Skip to content

basixALPHA recallZ-2166-2021 · Merit Medical Systems, Inc. · initiated Jun 10, 2021

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Merit Medical Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-2166-2021
Status
Terminated
Initiated by the company
Jun 10, 2021
Recalling firm
Merit Medical Systems, Inc.
Quantity
7,211 devices
Product code
PTM
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 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.

Code information (models, lots, serial 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;

Devices named in this recall

5 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page