Merit Medical Recalls 7F Prelude Short Sheath Introducers Due to Detachment Risk
Merit Medical Systems is voluntarily recalling 1,265 units of 7F Prelude Short Sheath Introducers because the sheath marker tips may detach during use.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Merit Medical Systems, Inc. announces a voluntary field action for sheaths included with the 7F Prelude¿ Short Sheath Introducers because the sheath marker tips may detach during use."
Plain-English summary
Merit Medical Systems, Inc. is conducting a voluntary field action for 1,265 units of the 7F Prelude Short Sheath Introducer. The recall is initiated because the sheath marker tips on these devices may detach during use. The affected catalog numbers are K15-00070, K15-00170, PSS-7F-4-035MT, and PSS-7F-4MT.
The 7F Prelude Short Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for diagnostic and therapeutic procedures. It can also provide access to native or synthetic grafts used for hemodialysis. The device is not indicated for long-term vascular or hemodialysis access.
The affected lots are H1041469, H1041473, H1036880, and H1041464. These products were distributed nationwide and to other foreign consignees. The source text does not specify any reported injuries or illnesses associated with this defect.
The recalled product
- Product
- 7F Prelude¿ Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc Usage: The Merit Prelude¿ Short Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or…
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Vascular Access
- Hazard
- Affected units
- 1,265
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot Numbers: H1041469
- H1041473
- H1036880
- H1041464.
Distribution
Distributed nationwide across the United States.
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