Recall Z-2166-2021 ยท PTM Syringe, Balloon Inflation, Exempt
Merit Medical Systems, Inc.
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.
| Date | Jun 10, 2021 |
| Status | Terminated |
| Reason | Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn. |
| 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. |
| Quantity | 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, K |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.