AngioDynamics Class II Catheter Recall - Guidewire Passage Defect

Class 2 Device Recall Angiodynamics SoftVu

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| | Class 2 Device Recall Angiodynamics SoftVu | |

SOFT-VU KMP 4F X 65CM 038 NB 0SH;
Catalog No.: 10714014;
Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch);
Box Quantity: 5 pouches; |
| Code Information | SOFT-VU KMP 4F X 65CM 038 NB 0SH;
Catalog No.: 10714014;
Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch);
UDI-DI: 25051684007891(Box), 15051684007894(Pouch);
Lot No.: A2825033, A2825034, A2825132, A2825133, A3725048, A3725049; |
| FEI Number | 1319211 |
| Recalling Firm/
Manufacturer | Angiodynamics, Inc.
603 Queensbury Ave
Queensbury NY 12804-7619 |
| For Additional Information Contact | Kasey Newcomb
978-333-1108 |
| Manufacturer Reason
for Recall | 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 Determined
Cause | Nonconforming Material/Component |
| Action | On March 3, 2026 URGENT VOLUNTARY MEDICAL DEVICE RECALL letters were sent to customers.
Actions to be taken:
IMMEDIATELY:
1. Stop using the devices subject to this recall and share the notification to all users of the deviceswithin your facility immediately.
2. Provide a copy of this recall notification to all sites or clinics to which you have distributed affectedproduct.
3. Remove any affected items/lots from your inventory (whether in labs, Central Supply, Shipping andReceiving or ANY other location).
4. Segregate this product in a secure location for return to AngioDynamics, Inc.
5. Package and Return the Recalled Product. |
| Quantity in Commerce | 4925 units (985 boxes) |
| Distribution | Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, China, Chile, Curacao, Czech Republic, Germany, Ireland, Israel, Italy, Lebanon, Netherlands, New Zealand, Panama, Slovenia, South Africa, Spain, Sweden, Thailand. |
| Total Product Life Cycle | TPLC Device Report |

| 1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes. | |

| 510(K) Database | 510(K)s with Product Code = DQO |