Olympus Corporation of the Americas is recalling 60 units of the EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit. The kits were found to contain an incorrectly sized 4mm x 4cm urinary tract balloon catheter instead of the required 8mm x 15cm nephrostomy tract balloon catheter. Use of the wrong size catheter could lead to procedural complications during nephrostomy tract dilation.
The smaller, incorrectly included balloon may not properly dilate the nephrostomy tract as intended during medical procedures. This size discrepancy could lead to procedural delays, treatment failure, or the need for additional medical interventions to achieve the desired clinical outcome.
Device kits incorrectly contained a 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815).
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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