Cordis recalls

8 official recalls and safety alerts involving Cordis since 2021-11, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Cordis or the relevant agency.

  1. 2025-04-09
  2. US
    Drugs & medicalClass II

    Cordis US Corp recalls Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only

    product mix-up; Vascular stent labeled as one size but contains a different size.

    FDA · DeviceCordis US CorpUS Distribution to states of: AR, AZ, FL, NJ, TN; and OUS Foreign country of:…Official notice →
  3. 2025-03-19
  4. US
  5. 2024-01-17
  6. US
    Drugs & medicalClass II

    Cordis US Corp recalls MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.

    Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as labeled as lot F2322903…

    FDA · DeviceCordis US CorpUS: NC, WV, TN, MS, MI, OH, CAOfficial notice →
  7. 2023-11-15
  8. US
    Drugs & medicalClass I

    Cordis US Corp recalls Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter

    Non-sterile product labeled as sterile was distributed.

    FDA · DeviceCordis US CorpUS Distribution to: OKOfficial notice →
  9. 2023-05-17
  10. US
    Drugs & medicalClass I

    Cordis US Corp recalls ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC

    There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical…

    FDA · DeviceCordis US CorpWorldwide distribution.Official notice →
  11. 2022-12-21
  12. US
    Drugs & medicalClass II

    Cordis US Corp recalls Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient.

    There is a potential for separation at the male connector.

    FDA · DeviceCordis US CorpNationwide distribution to AZ, CA, DC, FL, GA, KY, LA, MD, MS, NY, OH, TX, WV,…Official notice →
  13. 2022-07-20
  14. US
    Drugs & medicalClass II

    Cordis US Corp recalls PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.

    Potential for stent dislodgement and associated failures related to two specific sizes of the device.

    FDA · DeviceCordis US CorpUS Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE,…Official notice →
  15. 2021-11-24
  16. US
    Drugs & medicalClass II

    Cordis Corporation recalls SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in…

    There is a potential for distal tip dislodgement or separation.

    FDA · DeviceCordis CorporationUS Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution…Official notice →