Merit Medical Systems recalled 173,645 Allwell Inflation Devices on December 4, 2025. The device handle may detach from the syringe during procedures, posing a high hazard. Healthcare providers and patients should stop using the device immediately.
Inflation device handle may detach from the syringe during procedure.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Merit Medical Systems, Inc. or your healthcare provider for instructions. Notification method: E-Mail
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The Allwell Inflation Device is used in angiographic procedures to inflate balloons within blood vessels. Medical professionals rely on this device for precision during critical cardiovascular interventions.
The inflation device's handle detachment can interrupt procedures, potentially leading to severe complications or inadequate treatment outcomes.
This recall is not part of a broader industry pattern.
Patients and healthcare providers must stop using the device immediately, which may disrupt medical procedures and require alternative solutions.
The lot number can typically be found on the packaging or the device itself.
Expect a refund or replacement process to take approximately 4-6 weeks after initiating the return.
Keep all emails, receipts, and correspondence regarding the recall for your records.
The recalled product is the Allwell Inflation Device for angiographic use, REF: IS-30-A. The affected lot numbers include I2559701, I2563344, and others. The devices were distributed worldwide.
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