Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Prelude Roadster Guide Sheath

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Prelude Roadster Guide Sheathsee related information
Date Initiated by FirmMay 22, 2024
Date PostedJune 27, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2218-2024
Recall Event ID 94684
510(K)NumberK211405 
Product Classification Introducer, catheter - Product Code DYB
ProductPrelude 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.
Code Information Catalog Code/Lot Number/UDI-DI PG4F45S H2409286 00884450531709 H2511381 00884450531709 H2532402 00884450531709 H2542733 00884450531709 H2602038 00884450531709 H2613452 00884450531709 H2655892 00884450531709 H2668983 00884450531709 H2684566 00884450531709 H2800559 00884450531709 H2808568 00884450531709 H2817152 00884450531709 H2830841 00884450531709 H2839229 00884450531709 H2852688 00884450531709 PG4F90S H2418703 00884450531716 H2478781 00884450531716 H2532524 00884450531716 H2542736 00884450531716 H2642436 00884450531716 H2662245 00884450531716 H2668984 00884450531716 H2684572 00884450531716 H2757247 00884450531716 H2763317 00884450531716 H2876572 00884450531716 PG5F45MP H2409290 00884450531914 H2478782 00884450531914 H2542737 00884450531914 H2633727 00884450531914 H2655894 00884450531914 H2662249 00884450531914 H2684571 00884450531914 H2722066 00884450531914 H2757249 00884450531914 H2777503 00884450531914 H2785759 00884450531914 H2821571 00884450531914 H2830842 00884450531914 PG5F45R H2418694 00884450531921 H2474337 00884450531921 H2532525 00884450531921 H2569083 00884450531921 H2684579 00884450531921 H2722072 00884450531921 H2757250 00884450531921 H2785760 00884450531921 H2800565 H2918260 PG5F45S H2412933 00884450531730 H2418701 00884450531730 H2460087 00884450531730 H2510831 00884450531730 H2542738 00884450531730 H2589671 00884450531730 H2598840 00884450531730 H2633728 00884450531730 H2652758 00884450531730 H2655895 00884450531730 H2673477 00884450531730 H2684561 00884450531730 H2748336 00884450531730 H2757252 00884450531730 H2785761 00884450531730 H2813084 00884450531730 H2821574 00884450531730 H2830844 00884450531730 H2839234 00884450531730 H2852691 00884450531730 H2862025 00884450531730 H2877519 00884450531730 H2892964 PG5F45S018 H2748630 00884450770757 H2757274 00884450770757 H2800643 00884450770757 H2830864 00884450770757 H2843966 00884450770757 PG5F90MP H2426296 00884450531952 H2478800 00884450531952 H2532526 00884450531952 H2792291 00884450531952 H2800566 00884450531952 PG5F90S H2409297 00884450531945 H2504194 00884450531945 H2542744 00884450531945 H2569086 00884450531945 H2598841 00884450531945 H2626371 00884450531945 H2662254 00884450531945 H2668986 00884450531945 H2684573 00884450531945 H2722078 00884450531945 H2757253 00884450531945 H2763268 00884450531945 H2777539 00884450531945 H2785763 00884450531945 H2800567 00884450531945 H2800568 00884450531945 H2839241 00884450531945 H2872518 00884450531945 H2887808 00884450531945 H2897442 00884450531945 PG5F90S018 H2748631 00884450770764 H2757275 00884450770764 PG6F45HS H2409312 00884450557501 H2511383 00884450557501 H2516396 00884450557501 H2542789 00884450557501 H2722076 00884450557501 H2830863 00884450557501 H2862773 00884450557501 PG6F45MP H2409315 00884450532065 H2460158 00884450532065 H2542749 00884450532065 H2589642 00884450532065 H2613479 00884450532065 H2613485 00884450532065 H2648624 00884450532065 H2652755 00884450532065 H2662277 00884450532065 H2673493 00884450532065 H2785774 00884450532065 H2830852 00884450532065 H2839244 00884450532065 H2849299 00884450532065 H2897440 00884450532065 PG6F45R H2409322 00884450532133 H2460159 00884450532133 H2474360 00884450532133 H2542752 00884450532133 H2626382 00884450532133 H2648626 00884450532133 H2662278 00884450532133 H2748573 00884450532133 H2777544 00884450532133 H2785776 00884450532133 H2800575 00884450532133 H2830853 00884450532133 H2843960 00884450532133 H2862729 00884450532133 H2872520 00884450532133 H2887812 00884450532133 H2908171 H2918266 PG6F45S H2405182 00884450531969 H2418685 00884450531969 H2425355 00884450531969 H2460116 00884450531969 H2510837 00884450531969 H2532527 00884450531969 H2542746 00884450531969 H2552118 00884450531969 H2552119 00884450531969 H2562918 00884450531969 H2562919 00884450531969 H2563291 00884450531969 H2563292 00884450531969 H2589672 00884450531969 H2598849 00884450531969 H2598851 00884450531969 H2613453 00884450531969 H2613454 00884450531969 H2613455 00884450531969 H2613456 00884450531969 H2643176 00884450531969 H2648649 00884450531969 H2652759 00884450531969 H2652760 00884450531969 H2655896 00884450531969 H2662275 00884450531969 H2662348 00884450531969 H2662349 00884450531969 H2669001 00884450531969 H2673484 00884450531969 H2684536 00884450531969 H2684537 00884450531969 H2684538 00884450531969 H2748337 00884450531969 H2757262 00884450531969 H2763269 00884450531969 H2777541 00884450531969 H2785765 00884450531969 H2785768 00884450531969 H2792292 00884450531969 H2800570 00884450531969 H2800571 00884450531969 H2800572 00884450531969 H2800573 00884450531969 H2821576 00884450531969 H2830845 00884450531969 H2830850 00884450531969 H2839242 00884450531969 H2839243 00884450531969 H2849298 00884450531969 H2857612 00884450531969 H2862028 00884450531969 H2862029 00884450531969 H2868435 00884450531969 H2868436 00884450531969 H2872519 00884450531969 H2877521 00884450531969 H2877558 00884450531969 H2887810 00884450531969 H2908166 00884450531969 PG6F45S018 H2748634 00884450770771 H2757276 00884450770771 H2817178 00884450770771 H2887828 00884450770771 H2902031 PG6F65MP H2409330 00884450532157 H2516377 00884450532157 H2542755 00884450532157 H2589669 00884450532157 H2613493 00884450532157 H2662280 00884450532157 H2728383 00884450532157 H2785779 00884450532157 H2792297 00884450532157 H2821580 00884450532157 H2852704 00884450532157 PG6F65S H2409329 00884450532140 H2460160 00884450532140 H2510834 00884450532140 H2532529 00884450532140 H2542757 00884450532140 H2569143 00884450532140 H2613495 00884450532140 H2633736 00884450532140 H2655898 00884450532140 H2662282 00884450532140 H2669077 00884450532140 H2684562 00884450532140 H2738817 00884450532140 H2748579 00884450532140 H2757263 00884450532140 H2777546 00884450532140 H2785782 00884450532140 H2785784 00884450532140 H2800576 00884450532140 H2800577 00884450532140 H2849300 00884450532140 H2872522 00884450532140 H2887816 00884450532140 H2897439 00884450532140 H2901961 00884450532140 H2908177 00884450532140 PG6F65SX H2409342 00884450532164 H2460161 00884450532164 H2542760 00884450532164 H2552519 00884450532164 H2589670 00884450532164 H2598855 00884450532164 H2613496 00884450532164 H2626390 00884450532164 H2642441 00884450532164 H2652756 00884450532164 H2655899 00884450532164 H2662283 00884450532164 H2684559 00884450532164 H2684560 00884450532164 H2748338 00884450532164 H2757264 00884450532164 H2777547 00884450532164 H2785792 00884450532164 H2792299 00884450532164 H2800579 00884450532164 H2868537 00884450532164 H2887817 00884450532164 H2891965 00884450532164 H2897299 00884450532164 PG6F90MP H2409335 00884450532171 H2516378 00884450532171 H2542761 00884450532171 H2598885 00884450532171 H2648627 00884450532171 H2684575 00884450532171 H2763272 00884450532171 H2785797 00884450532171 H2800580 00884450532171 H2887818 00884450532171 H2918277 PG6F90MPX H2409348 00884450532317 H2511382 00884450532317 H2722077 00884450532317 H2785803 00884450532317 H2924202 PG6F90SX H2409345 00884450532300 H2460163 00884450532300 H2510840 00884450532300 H2569151 00884450532300 H2655900 00884450532300 H2662287 00884450532300 H2673516 00884450532300 H2684565 00884450532300 H2728386 00884450532300 H2757266 00884450532300 H2785811 00884450532300 H2800581 00884450532300 H2839562 00884450532300 H2849301 00884450532300 H2862762 00884450532300 H2887819 00884450532300 H2897441 H2908186 PG6F90SX018 H2748635 00884450770788 H2757277 00884450770788 PG7F45MP H2412222 00884450532348 H2418699 00884450532348 H2542766 00884450532348 H2655901 00884450532348 H2673525 00884450532348 H2748340 00884450532348 H2777550 00884450532348 H2785814 00884450532348 H2800582 00884450532348 H2839572 00884450532348 H2868447 PG7F45MPX H2412224 00884450532522 H2516384 00884450532522 H2542770 00884450532522 H2785828 00884450532522 H2821625 00884450532522 PG7F45RX H2412226 00884450532539 H2504197 00884450532539 H2516391 00884450532539 H2519744 00884450532539 H2598860 00884450532539 H2728387 00884450532539 H2785833 00884450532539 H2800586 00884450532539 H2868453 00884450532539 PG7F45S H2412217 00884450532324 H2418697 00884450532324 H2460167 00884450532324 H2510841 00884450532324 H2532530 00884450532324 H2542769 00884450532324 H2552520 00884450532324 H2613498 00884450532324 H2626404 00884450532324 H2643178 00884450532324 H2648628 00884450532324 H2655902 00884450532324 H2673527 00884450532324 H2684557 00884450532324 H2684558 00884450532324 H2748341 00884450532324 H2757267 00884450532324 H2785822 00884450532324 H2785825 00884450532324 H2800583 00884450532324 H2821621 00884450532324 H2839576 00884450532324 H2849302 00884450532324 H2857647 00884450532324 H2862767 00884450532324 H2877545 00884450532324 H2887820 00884450532324 PG7F45SX H2412223 00884450532515 H2542777 00884450532515 H2569153 00884450532515 H2613501 00884450532515 H2633747 00884450532515 H2648629 00884450532515 H2662288 00884450532515 H2757268 00884450532515 H2785838 00884450532515 H2813138 00884450532515 H2821630 00884450532515 H2830859 00884450532515 H2862955 00884450532515 H2901997 00884450532515 H2908071 00884450532515 PG7F65SX H2412228 00884450532546 H2532532 00884450532546 H2542780 00884450532546 H2569154 00884450532546 H2655903 00884450532546 H2662289 00884450532546 H2684568 00884450532546 H2728403 00884450532546 H2757269 00884450532546 H2777551 00884450532546 H2785844 00884450532546 H2800623 00884450532546 H2800624 00884450532546 H2830860 00884450532546 H2839583 00884450532546 H2852759 00884450532546 H2862036 00884450532546 H2877546 00884450532546 H2897438 00884450532546 PG7F90SX H2412230 00884450532553 H2504198 00884450532553 H2532533 00884450532553 H2552521 00884450532553 H2569155 00884450532553 H2642734 00884450532553 H2673530 00884450532553 H2684574 00884450532553 H2722063 00884450532553 H2728405 00884450532553 H2748434 00884450532553 H2757270 00884450532553 H2785849 00884450532553 H2800625 00884450532553 H2839584 00884450532553 H2872524 00884450532553 H2887821 00884450532553 PG8F45MPX H2412243 00884450532584 H2504220 00884450532584 H2643177 00884450532584 H2673531 00884450532584 H2763275 00884450532584 H2785853 00884450532584 PG8F45S H2412235 00884450532560 H2510846 00884450532560 H2532542 00884450532560 H2542785 00884450532560 H2613504 00884450532560 H2662291 00884450532560 H2684570 00884450532560 H2704559 00884450532560 H2722036 00884450532560 H2730569 00884450532560 H2748435 00884450532560 H2777552 00884450532560 H2785858 00884450532560 H2800627 00884450532560 H2800628 00884450532560 H2830861 00884450532560 H2839586 00884450532560 H2868462 00884450532560 H2887822 00884450532560 H2897437 H2908223 PG8F45SX H2412236 00884450532577 H2552617 00884450532577 H2673534 00884450532577 H2684576 00884450532577 H2722074 00884450532577 H2728407 00884450532577 H2757271 00884450532577 H2785870 00884450532577 H2800629 00884450532577 H2800630 00884450532577 H2821695 00884450532577 H2839596 00884450532577 H2862038 00884450532577 H2908260 00884450532577 PG8F65SX H2412245 00884450532591 H2460112 00884450532591 H2542788 00884450532591 H2552618 00884450532591 H2684578 00884450532591 H2722075 00884450532591 H2757272 00884450532591 H2763281 00884450532591 H2777554 00884450532591 H2785875 00884450532591 H2800632 00884450532591 H2852765 00884450532591 H2857843 00884450532591 H2902016 H2908269 H2918283 PG8F90SX H2405216 00884450532607 H2460113 00884450532607 H2553764 00884450532607 H2569156 00884450532607 H2613505 00884450532607 H2648630 00884450532607 H2684580 00884450532607 H2757273 00884450532607 H2785881 00884450532607 H2800634 00884450532607 H2830862 00884450532607 H2887823 00884450532607 H2897357 00884450532607 H2902017 X9PG700001 H2602047 00884450732311 H2602053 00884450732311 H2602058 00884450732311 H2661600 00884450732311 H2669110 00884450732311 H2673536 00884450732311 H2673971 00884450732311 H2708403 00884450732311 H2733527 00884450732311 H2733529 00884450732311 H2785885 00884450732311 H2792306 00884450732311 H2800635 00884450732311 H2800638 00884450732311 H2800640 00884450732311 H2801947 00884450732311 H2801950 00884450732311 H2801953 00884450732311 H2801957 00884450732311 H2816122 00884450732311 H2816123 00884450732311 H2816124 00884450732311 H2816125 00884450732311 H2816126 00884450732311 H2816127 00884450732311 H2816128 00884450732311 H2816129 00884450732311 H2816130 00884450732311 H2816132 00884450732311 H2825472 00884450732311 H2825559 00884450732311 H2825561 00884450732311 H2868241 00884450732311 H2868242 00884450732311 H2868472 00884450732311 H2877553 00884450732311 H2877559 00884450732311 H2887825 00884450732311 H2887826 00884450732311 H2893157 00884450732311 H2897363 00884450732311 H2897364 00884450732311 H2897365 00884450732311 H2897371 00884450732311 H2897372 00884450732311 H2897373 00884450732311 H2908284 00884450732311 H2908285 H2908294 H2913623 H2913624 H2913626 H2918302 Note - 23 additional lot Numbers added on 06/14/2024
FEI Number 1721504
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 W Merit Pkwy
South Jordan UT 84095-2416
For Additional Information ContactMerit Customer Service
800-356-3748
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionOn 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 RESPONSE@merit.com. 6. Please fill out, scan and email the completed Customer Response Form to Customer Service at RESPONSE@merit.com within 7 calendar days. If any questions - contact the Merit Sales Representative or Merit Customer Service via email at RESPONSE@merit.com or via phone at 801-208-4381 Hours: 6 am to 6 pm MST/Mon -Fri.
Quantity in Commerce52,410 (updated 06/14/2024)
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DYB
-
-