Recall Z-2218-2024 ยท DYB Introducer, Catheter
Merit Medical Systems, Inc.
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 Sh
| Date | Jun 27, 2024 (initiated May 22, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| 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 |
| Quantity | 52,410 (updated 06/14/2024) |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211405 | Prelude Guide Sheath Merit Medical Systems, Inc., Oct 4, 2021 |