Medtronic Endurant II Stent Graft System Recalled for Incorrect Assembly
Medtronic is recalling 3 Endurant II/IIs Stent Graft Systems due to an incorrect stentstop assembly component in the delivery system. The defective devices use an 18-French assembly instead of the required 20-French component.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The defect represents a risk of harm to patients if the device is deployed, but actual injury has not been documented. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, corresponding to a High (3) severity score.
Plain-English summary
Medtronic Vascular, Inc. is recalling 3 units of the Endurant II/IIs Stent Graft System (model ETBF3216C145E) due to a manufacturing defect. The recalled devices contain an incorrect 18-French stentstop assembly in the delivery system component, when the correct stentstop assembly should be 20-French. This size mismatch could affect proper device function.
The affected devices have serial numbers V30064787, V30064789, and V30064790. These devices were distributed nationwide in the state of Georgia. The stent graft systems are indicated for treatment of vascular aneurysms.
Individuals with these devices or healthcare providers caring for patients with them should verify serial numbers and contact Medtronic Vascular, Inc. for further guidance regarding their specific devices.
The recalled product
- Product
- Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
- Manufacturer
- Medtronic Vascular, Inc.
- Hazard
- assembly-defect
- component-mismatch
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model Number: ETBF3216C145E GTIN: 00613994990983 Serial Numbers: V30064787
- V30064789
- V30064790
Distribution
Distributed nationwide across the United States.
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