Siemens ACUSON AcuNav Volume Intracardiac Echocardiography Catheter Recalled for Perforation Risk
Siemens Medical Solutions USA is recalling ACUSON AcuNav Volume Intracardiac Echocardiography Catheters due to reports of left atrial perforations and Atrioventricular Node block.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 recall is classified as FDA Class II and involves reported adverse events including left atrial perforations and Atrioventricular Node block, which constitute significant injury reports consistent with the 'Severe' rubric criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F (Model Number: 10855958). The recall is being conducted due to adverse events reported to the firm involving left atrial perforations and Atrioventricular Node block.
The affected devices were distributed in the United States to the states of Arizona, California, Florida, Georgia, Illinois, Kentucky, Massachusetts, Michigan, Minnesota, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, Virginia, Washington, and West Virginia. The devices were also distributed in Canada. The recall includes specific serial numbers listed in the agency's structured data.
Healthcare providers and consumers should stop using the affected devices and contact Siemens Medical Solutions USA, Inc. for further instructions or a replacement. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F
- Manufacturer
- Siemens Medical Solutions USA, Inc.
Distribution
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