Recall Monitor
Health Products

Merit basixCOMPAK™, PhD™ Hemostasis Valve, and basixSKY™ Inflation Syringe

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular, Health products - Medical devices - General hospital and personal use
Product: Merit basixCOMPAK™, PhD™ Hemostasis Valve, and basixSKY™ Inflation Syringe
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalog number
basixCOMPAK™ MAP802I3161210IN4802
basixCOMPAK™ MAP802I3161211IN4802
PhD™ Hemostasis ValveI3146099MAP801
PhD™ Hemostasis ValveI3186946MAP801
PhD™ Hemostasis ValveI3219783MAP802
PhD™ Hemostasis ValveI3209935MAP802
PhD™ Hemostasis ValveI3215926MAP802
PhD™ Hemostasis ValveI3192937MAP802
PhD™ Hemostasis ValveI3215925MAP802
PhD™ Hemostasis ValveI3129726MAP802
PhD™ Hemostasis ValveI3129725MAP802
PhD™ Hemostasis ValveI3219784MAP800
PhD™ Hemostasis ValveI3206933MAP800
PhD™ Hemostasis ValveI3219792MAP800
PhD™ Hemostasis ValveI3186951MAP800
PhD™ Hemostasis ValveI3191334MAP800
Custom Procedure Kit - Stroke KitT3163727K12T-10798A
Custom Procedure Kit - Stroke KitT3217266K12T-10798A
basixSKY™ Inflation Syringe MAP802H3155575SKY1802
basixSKY™ Inflation Syringe MAP802H3141576SKY1802
basixSKY™ Inflation Syringe MAP802H3155576SKY1802
basixSKY™ Inflation Syringe MAP802H3155577SKY1802
basixSKY™ Inflation Syringe MAP802H3079946SKY1802
basixSKY™ Inflation Syringe MAP802H3141577SKY1802

Issue

Merit Medical became aware of a manufacturing defect after an increased number of complaints. Investigation into the issue concluded that the lack of fluorinated silicone in the bleed back seal (the secondary valve) caused by the mix of incorrect silicone during production line influenced the performance of the PhD™ Hemostasis Valve. The lack of silicone was found to prevent the secondary valve from releasing and closing properly. The valve cap potentially would remain depressed causing leakage. Recall start date: July 30, 2025

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