CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B,...
FDA Device Recall #Z-0137-2023 — Class II — August 3, 2022
Recall Summary
| Recall Number | Z-0137-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 3, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Merit Medical Systems, Inc. |
| Location | South Jordan, UT |
| Product Type | Devices |
| Quantity | 1822 |
Product Description
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, CORCA1610/B, CORCA1610S/B, CORCA1615/A, CORCA1615/B, CORCA1615S/B, CORCA1810B/A, CORCA1810B/B, CORCA1810SB/A, CORCA1810SB/B, CORCA1815B/A, CORCA1815B/B, CORCA1815SB/A, CORCA1815SB/B, CORCA1820B/A, CORCA1820B/B, CORCA1820SB/A, CORCA1820SB/B, CORCA1825B/A, CORCA1825SB/B, CORCA2010B/A, CORCA2010B/B, CORCA2010SB/A, CORCA2010SB/B, CORCA2015B/A, CORCA2015B/B, CORCA2015SB/A, CORCA2015SB/B, CORCA2020B/A, CORCA2020B/B
Reason for Recall
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.
Distribution Pattern
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 Emirates, Spain, Sweden, Norway, Jordan, Australia, Germany, Austria, Italy, United Kingdom, France, Canada, Mexico, Puerto Rico, Chile, Reunion, Belgium, Switzerland, Japan, South Africa, Qatar, Russian Federation, Hungary, Thailand, Namibia, Colombia, New Zealand, Netherlands, Saudi Arabia, Costa Rica, Oman, Cyprus, Slovenia, Croatia, China.
Lot / Code Information
Catalog Code-Lot/UDI: CORA1610/B-I2075805, I2093969, I2101330, I2124107, I2233501, I2286703, I2325899/00884450476192; CORA1610S/B-I2138037, I2352845/00884450476222; CORA1615/B-H1408433, H1462686, I1863888, I2127448, I2170247, I2259080/00884450476253; CORA1810/A-H1715532, H1756745, H1767115, H1771762, H1776067, H1784861, H1800979, H1808121, H1825693/00884450316405; CORA1810/B-I1781878, I1818817, I1837234, I1843704, I1855418, I1866359, I1952354, I1958525, I1971876, I1990075, I1998862, I2043630, I2070249, I2075810, I2093993, I2114550, I2116110, I2124108, I2127451, I2137798, I2155289, I2206046, I2243065, I2263876, I2263877, I2282032, I2291981, I2297372, I2385808/00884450476116; CORA1810S/B-I1877912, I1877916, I1902603, I1971867, I1998851, I2033178, I2070341, I2075809, I2124109, I2127455, I2170248, I2370120/00884450477625; CORA1815/A-H1733631, H1734003, H1739133, H1756746, H1771770, H1795481, H1800980, H1807701/00884450316412; CORA1815/B-I1821113, I1838444, I1855417, I1920169, I1920191, I1946564, I1952362, I1989173, I1990074, I2033176, I2070349, I2075808, I2093995, I2114555, I2116111, I2124110, I2127456, I2137805, I2170249, I2201366, I2233502, I2263885, I2269827, I2325901, I2349440/00884450477618; CORA1815S/A-H1756747, H1784863/00884450316528; CORA1815S/B-I1869477, I1874063, I2075806, I2114557, I2127463, I2325902/00884450477601; CORA1820/A-H1375632, H1382959, H1718587, H1734004, H1739135, H1756748, H1762731, H1771773, H1771881, H1784864, H1815597/00884450316429; CORA1820/B-I1823060, I1971866, I2114564, I2137809, I2170250, I2303053, I2385809/00884450477595; CORA1820S/A-H1739136, H1790841/00884450316535; CORA1825/A-H1749790, H1762724, H1808022, H1815598/00884450316436; CORA1825/B-I1843706, I1958504, I2234738, I2239042/00884450477571; CORA1825S/A-H1790845/00884450316542; CORA2010/A-H1784872, H1815600/00884450316443; CORA2010/B-I1863885, I2201378, I2206047, I2237417/00884450477557; CORA2010S/A-H1692834, H1776070/00884450316559; CORA2015/A-H1795483/00884450316450; CORA2015/B-I1823512, I1860367, I1962715, I2140223, I2243072, I2283710, I2303054, I2330668/00884450477526; CORA2015S/A-H1697709, H1771823, H1784884, H1795484/00884450316566; CORA2020/A-H1815606/00884450316467; CORA2020/B-I1781880, I1971845, I2007291, I2228365/00884450477496; CORCA1410/A-H1639707/00884450316580; CORCA1410/B-I2244480, I2384730/00884450476284; CORCA1415/A-, H1776075/00884450316597; CORCA1415/B-I2191846, I2286700, I2318838, I2325906/00884450476314; CORCA1610/A-H1428538, H1714401/00884450316603; CORCA1610/B-I1971855, I1998714, I2114620, I2170251, I2201382, I2233505, I2318858, I2343154/00884450476338; CORCA1610S/B-I1874064, I2010416/00884450476345; CORCA1615/A-H1703701/00884450316610; CORCA1615/B-I1845903, I1888547, I1920175, I1962716, I1998860, I2103685, I2137221, I2137223, I2170252, I2237426, I2286696, I2297374, I2303056, I2330680, I2385810/00884450476352; CORCA1615S/B-I2114626, I2246748/00884450476369; CORCA1810B/A-H1718595, H1734012, H1749798, H1756750, H1771846, H1776080, H1782158, H1790850, H1800985, H1808042/00884450316627; CORCA1810B/B-I1814729, I1838323, I1843705, I1845904, I1869474, I1877911, I1888548, I1902611, I1920161, I1946561, I1946566, I1958530, I1962714, I1990098, I1990104, I1998856, I2025072, I2070266, I2070374, I2093853, I2101369, I2104884, I2114628, I2114714, I2114715, I2116109, I2124195, I2127511, I2150947, I2150948, I2150949, I2159264, I2165513, I2165514, I2201386, I2221444, I2286695, I2303061, I2330685, I2343157, I2385811/00884450476376; CORCA1810SB/A-H1733634, H1800986/00884450316801; CORCA1810SB/B-I1862927, I1920180, I2033140, I2114634, I2233507, I2303065, I2330686/00884450476383; CORCA1815B/A-H1476238, H1608916, H1714408, H1734014, H1734016, H1743880, H1749800, H1749802, H1762717, H1771848, H1776082, H1782159, H1790847, H1795487, H1807720/00884450316634; CORCA1815B/B-I1827256, I1838326, I1843709, I1845905, I1860329, I1860365, I1877914, I1888549, I1902608, I1902609, I1920165, I1920186, I1946560, I1946567, I1952368, I1958533, I1962702, I1971860, I1971861, I1990097, I1990103, I2007293, I2058398, I2061959, I2062021, I2065393, I2075813, I2075839, I2094063, I2098053, I2102664, I2105077, I2114651, I2114652, I2124197, I2127514, I2127515, I2150950, I2150952, I2159275, I2159276, I2170253, I2201393, I2217616, I2281931, I2318869, I2330533, I2330692, I2336279, I2343163, I2349439, I2357134, I2385813, I2385814/00884450476390; CORCA1815SB/A-H1714409, H1743881, H1756752, H1762715/00884450316740; CORCA1815SB/B-I1838328, I1845906, I1877918, I1958536, I2061956, I2075811, I2093850, I2094072, I2233509, I2325909, I2330694, I2399997/00884450476406; CORCA1820B/A-H1718598, H1733635, H1734019, H1749803, H1756754, H1762714, H1771883, H1776084, H1790851, H1807721/00884450316641; CORCA1820B/B-I1827257, I1845907, I1902605, I1902607, I1920166, I1946562, I1971929, I1990094, I1998850, I1998858, I2007294, I2094075, I2103689, I2114708, I2124200, I2127516, I2150980, I2159282, I2159283, I2233510, I2286679, I2343166, I2352856/00884450476413; CORCA1820SB/A-H1733637/00884450316757; CORCA1820SB/B-I2137856, I2325911/00884450476437; CORCA1825B/A-H1718603/00884450316658; CORCA1825B/B-I1946563, I2137863, I2201410, I2265757, I2325913/00884450476451; CORCA1825SB/B-I2156607/00884450476468; CORCA2010B/A-H1445217, H1703705, H1708690, H1718606, H1718607, H1749806, H1762738, H1771884, H1807725, H1815614/00884450316665; CORCA2010B/B-I18210937/I1845908, I1862929, I1874055, I1877913, I1958538, I1971927, I1990070, I2075817, I2094080, I2114709, I2127519, I2170256, I2217622, I2325922/00884450476475; CORCA2010SB/A-H1749807/00884450316771; CORCA2010SB/B-I1874058, I1902604, I1998852, I2122957, I2233511/00884450477632; CORCA2015B/A-H1624841, H1639711, H1657959, H1697713, H1708691, H1714416, H1718609, H1733639, H1734020, H1743882, H1749810, H1771851, H1776086, H1784915, H1790853, H1807727/00884450316672; CORCA2015B/B-I1827258, I1855420, I1862900, I1873128, I1874060, I1888545, I1902614, I1920156, I1952374, I1990072, I1998863, I2070355, I2080473, I2094083, I2114711, I2116112, I2124201, I2127521, I2137868, I2159284, I2191857, I2246760, I2263980, I2287299, I2303068, I2352880, I2370145/00884450477649; CORCA2015SB/A-H1662694, H1733642, H1739148, H1771853, H1776087, H1807729, H1815615/00884450316788; CORCA2015SB/B-I1827270, I1845912, I1862899, I2080472, I2170257, I2201414/00884450477656; CORCA2020B/A-H1662697, H1692861, H1708693, H1718613, H1756755, H1771854, H1776088, H1790855, H1807731/00884450316689; CORCA2020B/B, I1827272, I1845913, I1869475, I1874065, I1877915, I1971882, I1990071, I2070361, I2075814, I2114712, I2151307, I2170259, I2201416, I2330716/00884450477663; CORCA2020SB/B-I2263985, I2297377/00884450477670;
Other Recalls from Merit Medical Systems, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1578-2026 | Class I | DuraMax Chronic Hemodialysis Catheter, REF: H78... | Feb 13, 2026 |
| Z-1576-2026 | Class I | ProGuide Chronic Dialysis Catheters, REF: DC014... | Feb 13, 2026 |
| Z-1577-2026 | Class I | 16F Dual Valved Splittable Sheath Introducer (b... | Feb 13, 2026 |
| Z-1575-2026 | Class I | CentrosFLO Hemodialysis Catheters, REF: CENFP15... | Feb 13, 2026 |
| Z-1579-2026 | Class I | BioFlo DuraMax Catheter, REF: H965103028011/A, ... | Feb 13, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.