Drug & Device Safety Atlas

FDA recall record · openFDA

Cordis US Corp

20 FDA recalls on record (2023–2025) — 20 device. 20 still ongoing.

15
Class I (most serious)
5
Class II
0
Class III
20
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are 14
product mix-up; Vascular stent labeled as one size but contains a different size. 2
Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of Myn 2
Catheter manufactured at the incorrect length. 1
Non-sterile product labeled as sterile was distributed. 1

Recalls

ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC Class I 2023-03-24 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM Class I 2023-03-24 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC Class I 2023-03-24 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM Class I 2023-03-24 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM Class I 2023-03-24 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC Class I 2023-03-24 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MC Class I 2023-03-24 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE Class I 2023-03-24 Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter Class I 2023-09-26 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC Class I 2023-03-24 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC Class I 2023-03-24 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RE Class I 2023-03-24 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE Class I 2023-03-24 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RE Class I 2023-03-24 ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC Class I 2023-03-24 Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only Class II 2025-03-04 Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for int Class II 2025-02-07 Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx Only Class II 2025-03-04 MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites. Class II 2023-11-28 MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites Class II 2023-11-28

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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