Recall Z-0137-2023 ยท KNW Instrument, Biopsy
Merit Medical Systems, Inc.
CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B, CORA1810S/B, CORA1815/A, CORA1815/B, CORA1815S/A, CORA1815S/B, CORA1820/A, CORA1820/B, CORA1820S/A, CORA1825/A, CORA1825/B, CORA1825S/A, CORA2010/A, CORA2010/B, CORA2010S/A, CORA2015/A, CORA2015/B, CORA2015S/A, CORA2020/A, CORA2020/B, CORCA1410/A, CORCA1410/B, CORCA1415/A, CORCA1415/B, CORCA1610/A, CO
| Date | Oct 27, 2022 (initiated Aug 3, 2022) |
| Status | Open, Classified |
| Reason | Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly equipment, which may lead to the needle ejecting when triggered outside the body, which may result in user or patient needle stick injury. |
| Root cause | Process change control |
| Action | On 8/3/2022, recall notices were mailed to customers who were asked to do the following: 1) Identify affected devices, quarantine, discontinue use and distribution, and return to the recalling firm. 2) If product was further distributed, share the recall notice with these customers/users. 3) Complete and return the customer response form. Customers with questions can contact Customer Service at 801-208-4381, 6AM-6PM, Mon-Fri. |
| Quantity | 1822 |
| Distribution | Worldwide distribution - US National distribution including in the states of FL, IL, OH, PA, CA, WI, VA, AZ, AR, MS, TN, MO, MA, MI, NY, NE, TX, WA, MN, LA, DE, IN, AL, NJ, OR, MD, GA, CT, OK, UT, KS, NC, CO, KY, WV, AK, NV, RI, SC, ND, NH, MT and the countries of Finland, Denmark, United Arab Emira |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180450 | Corvocet Biopsy System Merit Medical Systems, Inc., Mar 12, 2018 |