Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015) recallZ-0742-2018 · Angiodynamics, Inc. · initiated Sep 22, 2017
Class II Terminated All recalls posted in February 2018
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Angiodynamics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product was placed into distribution prior to completion of all required post sterilization release activities.
FDA root cause category: Process control
What the company is doing
Consignees were contacted by phone and by a letter sent via Federal Express. Consignees were instructed to stop using product, segregate affected product, and return the product to the firm along with a reply verification tracking form. For further questions, please call (518) 795-1676.
Recall details
- Recall number
- Z-0742-2018
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Sep 22, 2017
- Posted by the FDA
- Feb 13, 2018
- Recalling firm
- Angiodynamics, Inc.
- Quantity
- 28
- Product code
- DQO
- FDA submissions
- K112452
- Distribution
- US Distribution to the states of : AL, CA, CT, FL, GA, IL, IN, MD, MI, MN, MO, OH, OR, TX.
Product description
Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201 AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.
Code information (models, lots, serial numbers)
Lot Number: 5229642; Manufactured 6-Sep-17; Expiration Date: 31-Aug-20
Other devices under the same FDA submission
66 devices cleared under K112452 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Soft-Vu 10732301Angiodynamics, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall6 reports
- Soft-Vu 10732701Angiodynamics, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall2 reports
- AccuVu 13709804Angiodynamics, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall2 reports
- Soft-Vu 10714009Angiodynamics, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall1 report
- Soft-Vu 10734301Angiodynamics, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall1 report
- Soft-Vu 10707103Angiodynamics, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Soft-Vu 10714001Angiodynamics, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Soft-Vu 10714002Angiodynamics, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Soft-Vu 10714011Angiodynamics, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Soft-Vu 10714014Angiodynamics, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Soft-Vu 10714016Angiodynamics, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
- Soft-Vu 10714017Angiodynamics, Inc. · CATHETER, INTRAVASCULAR, DIAGNOSTIC1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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