Merit Medical Systems, Inc. basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.
Brand
Merit Medical Systems, Inc.
Lot Codes / Batch Numbers
Catalog Number: IN3130 UDI: 00884450440179, 00884450510155, Lot Numbers: H1862928, H1896261, H1923761, H1929106, H1939255, H1966485, H1978295, H2068264, H2073193, H2073247, H2077173, Catalog Number: IN3152 UDI: 00884450511220 Lot Numbers: H1896262, H1909581, H1923762, H1929107, H1978299, H2007415, H2031599, H2068265, H2073248, H2077175, H2084368, Catalog Number: IN3302 UDI: 00884450511305 Lot Numbers: H1896263, H1966489, Catalog Number: IN3802 UDI: 00884450511510 Lot Numbers: H18962650, H1939259, H1966490, H1973390, H1978305, H1993118, H2001426, H2007417, H2012534, H2031601, H2073198, H2073249, H2077176
Products Sold
Catalog Number: IN3130 UDI: 00884450440179; 00884450510155; Lot Numbers: H1862928; H1896261; H1923761; H1929106; H1939255; H1966485; H1978295; H2068264; H2073193; H2073247; H2077173; Catalog Number: IN3152 UDI: 00884450511220 Lot Numbers: H1896262; H1909581; H1923762; H1929107; H1978299; H2007415; H2031599; H2068265; H2073248; H2077175; H2084368; Catalog Number: IN3302 UDI: 00884450511305 Lot Numbers: H1896263; H1966489; Catalog Number: IN3802 UDI: 00884450511510 Lot Numbers: H18962650; H1939259; H1966490; H1973390; H1978305; H1993118; H2001426; H2007417; H2012534; H2031601; H2073198; H2073249; H2077176;
Merit Medical Systems, Inc. is recalling basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angiopl due to Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.
Recommended Action
Per FDA guidance
On 06/08/2021, the firm sent an "URGENT PRODUCT RECALL NOTICE" initially via an email communication and then followed up with a hardcopy letter via FedEx overnight on 06/10/2021. The communication and letter informed customers that due to a design defect the handle of the inflation device may separate from the syringe during use, which may result in a delay in procedure. Customers are instructed to: 1. Please immediately determine if any of the devices identified in the attached Customer Response Form (CRF) are within their facility, quarantine them, and discontinue use and distribution. 2. Ensure that applicable personnel within their organization are made aware of this recall. 3. If the product has been further distributed to other facilities, institutions, or manufacturers, ensure this notice is immediately shared with them and note the quantity distributed on the CRF. Additional distribution details may be required by health authorities. 4. Fill out, scan, and email the completed CRF to Customer Service at response@merit.com within 10 business days. All affected product shipped must be accounted for on the CRF. 5. Immediately return all affected lots in their possession to the Recalling Firm, per the instructions in the attached CRF. For any question contact the Recalling Firm's Representative or Customer Service at 801-208-4381 Monday thru Friday 6:00 am to 6 pm MDT.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026