Cordis Corporation

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

• Filter, Intravascular, CardiovascularDTK2,335
• Catheter, Angioplasty, Peripheral, TransluminalLIT1,602
• Temporary Carotid Catheter For Embolic CaptureNTE1,044
• Device, Hemostasis, VascularMGB1,036
• Stents, Drains And Dilators For The Biliary DuctsFGE901
• Wire, Guide, CatheterDQX744
• Catheter, Intravascular, DiagnosticDQO660
• Stent, CoronaryMAF404
• Introducer, CatheterDYB277
• Catheter, PercutaneousDQY268

Recent recalls

• 2021-09-15TerminatedDevice Design

  Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB

  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.

• 2021-09-15TerminatedDevice Design

  Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB

  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.

• 2021-09-15TerminatedDevice Design

  Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A

  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.

• 2021-09-15TerminatedDevice Design

  Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B

  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.

• 2021-09-15TerminatedDevice Design

  Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C

  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.

• 2020-02-28TerminatedPending

  Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S

  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.

• 2016-03-15TerminatedMixed-up of materials/components

  CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneous entry of an intravascular device. A vessel dilator facilitates the percutaneous entry of the CSI by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel.

  Incorrect cannula of the sheath introducer (smaller than intended).

• 2015-08-18TerminatedLabeling Change Control

  RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patients (>18 years) with drug resistant hypertension to denervate the renal arteries to reduce blood pressure.

  Potential Damage may occur to the helical tip of the RENLANE Renal Denervation Catheter, if the hemostasis valve of the arterial access device is not fully open before insertion or withdrawal of the catheter.

• 2015-01-16TerminatedLabeling design

  Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for post- dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.

  One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was not sterilized.

• 2014-08-28TerminatedEnvironmental control

  Cordis EMPIRA NC RX PTCA Dilatation Catheter

  The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover. This may lead to balloon burst, shaft separation or deflation difficulties, which could result in procedural delay, vessel trauma or surgery.