Cordis SUPER TORQUE MB Angiographic Catheter Recalled for Device Entrapment Risk
Cordis Corporation recalls SUPER TORQUE MB angiographic catheters worldwide due to risk of entrapment between endovascular devices and vessel wall, potentially causing marker band 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: FDA Class I recall. The hazard involves risk of catheter entrapment and marker band dislodgement, which could compromise device safety and lead to adverse patient outcomes. However, no deaths, serious injuries, or hospitalizations are reported in the source document.
Plain-English summary
Cordis Corporation has recalled the SUPER TORQUE MB angiographic catheter (REF 532-598C) with marker bands. The recall affects approximately 26,025 units distributed worldwide, including the United States, Canada, and Europe.
The hazard involves potential entrapment of the catheter between endovascular devices and the vessel wall. When entrapment occurs, the marker bands may move or become dislodged, which could compromise the clinical effectiveness and safety of the device during angiographic procedures.
This is a Class I recall, the FDA's most serious classification. Physicians and healthcare facilities using this catheter should implement alternative approaches for affected procedures and contact Cordis Corporation for information about recalled units and potential replacements.
The recalled product
- Product
- Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C
- Manufacturer
- Cordis Corporation
- Affected units
- 26,025
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
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