Merit Medical Systems, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0949-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The access needle with inner metal needle and outer plastic cannula is used to gain access to the vein or artery for placement of guide wires

Product Classification:

Class II

Date Initiated: December 1, 2016

Date Posted: January 11, 2017

Recall Number: Z-0949-2017

Event ID: 75999

Reason for Recall:

Recalling dilators included with the 6F PreludeEASE Hydrophilic Sheath Introducer because the dilator tips were manufactured with an undersized inner diameter and therefore will not allow passage of an 0.021 (0.53 mm) guide wire.

Status: Terminated

Product Quantity: 335

Code Information:

Lots: H1014678, H1039272, H1029150, H1039269, H1029151

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated