The Recall Desk
HighFDA (Devices)·Z-1497-2017·Announced 2017-04-05

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.

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: The recall involves a medical device with a risk of harm (detachment during use) where no injuries have been reported, which aligns with the 'High' severity criteria for risk-of-harm products without reported injury.

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 art
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.

Related recalls

Same manufacturer · Merit Medical Systems, Inc.

See all →

Same hazard · component detachment

See all →