Merit Medical Recalls Prelude SNAP Splittable Sheath Introducers
Merit Medical Systems is voluntarily recalling specific lots of Prelude SNAP Splittable Sheath Introducers due to an intermittent failure of the splittable hub.
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: The recall involves a medical device with a functional defect (intermittent failure of the splittable hub) which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Merit Medical Systems, Inc. is voluntarily conducting a recall of specific lots of Prelude SNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers. The recall involves 60,945 devices with various catalog numbers, including PLS-1007, PLS-1008, and PLS-1009.
The reason for the recall is an intermittent failure of the splittable hub. The affected devices were distributed in the US, Australia, the EU, Serbia, Israel, Malaysia, South Africa, and Bahrain. Specific lot numbers are listed in the official recall documentation.
Healthcare providers and facilities should check their inventory for the affected catalog numbers and lot numbers. Users should stop using the affected devices and contact Merit Medical Systems for instructions on how to return or dispose of them.
The recalled product
- Product
- PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007, PLS-1008, PLS-1009, PLS-1009.5, PLS-1010, PLS-1010.5, PLS-1011, PLS-2506, PLS-2507, PLS-2508, PLS-2509, PLS-2510, PLS-2510.5, PLSH-1006, PLSH-1009, PLSX-1006, PLSX-1007…
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Introducers
- Hazard
- Affected units
- 60,945
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Merit Medical Systems, Inc.
See all →- 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
- ModeratePhilips Bridge Prep Kit catheter may experience resistance during advancement
FDA (Devices) · 2026-05-06
Same hazard · functional failure
See all →- ModerateOlympus DisplayPort Cable Recalled for Video Dropout Risk
FDA (Devices) · 2026-10-07
- HighAccuVu Angiographic Catheter, Omni Flush, Non-Braided Defect Recall
FDA (Devices) · 2026-04-29
- HighBaxter TruSystem 7500 Hybrid software issue disables upper back adjustment
FDA (Devices) · 2025-04-02
- HighSoftware Malfunction Disables Back Control on Baxter TruSystem 7500
FDA (Devices) · 2025-04-02
- SevereCardiac catheters recalled due to polyurethane layer delamination defects
FDA (Devices) · 2024-05-22
Similar recalls
- HighCardiac Sheath Introducer Devices Recalled Due to Size Mislabeling
FDA (Devices) · 2021-08-18
- HighPrelude SNAP cardiac introducer sheath potentially mislabeled with wrong size
FDA (Devices) · 2021-08-18
- HighMerit Medical Prelude Introducer Sheath Recalled for Incorrect Dilator
FDA (Devices) · 2021-08-18
- SevereMerit Medical Recalls 7F Prelude Short Sheath Introducers Due to Detachment Risk
FDA (Devices) · 2017-04-05
- HighMerit Medical Cardiac Catheter Kits Recalled for Syringe Leaks and Breakage
FDA (Devices) · 2024-08-21
- HighPrelude Sheath Introducer 7.5F devices recalled due to labeling error
FDA (Devices) · 2024-10-02