FDAsafety guidance83% confidence
Thoracic Stent Graft Recall: Bolton Medical Removes Relay Pro System
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (pain) as Comparative Study of SPSIPB vs Thoracic Paravertebral Block for Opioid Reduction.
Regulatory Analysis
Affected grafts may not unclasp from the delivery system. This may require conversion to open surgical repair and can result in patient death.
Supporting Context
- Therapeutic area
- Pain Management · Anesthesia
- Sub-indication
- Pain
Related signal: Comparative Study of SPSIPB vs Thoracic Paravertebral Block for Opioid Reduction