Class 1 Device Recall Centimeter Sizing Catheter

• Date Initiated by Firm: April 02, 2026
• Date Posted: May 01, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1934-2026
• Recall Event ID: 98682
• Product Classification: Catheter, intravascular, diagnostic - Product Code DQO
• Product: Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials and designs (e.g., polyethylene or nylon, non-braided or braided with 1:1 torque). The choice of catheter material for different angiographic procedures should be based on the physician s experience.
• Code Information: UDI-DI 00827002119161 Lots 16905390 16905390X 16888263 NS16888264 16905391 16905391X 16909577 16918137 16924645 16924646 16928311 16928311X 16928312 16928313 16947353 16899656 16899655 16894976 16879299 16890985 16903201 16885859 16890986 16890982 16888268 16904428 16899658 16903202 16903203 16903204 16905389 16888267 16890983 16888269 16890981 16879296 16864346 16879301 16888261 16864344 16864351 16846774 16869144 16879300 16864350 16869143 16869143X NS16861721 16879297 16861735 16864347 16864347X 16882666 16899657 16890984 16899659 16888266 16861729 16857145 16858460 16857141 16861730 16861724 16858463 16852206 16855698 16858458 16858461 16858462 16858462X 16861726 16861727 16861728 16852209 16855686 16855696 16857146 16859718 16861720 16861723 16861725 16857137 16857142 16857139 16857140 16877835 16864345 16882665 16864353 16864348 16865462 16865462X 16879302 16843256 16833320 16843258 16845235 16845236 16839886 16845242 16845244 16845223 16845223X 16845226 16846777 16845230 16845227 16833315 16845218 16845246 16845233 16846778 16845229 16845240 16846779 16845241 16855694 16851384 16855695 16852208 16855693 16855697 16852207 16851381 16861733 16852711 16855688 16849691 NS16845220 NS16845220X 16846771 16846776 16845231 16851379 16851378 16851374 16846775 16851376 16855690 16849688 16846770 16846773 16861731 16861731X 16861732 16864352 16864354 NS16861722 16857144 16855691 16855692 16846772 16851380 16861734 16861734X 16864349 16851382 16857143 16857143X 16833228 16833298 16833292 16833321 16845239 16836838 16839887 16823055 16807168 16816808 16823045 16833290 16833299 16836839 16836839X 16833316 16833314 16833310 16823062 16823062X 16825484 16833229 16833230 16833231 16833232 16833289 16833307 16833308 16833309 16833311 16833312 16833313 16833296 16845237 16802095 16833301 16833302 16843254 16843255 16843257 16845234 16833297 16833293 16833304 16833300 16802091 16802091X 16833291 16833303 16800397 16800399 16802092 16823046 16823047 16823048 16823049 16823050 16823051 16823052 16823053 16823054 16823059 16823060 16823061 16825481 16830073 16823064 16825482 16823056 16825483 16802093 16833306 16802094 16800398 16833305 16823063 16833226 16833227 16841922 16845228 16845238 16849686 16849687 NS16845221 16833319 16833318 16849689 16849690 16849692 16849693 16851375 16851377 16833317 16845224 16845222 16845243 16845245 16845225 16845219 16845232 16855689 16851383 16851385 16855687 16823058 16823057 16830072 16833295 16833294 16785145 16800393 16785154 16800392 16785156 16763331 16763325 NS16760664 16779065 16763326 16785147 16781909 16785146 16785148 16785149 16785150 16785155 16800395 16800395X 16800396 16800396X 16795825 16778880 16778880X 16778879 16778886 16778882 16768075 16778874 16778875 16778876 16778877 16778878 16779066 16779067 16779073 16780712 16780713 16755901 16763332 16760667 16768078 16763329 16763330 16713193 16726029 16727639 16726031 16720477 16721538 16731107 16731108 16731109 16731110 16734930 16734931 NS16731105 NS16731106 16726034 16721055 16752735 16718409 16734933 16716743 16752732 16748454 16748455 16734939 16720476 16779063 16778884 16779064 16778885 16779068 16716747 16716742 16716745 16781899 16783621 16785142 16778873 NS16760663 16742510 16742505 16781901 16781900 16781906 16781902 16763334 16763327 16742512 16742511 16742511X 16758715 16755900 16760665 16758716 16758713 16778881 16758712 16758717 16755905 16758718 16763328 16800390 16789989 16789989X 16789992 16789992X 16789991 16789993 16795822 16795823 16797411 16768077 16768076 16779062 16768074 16778883 16779069 16779072 16780717 16779071 16780714 16781908 16781907 16783615 16780719 16780718 16781903 16797412 16800394 16781904 16785153 16789990 16783619 16780715 16780716 16779070 16785143 16785151 16800391 16823044 16823044X 16795826 16813575 16807167 16781905 16785152 16785144 16783620 16783622 16797413 16795824 16807169 16807166 16699267 16700950 16707903 16711577 16711578 16694273 16694279 16696442 16703558 16703557 16713192 16700951 16694277 16694275 16696441 16726030 16726033 16716744 16721060 16718408 16758710 16734936 16721057 16734937 16713194 16721056 16734934 16734938 16752736 16758708 16758711 16716749 16721058 16734935 16734932 16758709 16755904 16716750 16721053 16716748 16726032 16700948 16700948X 16700946 16716741 16758714 16758714X 16716746 16755903 16760666 16755902 16752734 16721059 16783616 16783623 16783618 16783617 16720473 16711579 16711580 16711581 16720472 16720474 16720475 16721061 16721062 16721054 16707899 16700949 16700947 16699182 16694280 16707901 16700945 16699177 16699179
• FEI Number: 1820334
• Recalling Firm/ Manufacturer: Cook Incorporated; 750 N Daniels Way; Bloomington IN 47404-9120
• For Additional Information Contact: Cook Medical Customers Relations Department; 812-339-0235
• Manufacturer Reason for Recall: Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
• FDA Determined Cause: Under Investigation by firm
• Action: On April 2, 2026, the firm began notifying affected consignees via letters titled "URGENT: MEDICAL DEVICE RECALL." Customers were instructed to quarantine affected products in inventory and to immediately cease further distribution and use of the affected products. They should return the affected products to Cook Medical with a copy of the completed Acknowledgement and Receipt form to receive a product credit.
• Quantity in Commerce: 11,253
• Distribution: US distribution nationwide. OUS distribution to Brunei, Brazil, Canda, China, Colombia, Costa Rica, Hong Kong, Israel, India, Japan, South Korea, Macau, New Zealand, Singapore, El Salvador, Taiwan, Uruguay
• Total Product Life Cycle: TPLC 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.