Merit Medical Cardiac Catheter Kits Recalled for Syringe Leaks and Breakage
Merit Medical's Prelude SNAP-H cardiac catheter kits are being recalled because their syringes may leak or break during use, potentially affecting cardiac procedures. No illnesses have been reported.
What this means for you
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 an FDA Class II recall of high-risk cardiac catheter kits with identified quality defects (leaks and breakage) that may pose patient risk. No illnesses or injuries have been reported, classifying this as a risk-of-harm product without documented harm.
Plain-English summary
Merit Medical Systems is recalling 745 Prelude SNAP-H Introducer Catheter kits distributed nationwide. These kits contain syringes manufactured by Jiangsu Shenli Medical Production Co. Ltd. that were subject to an FDA Safety Alert issued March 19, 2024.
The recalled syringes have been identified with quality issues including leaks and breakage. These problems could pose risks during cardiac procedures where the kits are used to introduce pacing leads and catheters into the heart and coronary venous system.
The affected kits were distributed nationwide across all U.S. states. Specific catalog numbers and lot information has been provided to healthcare facilities to help identify the recalled products.
Healthcare providers and facilities that have received these kits should stop using them and contact Merit Medical for further instructions. Patients who have had procedures using these kits should consult their healthcare provider if they have questions or concerns.
The recalled product
- Product
- Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP-H (Introducer Catheter kit), REF: PLSH-1006/A PLSH-1007/A PLSH-1008/A PLSH-1009.5/A PLSH-2506/A PLSH-2507/A For the introduction of various t
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 745
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.
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