Angiographic Catheter Recall: Cordis SUPER TORQUE Entrapment and Dislodgement Risk
Cordis is recalling its SUPER TORQUE MB Angiographic Catheter worldwide because it may become entrapped between endovascular devices and the vessel wall. This entrapment can cause marker band movement or dislodgement.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is classified as FDA Class I, which establishes a minimum severity score of 4 per the rubric. Although no injuries or deaths have been reported, Class I recalls represent serious potential hazards to patient safety.
Plain-English summary
Cordis Corporation is recalling the SUPER TORQUE MB Angiographic Catheter (with marker bands) worldwide, including distribution in the United States, Canada, and Europe. A total of 45 units are affected.
The catheter may become entrapped between endovascular devices and the vessel wall during endovascular procedures. This entrapment can lead to movement or dislodgement of the marker bands.
Healthcare facilities using this product should review their inventory for affected units and contact Cordis Corporation for guidance on proper use, handling, and any necessary steps for affected devices.
The recalled product
- Product
- Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB
- Manufacturer
- Cordis Corporation
- Hazard
- Affected units
- 45
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All codes
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Cordis Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Cordis Corporation
See all →- HighSMART FLEX Biliary Stent System Recalled Due to Potential Tip Dislodgement
FDA (Devices) · 2021-11-24
- HighSMART FLEX 6x120 Biliary Stent System Recalled for Potential Distal Tip Dislodgement
FDA (Devices) · 2021-11-24
- HighSMART FLEX Biliary Stent System Recalled for Potential Distal Tip Dislodgement
FDA (Devices) · 2021-11-24
- HighCordis SMART FLEX Biliary Stent System Recalled for Distal Tip Separation
FDA (Devices) · 2021-11-24
- HighFDA Recalls SMART FLEX Biliary Stents Due to Distal Tip Separation Risk
FDA (Devices) · 2021-11-24
Same hazard · entrapment
See all →- Severe
- High
- Severe
- Severe
- Severe
Similar recalls
- HighCanon Medical Recalls Catheterization Tables Due to Potential Tilt Hazard
FDA (Devices) · 2021-03-24
- HighCanon Catheterization Table Recall Due to Potential Tilt Hazard
FDA (Devices) · 2021-03-24
- ModerateCordis ADROIT 6F Guiding Catheter Recalled for Labeling Error
FDA (Devices) · 2013-10-09
- SevereANGIOGUARD Emboli Capture Guidewire System recalled due to potential device separation
FDA (Devices) · 2023-05-17
- HighCook Inc. Recalls Torcon NB Advantage Catheters Due to Sterility Concerns
FDA (Devices) · 2019-11-27
- SevereBoston Scientific Cardiac Catheters Recalled for Inner Lining Delamination
FDA (Devices) · 2024-05-22