Merit Medical recalls basixALPHA Inflation Devices 30 atm/bar 20 mL due to risk of handle separation during use. Affected units have specific catalog numbers and lot numbers listed in the recall notice.
Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.
Merit Medical is recalling certain basixALPHA Inflation Devices that may have a handle that separates from the device when withdrawn. This could lead to improper balloon inflation during medical procedures, potentially causing injury.
The handle can separate from the inflation device when it is withdrawn, which may cause the balloon to deflate unexpectedly. This could lead to improper inflation of the angioplasty balloon during medical procedures, potentially causing injury to the patient.
Medical professionals using the device for angioplasty procedures are most at risk. Patients receiving these devices during procedures may also be affected if the device malfunctions.
Check for catalog numbers IN3130, IN3152, or IN3302 with specific lot numbers listed in the recall notice. The product is used to inflate and deflate angioplasty balloons.
Look for lot numbers on the device packaging or label: H1862928, H1896261, H1923761, H1929106, H1939255, H1966485, H1978295, H2068264, H2073193, H2073247, H2077173, and others as listed in the recall.
Reach out to Merit Medical Systems for further assistance or to confirm if your device is affected.
The handle may separate from the inflation device when withdrawn, which could cause the angioplasty balloon to deflate unexpectedly during use.
Check the catalog number and lot number on your device. Affected units have specific catalog numbers (IN3130, IN3152, IN3302) and lot numbers listed in the recall notice.
Check the lot number on your device packaging or label. If it matches the listed numbers, contact Merit Medical for further instructions.
We’ve drafted a message you can send Merit Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2166-2021 — Merit Medical Merit Medical Hello, I own a Merit Medical that is covered by recall Z-2166-2021 from Merit Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
