Reported Aug 4, 2021 · Terminated
basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or…
Merit Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Merit Medical Systems, Inc. · 1600 W Merit Pkwy · South Jordan, UT · 84095-2416
Is this the product you have?
- basixALPHA Inflation
- Device 30 atm/bar 20 mL - Product UsageUsed to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon
- Lot codes and dates
39 of 39 products
Products covered by this recall Model / number Barcodes Product as published IN313000884450440179UDI: 00884450440179 — 0088445051015500884450510155 — Lot Numbers: H1862928 — H1896261 — H1923761 — H1929106 — H1939255 — H1966485 — H1978295 — H2068264 — H2073193 — H2073247 — H2077173 IN315200884450511220UDI: 00884450511220 Lot Numbers: H1896262 — H1909581 — H1923762 — H1929107 — H1978299 — H2007415 — H2031599 - Amount recalled
- 7,211 devices
Where it was sold
Why it was recalled
Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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