FDA Device recall Z-2166-2021
basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional de…
- FDA Device
- Class II
- terminated
- Published 2021-08-04
On 2021-08-04 the FDA classified a Class II recall of basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to inflate and deflate an angioplasty balloon or other interventional de… by Merit Medical Systems, citing due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2166-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-06-10 |
| Published | 2021-08-04 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Merit Medical Systems |
| Distribution | US |
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.
Reason
Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.
Identifiers
| code_info | Catalog Number: IN3130 UDI: 00884450440179; 00884450510155; Lot Numbers: H1862928; H1896261; H1923761; H1929106…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; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2166-2021%22
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