Angiodynamics, Inc. recalls AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
Potential for procedural delays or interruptions during use of the Auryon Atherectomy System due to the Auryon Atherectomy System not advancing to the Activation (Ready) mode.
Read the official notice →- Date
- 2025-01-08
- Country
- United States
- Brand
- Angiodynamics
- Product
- AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
- Classification
- Class II
- Units
- US Nationwide distribution to the states of AR, AZ, CA, CO, CT, FL, GA, IL,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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USAngiodynamics, Inc. recalls Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145…
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
FDA · DeviceAngiodynamics, Inc.Worldwide distribution - US Nationwide and the countries of Austria,…Official notice →- 2025-03-26
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Angiodynamics, Inc. recalls IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
Product is mislabeled with the incorrect fill volume.
FDA · DeviceAngiodynamics, Inc.US Nationwide distribution in the states of AZ, DC, FL, TN, TX, VA, WI.Official notice → - 2024-08-07
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Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length)
- 2024-07-10
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Angiodynamics, Inc. recalls IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
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Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
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