Angiodynamics, Inc. is recalling 1,114 units of Soft-Vu Kumpe catheters used for diagnostic imaging due to a labeling error. While the outer box correctly identifies the product, the inner sterile pouch may be labeled with the wrong catheter length, potentially leading a doctor to use the incorrect tool during a procedure. This recall affects the Soft-Vu Kumpe 5F x 40cm and 5F x 65cm models distributed nationwide between June and July 2024. If you have these medical devices, contact your healthcare provider or Angiodynamics immediately for instructions on returning the affected stock.
A physician may select and attempt to use a catheter of the wrong length because the inner pouch label does not match the actual device or the outer box. This mismatch can cause delays in critical diagnostic procedures or potential injury if the incorrect length is used during a vascular intervention.
Manufacturer notification and return of product
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.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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