Rezum System Recall Due to Potential Needle Bond Failure During Prostate Treatment
NxThera is recalling 113 Rezum System units because the needle bond may fail during deployment, posing a risk of injury to patients.
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: The recall is classified as FDA Class II, and the hazard involves a mechanical failure of a medical device during a procedure, which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
NxThera Inc. is recalling 113 units of the Rezum System, Vapor BPH Ablation System, Model Number D2201-003. The recall is due to a defect where the needle bond may not withstand the tension force applied when the shaped needle is deployed into and retracted from prostate tissue to deliver treatments.
The affected units were distributed to healthcare facilities in the United States, specifically in the states of Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Utah, and Washington. The recall includes specific lot numbers and expiration dates as detailed in the agency's structured product information.
Healthcare providers should stop using the affected Rezum System units immediately. Patients who have already received treatment with the recalled devices should contact their healthcare provider for further evaluation and guidance.
The recalled product
- Product
- Rezum System, Vapor BPH Ablation System, Model Number D2201-003. NxThera Inc. 7351 Kirkwood Lane Suite 138 Maple Grove, MN 55369 USA. Intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia (BPH). It is indicated for
- Manufacturer
- NXTHERA
- Hazard
- Affected units
- 113
Distribution
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