← Every firm
Cordis US Corp FDA Recalls
22 recalls on file across devices, 15 of them Class I and 22 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx OnlyClass IIMar 4, 2025product mix-up; Vascular stent labeled as one size but cont |
| Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx OnlyClass IIMar 4, 2025product mix-up; Vascular stent labeled as one size but cont |
| Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intClass IIFeb 7, 2025Catheter manufactured at the incorrect length. |
| MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sitesClass IINov 28, 2023Cordis became aware that the label for the carton box contai |
| MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.Class IINov 28, 2023Cordis became aware that the label for the carton box contai |
| Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheterClass ISep 26, 2023Non-sterile product labeled as sterile was distributed. |
| ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMClass IMar 24, 2023There is a potential for separation of the ANGIOGUARD RX / |
| ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814REClass IMar 24, 2023There is a potential for separation of the ANGIOGUARD RX / |
| ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMCClass IMar 24, 2023There is a potential for separation of the ANGIOGUARD RX / |
| ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMCClass IMar 24, 2023There is a potential for separation of the ANGIOGUARD RX / |
| ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMClass IMar 24, 2023There is a potential for separation of the ANGIOGUARD RX / |
| ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMCClass IMar 24, 2023There is a potential for separation of the ANGIOGUARD RX / |
| ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMCClass IMar 24, 2023There is a potential for separation of the ANGIOGUARD RX / |
| ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814REClass IMar 24, 2023There is a potential for separation of the ANGIOGUARD RX / |
| ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814REClass IMar 24, 2023There is a potential for separation of the ANGIOGUARD RX / |
| ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REClass IMar 24, 2023There is a potential for separation of the ANGIOGUARD RX / |
| ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMClass IMar 24, 2023There is a potential for separation of the ANGIOGUARD RX / |
| ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MCClass IMar 24, 2023There is a potential for separation of the ANGIOGUARD RX / |
| ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RECClass IMar 24, 2023There is a potential for separation of the ANGIOGUARD RX / |
| ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMCClass IMar 24, 2023There is a potential for separation of the ANGIOGUARD RX / |
| Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injectClass IINov 7, 2022There is a potential for separation at the male connector. |
| PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG399Class IIMay 20, 2022Potential for stent dislodgement and associated failures rel |