Recall Monitor
Health ProductsType I recall

10Fore™ Hemostasis Valve

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: 10Fore™ Hemostasis Valve
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type I
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Products

Affected productsLot or serial numberModel or catalog number
10Fore™ Hemostasis ValveH3098829MAPTEN452
10Fore™ Hemostasis ValveH3111162MAPTEN452
10Fore™ Hemostasis ValveH3098831MAPTEN4
10Fore™ Hemostasis ValveH3111155MAPTEN4
10Fore™ Hemostasis ValveH3152503MAPTEN4
10Fore™ Hemostasis ValveH3155611MAPTEN4
10Fore™ Hemostasis ValveH3186901MAPTEN4
10Fore™ Hemostasis ValveH3076189MAPTEN42
10Fore™ Hemostasis ValveH3111156MAPTEN42
10Fore™ Hemostasis ValveH3155614MAPTEN42
10Fore™ Hemostasis ValveH3173674MAPTEN42
10Fore™ Hemostasis ValveH3152504MAPTEN42

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

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