—#188062

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.

FDA product code: PTM — Syringe, Balloon Inflation, Exempt
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: 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;

Why it was recalled

Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Merit Medical Systems, Inc.
Address: 1600 W Merit Pkwy South, Jordan, Utah 84095-2416

Distribution

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.

Timeline

Recall initiated: 2021-06-10
Terminated: 2024-05-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188062. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.