Merit basixCOMPAK™, PhD™ Hemostasis Valve, and basixSKY™ Inflation Syringe
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
basixCOMPAK™ MAP802 |
I3161210 |
IN4802 |
basixCOMPAK™ MAP802 |
I3161211 |
IN4802 |
PhD™ Hemostasis Valve |
I3146099 |
MAP801 |
PhD™ Hemostasis Valve |
I3186946 |
MAP801 |
PhD™ Hemostasis Valve |
I3219783 |
MAP802 |
PhD™ Hemostasis Valve |
I3209935 |
MAP802 |
PhD™ Hemostasis Valve |
I3215926 |
MAP802 |
PhD™ Hemostasis Valve |
I3192937 |
MAP802 |
PhD™ Hemostasis Valve |
I3215925 |
MAP802 |
PhD™ Hemostasis Valve |
I3129726 |
MAP802 |
PhD™ Hemostasis Valve |
I3129725 |
MAP802 |
PhD™ Hemostasis Valve |
I3219784 |
MAP800 |
PhD™ Hemostasis Valve |
I3206933 |
MAP800 |
PhD™ Hemostasis Valve |
I3219792 |
MAP800 |
PhD™ Hemostasis Valve |
I3186951 |
MAP800 |
PhD™ Hemostasis Valve |
I3191334 |
MAP800 |
Custom Procedure Kit - Stroke Kit |
T3163727 |
K12T-10798A |
Custom Procedure Kit - Stroke Kit |
T3217266 |
K12T-10798A |
basixSKY™ Inflation Syringe MAP802 |
H3155575 |
SKY1802 |
basixSKY™ Inflation Syringe MAP802 |
H3141576 |
SKY1802 |
basixSKY™ Inflation Syringe MAP802 |
H3155576 |
SKY1802 |
basixSKY™ Inflation Syringe MAP802 |
H3155577 |
SKY1802 |
basixSKY™ Inflation Syringe MAP802 |
H3079946 |
SKY1802 |
basixSKY™ Inflation Syringe MAP802 |
H3141577 |
SKY1802 |
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
Additional information
Details
Merit Medical Systems Inc.
1600 West Merit Parkway, South Jordan, Utah, United States, 84095
Get notified
Receive emails about new and updated recall and safety alerts.