Home / Recalls / Cordis Corporation / Z-2428-2021

Z-2428-2021 Class I Terminated

Recalled by Cordis Corporation — Miami Lakes, FL

Recall Details

Product Type
Devices
Report Date
September 22, 2021
Initiation Date
July 21, 2021
Termination Date
September 9, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
45 units

Product Description

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

Reason for Recall

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 Pattern

Worldwide distribution - US Nationwide distribution and the countries of Canada, Europe.

Code Information

All codes

Other recalls by Cordis Corporation

  • Z-0217-2022 Class II — SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indica (October 1, 2021)
  • Z-0219-2022 Class II — SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicate (October 1, 2021)
  • Z-0221-2022 Class II — SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indic (October 1, 2021)
  • Z-0216-2022 Class II — SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicate (October 1, 2021)
  • Z-0220-2022 Class II — SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indica (October 1, 2021)
  • Z-0218-2022 Class II — SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indica (October 1, 2021)
  • Z-2432-2021 Class I — Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C (July 21, 2021)
  • Z-2430-2021 Class I — Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598A (July 21, 2021)
  • Z-2431-2021 Class I — Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598B (July 21, 2021)
  • Z-2429-2021 Class I — Cordis 5F SUPER TORQUE PIG PIGTAIL SPECIAL, Angiographic Catheter, REF SRD7040MB (July 21, 2021)