16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | High |
| Status | ongoing |
| Recall date | February 13, 2026 |
| Reported | April 01, 2026 |
| Recalling firm | Merit Medical Systems, Inc. |
| Country / region | United States UT |
Hazard
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.
Affected products
- 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B
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