Cordis US Corp
FDA adverse event reports naming Cordis US Corp as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: CORDIS US CORP.
- Total reports
- 2,069
- Deaths
- 2
- Injuries
- 340
- Malfunctions
- 1,727
Reports per year
Source: FDA adverse event reports by year received, 2023–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Device, Hemostasis, VascularMGB1,560
- Catheter, Intravascular, DiagnosticDQO186
- Catheter, Angioplasty, Peripheral, TransluminalLIT105
- Catheter, PercutaneousDQY41
- Stents, Drains And Dilators For The Biliary DuctsFGE31
- Dilator, Vessel, For Percutaneous CatheterizationDRE29
- Stent, CarotidNIM27
- Temporary Carotid Catheter For Embolic CaptureNTE24
- Filter, Intravascular, CardiovascularDTK23
- Introducer, CatheterDYB20
Recent recalls
- 2025-04-03Open, ClassifiedEmployee error
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.
- 2025-04-03Open, ClassifiedEmployee error
Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx Only
product mix-up; Vascular stent labeled as one size but contains a different size.
- 2025-03-13Open, ClassifiedEmployee error
Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
Catheter manufactured at the incorrect length.
- 2024-01-05Open, ClassifiedLabeling Change Control
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 (MX6721, MynxGrip 6/7F) and product from lot F2322903 (MX6721, MynxGrip 6/7F) was labeled as F2322902 (Item MX5021, MynxGrip 5F). The primary label on individual devices is correct.
- 2024-01-05Open, ClassifiedLabeling Change Control
MYNXGRIP 6F/7F, REF MX6721, 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 (MX6721, MynxGrip 6/7F) and product from lot F2322903 (MX6721, MynxGrip 6/7F) was labeled as F2322902 (Item MX5021, MynxGrip 5F). The primary label on individual devices is correct.
- 2023-11-09Open, ClassifiedProcess control
Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
Non-sterile product labeled as sterile was distributed.
- 2023-05-11Open, ClassifiedVendor change control
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC
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 intervention, or stroke; while a replacement device is prepared.
- 2023-05-11Open, ClassifiedVendor change control
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC
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 intervention, or stroke; while a replacement device is prepared.
- 2023-05-11Open, ClassifiedVendor change control
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC
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 intervention, or stroke; while a replacement device is prepared.
- 2023-05-11Open, ClassifiedVendor change control
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC
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 intervention, or stroke; while a replacement device is prepared.
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