Z-2166-2021Class II

basixALPHA Inflation Device 30 atm/bar 20 mL -

Name: Z-2166-2021 basixALPHA Inflation Device 30 atm/bar 20 mL -
Creator: Merit Medical Systems, Inc.
Published: 2021-06-10
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2021-06-10 / Terminated / root cause: design

FDA source

Merit Medical Systems, Inc. began a recall of 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... on 2021-06-10. FDA classified it as Class II and gives the reason as "Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2166-2021
Classification: Class II
Status: Terminated
Initiated: 2021-06-10
Posted: 2021-07-29
Terminated: 2024-05-15
Recalling firm: Merit Medical Systems, Inc.
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.
Product code: PTM Syringe, Balloon Inflation, Exempt
Reason for recall: Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.
Root cause tag: design
FDA root cause: Device Design
Action: 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 [email protected] 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.
Quantity in commerce: 7,211 devices
Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of AL, AZ, CA, CO, DE, FL, GA, ID, IL IN, KS, LA, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, WA, WI, WV, and WY. The countries of Australia, Austria, China, Denmark, Finland, France, Germany, Israel, Japan, Kenya, Kyrgyzstan, Netherlands, New Zealand, Norway, Qatar, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates and United Kingdom.
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2166-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2166-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-04	2021-07-29

Product code PTM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)