10Fore™ Hemostasis Valve
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| 10Fore™ Hemostasis Valve | H3098829 | MAPTEN452 |
| 10Fore™ Hemostasis Valve | H3111162 | MAPTEN452 |
| 10Fore™ Hemostasis Valve | H3098831 | MAPTEN4 |
| 10Fore™ Hemostasis Valve | H3111155 | MAPTEN4 |
| 10Fore™ Hemostasis Valve | H3152503 | MAPTEN4 |
| 10Fore™ Hemostasis Valve | H3155611 | MAPTEN4 |
| 10Fore™ Hemostasis Valve | H3186901 | MAPTEN4 |
| 10Fore™ Hemostasis Valve | H3076189 | MAPTEN42 |
| 10Fore™ Hemostasis Valve | H3111156 | MAPTEN42 |
| 10Fore™ Hemostasis Valve | H3155614 | MAPTEN42 |
| 10Fore™ Hemostasis Valve | H3173674 | MAPTEN42 |
| 10Fore™ Hemostasis Valve | H3152504 | MAPTEN42 |
Issue
Merit Medical became aware of a manufacturing quality concern during routine QA inspection of a 10Fore™ Hemostasis Valve work order in February 2025. Initial defect assessments determined the observed damage to the silicone quad ring was due to the manual nature of operator handling and subsequent placement/positioning of the quad ring into the corresponding y body. If the ring is not gently manipulated and/or not fully seated in its intended position during the pressing process it can become deformed or otherwise damaged.
Recall start date: July 25, 2025
Additional information
Details
Merit Medical Systems Inc.
1600 West Merit Parkway, South Jordan, Utah, United States, 84095
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