Medtronic Intracoronary Shunts: a) ClearView 1.00 mm Intracoronary Shunt, Model Numbers: 31100; b) ClearView 1.25 mm Int
FDA device recall Z-1803-2024 · posted 2024-05-10 · Open, Classified
Recall details
- Recalling firm
- Medtronic Perfusion Systems
- Reason for recall
- Potential for unsealed sterile packing.
- Action taken
- Medtronic issued an Urgent Medical Device Recall notice to its consignees on 03/19/2024 via letter (UPS). The notice explained the issue, potential risk, and requested the consignee identify and return the product. Consignee was directed to forward the notice to all affected parties. For questions, the consignee was directed to contact their Medtronic field representative.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- DWF
- Quantity affected
- 1410 units
- Distribution
- Worldwide distribution.
- Date initiated
- 2024-03-19
- Date posted
- 2024-05-10
- Location
- Brooklyn Park, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNT (K120612) | Medtronic, Inc. | 2012-05-25 |