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Open, Classified

Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S -PG5F90S018 -PG6F45HS -PG6F45MP -PG6F45R -PG6F45S -PG6F45S018 -PG6F65MP -PG6F65S -PG6F65SX -PG6F90MP -PG6F90MPX -PG6F90SX -PG6F90SX018 -PG7F45MP -PG7F45MPX -PG7F45RX -PG7F45S -PG7F45SX -PG7F65SX -PG7F90SX -PG8F45MPX -PG8F45S -PG8F45SX -PG8F65SX -PG8F90SX -X9PG700001 The Prelude Guide Sheath Introducer is indicated to be used for the introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature.

FDA Recall Z-2218-2024 · Posted 2024-06-27

Recalling FirmMerit Medical Systems, Inc.
Recall StatusOpen, Classified
Product CodeDYB
Date Initiated2024-05-22
Product Quantity52,410 (updated 06/14/2024)

Reason for Recall

Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may cause users to over-tightening the luer which may result in the swivel nut detaching from the HVA body.

Firm Action

On 05/22/2024 and on 05/28/2024, the firm emailed an "URGENT MEDICAL DEVICE RECALL NOTICE" to customers informing them that the Instructions for Use (IFU) instructs users to "ensure that valve and the sheath are tightly connected before use" which may cause over-tightening of the luer fitting that may result in the swivel nut detaching from the Hemostasis valve adapter. Customers are instructed to: 1. Read and understand this letter and the IFU provided. There is no need to return product to Merit. 2. Post this notice and updated IFU on or near the affected products so users are aware of the recall. 3. Ensure that applicable personnel within your organization are made aware of this communication. 4. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice and updated IFU is immediately shared with them. Additional distribution details may be required by health authorities. 5. If you require paper IFUs, please contact [email protected]. 6. Please fill out, scan and email the completed Customer Response Form to Customer Service at [email protected] within 7 calendar days. If any questions - contact the Merit Sales Representative or Merit Customer Service via email at [email protected] or via phone at 801-208-4381 Hours: 6 am to 6 pm MST/Mon -Fri.

Root Cause

Device Design

Distribution Pattern

Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT. NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of Argentina, Brazil, Canada, Cayman Island, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Hong Kong, Republic of Korea, Mexico, New Zealand, Peru, South Africa, and Uruguay.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K211405Prelude Guide SheathMerit Medical Systems, Inc. · 2021-10-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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