C.R. Bard recalled 116 units of its InLay Optima Ureteral Stent Kit on November 6, 2025. A labeling discrepancy may cause the actual size of the stent to differ from what is indicated on the label. The recall affects distribution across the U.S. and several countries worldwide.
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact C.R. Bard Inc or your healthcare provider for instructions. Notification method: Letter
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The Bard InLay Optima Ureteral Stent Kit is a medical device used to support the ureters and assist in urine flow. It is commonly used in patients undergoing urinary tract procedures.
The labeling discrepancy means that the size indicated on the packaging may not correspond to the actual size of the stent. This could lead to improper implantation and complications during medical procedures.
This recall is not part of a broader industry pattern.
Patients using this stent may face risks if the actual device size does not match the label, potentially leading to complications or ineffective treatment.
Product information, including the model number, can typically be found on the box or packaging of the ureteral stent kit.
Expect a timeline of 4-6 weeks for any processing of refunds or replacements.
Document all communications with C.R. Bard Inc. regarding the recall, including the date and details of your contact.
The recalled product is Bard InLay Optima Ureteral Stent Kit, Size: 6 Fr. x 14 cm, REF 787614. The kits were distributed worldwide, including across 17 U.S. states and several countries such as Canada and the United Kingdom.
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