Z-0138-2023Class II

CorVocet Biopsy System, Catalog Code: CORA1410/B, CORA1410S/B, CORA1415/B, CORA1615S/B, CORA2010S/B...

Name: Z-0138-2023 CorVocet Biopsy System, Catalog Code: CORA1410/B, CORA1410S/B, CORA1415/B, CORA1615S/B, CORA2010S/B...
Creator: Merit Medical Systems, Inc.
Published: 2022-08-03
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2022-08-03 / Open, Classified / root cause: manufacturing process

FDA source

Merit Medical Systems, Inc. began a recall of CorVocet Biopsy System, Catalog Code: CORA1410/B, CORA1410S/B, CORA1415/B, CORA1615S/B, CORA2010S/B, CORCA1410S/B, CORCA1410S/CNB, CORCA1415S/B, CORCA1610/CNB... on 2022-08-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0138-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-08-03
Posted: 2022-10-27
Recalling firm: Merit Medical Systems, Inc.
Product: CorVocet Biopsy System, Catalog Code: CORA1410/B, CORA1410S/B, CORA1415/B, CORA1615S/B, CORA2010S/B, CORCA1410S/B, CORCA1410S/CNB, CORCA1415S/B, CORCA1610/CNB, CORCA1615S/CNB, CORCA1810SB/CNB, CORCA1815SB/CNB, CORCA1820SB/CNB, CORCA2015SB/CNB, CORCA2020SB/CNB
Product code: KNW Instrument, Biopsy
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 2894
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 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.
Product codes and lots: Catalog Code-Lot (OUS Distribution Only): CORA1410/B- I2206909, I2318475, I2291980, I2286704; CORA1410S/B- I2206888; CORA1415/B- I2213361; CORA1615S/B- I2114518, H1517631, H1715532, H1756745, H1767115, H1771762, H1776067, H1784861, H1800979, H1808121, H1825693, I1781878, I1818817, I1837234, I1843704, I1855418, I1866359, I1952354, I1958525, I1971876, I1990075, I1998862, I2043630, I2070249, I2075810; CORA2010S/B- I2010414; CORCA1410S/B- I2259093; CORCA1410S/CNB- I2305358; CORCA1415S/B- I2210950; CORCA1610/CNB- I2291983; CORCA1615S/CNB- I2330683; CORCA1810SB/CNB- I2305359; CORCA1815SB/CNB- I2170254, I2205164; CORCA1820SB/CNB- I2325912; CORCA2015SB/CNB- I2318903, I2325926; CORCA2020SB/CNB- I2320880

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0138-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0137-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-02	2022-10-27
Z-0138-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-02	2022-10-27

Product code KNW

K180450Class IICorvocet Biopsy SystemMerit Medical Systems, Inc. / cleared 2018-03-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)