Stryker Recalls Angiographic Catheters Due to Tip Breakage
Stryker is recalling 167 AngioDynamics Soft Vu Omni Flush Angiographic Catheters because the tips broke off before use.
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: The agency classified this as an FDA Class I recall, which mandates a minimum severity score of 4 per the rubric.
Plain-English summary
Stryker Sustainability Solutions is recalling 167 units of the AngioDynamics Soft Vu Omni Flush Angiographic Catheter, Model Number 10732203. The recall was initiated because the tips of two catheters broke off prior to being used on patients.
The affected products were distributed worldwide, including in the United States and Canada. In the US, the products were distributed to the states of Texas, Utah, Pennsylvania, California, Vermont, Massachusetts, Washington, Virginia, New York, Maryland, and Connecticut.
Healthcare facilities should stop using the affected catheters and contact Stryker Sustainability Solutions for instructions on how to return the products.
The recalled product
- Product
- AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203
- Manufacturer
- Stryker Sustainability Solutions
- Hazard
- Affected units
- 167
Distribution
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