-10-07
- HighConvaTec Esteem Body Soft Convex Urostomy Pouches Recalled for Leakage
FDA (Devices) · 2026-08-26
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
FDA (Devices) · 2026-08-05
- HighICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk
FDA (Devices) · 2026-07-29
Similar recalls
- HighMedline Medical Convenience Kits with Plastic Syringes Recalled Due to Leaks and Breakage
FDA (Devices) · 2024-09-18
- HighMedline Convenience Kits With Syringes Recalled for Quality Defects
FDA (Devices) · 2024-09-18
- HighCardinal Health Cardiac Catheterization Kits Recalled for Potential Syringe Design Defect
FDA (Devices) · 2024-07-17
- HighMedline Medical Convenience Kits Recalled Due to Syringe Quality Issues
FDA (Devices) · 2024-09-18
- HighConvenience kits recalled for containing defective medical syringes
FDA (Devices) · 2024-09-25
- HighMedline Medical Convenience Kits with Plastic Syringe Defects
FDA (Devices) · 2024-09-04