Z-1866-2026Class II
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH; Catalog No.: 10714021...
Boston Scientific Corporation / initiated 2026-03-03 / Open, Classified / root cause: manufacturing process
Angiodynamics, Inc. began a recall of Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH; Catalog No.: 10714021; Product/UPN No.: H787107140215 (Box)... on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1866-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Boston Scientific Corporation
- Product
- Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH; Catalog No.: 10714021; Product/UPN No.: H787107140215 (Box), H787107140210 (Pouch); Box Quantity: 5 pouches;
- Product code
- DQO Catheter, Intravascular, Diagnostic
- 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.
- Root cause tag
- manufacturing process
- FDA root 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
- 615 units (123 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.
- Product codes and lots
- SOFT-VU KMP 4F X 100CM 038 NB 0SH; Catalog No.: 10714021; Product/UPN No.: H787107140215 (Box), H787107140210 (Pouch); UDI-DI: 25051684007952(Box), 15051684007955(Pouch); Lot No.: A2525059, A3725003, A3725004;
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1856-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1857-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1858-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1859-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1860-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1861-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1862-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1863-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1864-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1865-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1866-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1867-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1868-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1869-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1870-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1871-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1872-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1873-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1874-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1875-2026 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
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