Miami Lakes, FL, United States
Cordis US Corp recalls
17 recalls recorded since 2018, most recently on 4 March 2025. 8 are listed as ongoing. Status and classification are as published by the FDA.
Recalls17
Ongoing (FDA)8
Terminated or completed9
Class I (FDA)4
Ongoing Class II Medical devices
- Recall started
- 4 March 2025
- Reason
- product mix-up; Vascular stent labeled as one size but contains a different size.
- Distribution
- US Distribution to states of: AR, AZ, FL, NJ, TN; and OUS Foreign country of: Japan
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1510-2025, Z-1511-2025
- Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
- Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx Only
Ongoing Class II Medical devices
- Recall started
- 7 February 2025
- Reason
- Catheter manufactured at the incorrect length.
- Distribution
- US: WA OUS: Japan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1330-2025
- 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 vascula
Ongoing Class II Medical devices
- Recall started
- 28 November 2023
- Reason
- 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.
- Distribution
- US: NC, WV, TN, MS, MI, OH, CA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0674-2024, Z-0675-2024
- MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.
- MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites
Ongoing Class I Medical devices
- Recall started
- 26 September 2023
- Reason
- Non-sterile product labeled as sterile was distributed.
- Distribution
- US Distribution to: OK
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0286-2024
- Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
Ongoing Class I Medical devices
- Recall started
- 24 March 2023
- Reason
- 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.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1489-2023, Z-1490-2023, Z-1487-2023, Z-1494-2023, Z-1495-2023, Z-1484-2023, Z-1488-2023, Z-1492-2023, Z-1485-2023, Z-1483-2023, Z-1493-2023, Z-1496-2023 and 2 more
- ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC
- ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM
- ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC
- ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM
- ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM
- ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC
- ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MC
- ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE
- and 6 more product lines
Ongoing Class II Medical devices
- Recall started
- 7 November 2022
- Reason
- There is a potential for separation at the male connector.
- Distribution
- Nationwide distribution to AZ, CA, DC, FL, GA, KY, LA, MD, MS, NY, OH, TX, WV, WY and PR. International distribution to Japan, Korea, Republic of, United Arab Emirates, Austria, Belgium, Czech Republic, Germany, Spain, France, United Kingdom, Iceland, Ireland, Israel, Netherlands, Portugal, Russia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0720-2023
- Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient.
Ongoing Class II Medical devices
- Recall started
- 20 May 2022
- Reason
- Potential for stent dislodgement and associated failures related to two specific sizes of the device.
- Distribution
- US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, and WY. There was also government/military distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1363-2022
- PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.
Ongoing Class II Medical devices
- Recall started
- 1 October 2021
- Reason
- There is a potential for distal tip dislodgement or separation.
- Distribution
- US Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0218-2022, Z-0220-2022, Z-0221-2022, Z-0219-2022, Z-0216-2022, Z-0217-2022
- 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 the biliary tree.
- SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
- SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
- SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
- SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
- SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Terminated Class I Medical devices
- Recall started
- 21 July 2021
- Terminated
- 9 September 2024
- Reason
- Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular devices and the vessel wall, which can lead to marker band movement or dislodgement.
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Canada, Europe.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2428-2021, Z-2432-2021, Z-2431-2021, Z-2429-2021, Z-2430-2021
- Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB
- Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C
- Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B
- Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB
- Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A
Terminated Class II Medical devices
- Recall started
- 19 July 2021
- Terminated
- 16 February 2023
- Reason
- The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to the balloon.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CA, OH, and the countries of Switzerland, Portugal, and Poland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2235-2021
- Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
Terminated Class II Medical devices
- Recall started
- 9 June 2021
- Terminated
- 16 February 2023
- Reason
- The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AR, AZ, FL, GA, IN, NC, NJ, and WV. The country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2079-2021
- Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
Completed Class I Medical devices
- Recall started
- 11 February 2021
- Reason
- Distal tip may become separated from the lumen wire in specific lots.
- Distribution
- US (except MT and NM) and Taiwan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1257-2021
- PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC, PC0740RXC, PC0820RXC, PC0830RXC, PC0840RXC, PC0920RXC, PC0930RXC, PC094
Terminated Class II Medical devices
- Recall started
- 8 January 2020
- Terminated
- 13 January 2023
- Reason
- Cordis is recalling one (1) lot of POWERFLEX P3 PTA Dilatation Catheter due to the potential for body/shaft voids in the proximal seal area.
- Distribution
- US and UK
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1477-2020
- Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S
Terminated Class II Medical devices
- Recall started
- 4 October 2019
- Terminated
- 14 December 2020
- Reason
- Product was manufactured utilizing an expired inner body.
- Distribution
- US distribution to AL, AZ, FL, MN, and MO
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0250-2020
- Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.
Terminated Class III Medical devices
- Recall started
- 7 February 2019
- Terminated
- 3 November 2021
- Reason
- Frayed pieces of the mounting card being inside the primary packaging.
- Distribution
- Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico and Guam Singapore and Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1198-2019
- Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular
Terminated Class II Medical devices
- Recall started
- 5 September 2018
- Terminated
- 11 February 2021
- Reason
- Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test).
- Distribution
- Worldwide distribution - US Nationwide in the states of AL, CA, FL, GA, IL, IN, KS, KY, LA, MA, MD, MO, MS, NC, ND, NJ, OH, PA, SC, TN, TX, and WI. Countries of Japan and Netherlands.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0390-2019
- Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of
Terminated Class II Medical devices
- Recall started
- 15 November 2017
- Terminated
- 4 November 2019
- Reason
- Potential for cracked luer hubs
- Distribution
- Worldwide Distribution - US Nationwide in the states of MI, AL, AR, CA, CO, FL, GA, IL, IA, LA, MS, NJ, NC, OH, OK, OR, PA, TN, TX, VA, WV, WI, MI, NY, MA, NV, RI, IN, WA, AZ, DC, Puerto Rico and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0324-2018
- Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the palliation of malignant strictures in the biliary tree.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.