Home / Recalls / Merit Medical Systems, Inc. / Z-2166-2021

Z-2166-2021 Class II Terminated

Recalled by Merit Medical Systems, Inc. — South Jordan, UT

FDA device recall Z-2166-2021 was initiated by Merit Medical Systems, Inc. on June 10, 2021 and is designated Class II. Reason for recall: Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn. The recall status is terminated (terminated May 15, 2024). Affected quantity: 7,211 devices.

Recall Details

Product Type
Devices
Report Date
August 4, 2021
Initiation Date
June 10, 2021
Termination Date
May 15, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7,211 devices

Product Description

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 for Recall

Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.

Distribution Pattern

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.

Code Information

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;

Other recalls by Merit Medical Systems, Inc.

  • Z-2517-2026 Class II — Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 0088445052 (May 8, 2026)
  • Z-2003-2026 Class II — Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY (April 2, 2026)
  • Z-2002-2026 Class II — Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY (April 2, 2026)
  • Z-2004-2026 Class II — Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY (April 2, 2026)
  • Z-1578-2026 Class I — DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H7 (February 13, 2026)
  • Z-1577-2026 Class I — 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-0 (February 13, 2026)
  • Z-1579-2026 Class I — BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU (February 13, 2026)
  • Z-1576-2026 Class I — ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419 (February 13, 2026)
  • Z-1575-2026 Class I — CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENF (February 13, 2026)
  • Z-1129-2026 Class II — Allwell Angioplasty Pack REF: IS-30-B1/B (December 4, 2025)

FDA data resources