FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc.: 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
- Recall number
- Z-0949-2017
- Recalling firm
- Merit Medical Systems, Inc.
- Product
- 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
- Status
- Terminated
- Initiated
- 2016-12-01
- Posted
- 2017-01-05
- Terminated
- 2017-04-18
- Reason
- 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.
- Root cause
- Process change control
- Action
- Merit Medical sent an Urgent Product Recall Notice dated December 1, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to identify any affected devices within their facility, quarantine them, and discontinue use. Ensure that all personnel to whom the devices were distributed are made aware of this field action. Consignees were asked to work with their Merit Sales Representative to arrange product return. Consignees with questions were instructed to contact their Merit Sales Representative or Merit Customer Service at response@merit.com or at 801-208-4381. For questions regarding this recall call 801-208-4623.
- Quantity
- 335
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Lots: H1014678, H1039272, H1029150, H1039269, H1029151
- 510(k) numbers
- ["K140543"]
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 1721504
- Firm city
- South Jordan
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28