Cordis Angiographic Catheter Extensions Recalled for Male Connector Separation Risk
Cordis angiographic catheter extensions may experience separation at the male connector during use. Approximately 2,915 US units were distributed; users should verify affected lot numbers.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard (connector separation) is potential and theoretical with no documented patient harm to date. Meets rubric criterion for risk-of-harm medical devices where injury has not yet been reported.
Plain-English summary
Cordis US Corp is recalling Angiographic Catheter Extensions used to deliver fluid from power injectors to catheters during angiographic procedures. The recalled devices have been distributed nationwide to facilities in Arizona, California, Washington DC, Florida, Georgia, Kentucky, Louisiana, Maryland, Mississippi, New York, Ohio, Texas, West Virginia, and Wyoming, as well as to Puerto Rico. International distribution occurred in Japan, Korea, United Arab Emirates, Austria, Belgium, Czech Republic, Germany, Spain, France, United Kingdom, Iceland, Ireland, Israel, Netherlands, Portugal, and Russia.
The potential hazard is separation at the male connector, which could affect proper fluid delivery during medical procedures. A total of 16,950 units were affected, including 2,915 distributed in the US and 14,000 overseas. Affected products carry catalog numbers 502-100D, 502-101D, or 502-102D with specific lot numbers detailed in FDA documentation.
Healthcare facilities should verify whether they have affected lots in their inventory by checking the lot numbers provided in the FDA recall notice. Facilities with affected units should contact Cordis US Corp for guidance on return or replacement of affected devices.
The recalled product
- Product
- Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient.
- Manufacturer
- Cordis US Corp
- Hazard
- connector-separation
- equipment-failure
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 (20)
- UDI-DI: (01)2070532064702
- Catalog Number (Lot Number): 502-100D (18068258
- 18069744
- 18101041
- 18111609)
- 502-101D (18062881
- 18081307
- 18064731
- 18086388
- 18066535
- 18097369
- 18070824
- 18102623
- 18077497)
- 502-102D (18060997
- 18078225
- 18099118
- 18062882
- 18079156
- 18104313
Distribution
Distributed nationwide across the United States.
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