CorVocet Biopsy System recall due to potential unintended needle ejection
Merit Medical Systems is recalling 2,894 CorVocet Biopsy Systems because misaligned components may cause the needle to eject unexpectedly when triggered outside the body, risking needle stick injuries.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a risk-of-harm product (needle stick injury from unintended needle ejection) where no injuries have been reported in the source text. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Merit Medical Systems, Inc. is recalling 2,894 units of the CorVocet Biopsy System due to a manufacturing defect. The CorVocet Biopsy System is a medical device used to obtain tissue samples during diagnostic procedures.
The systems contain components that are misaligned due to an issue with the manufacturing assembly equipment. This misalignment may cause the needle to eject when triggered outside the patient's body, creating a risk of needle stick injuries to healthcare workers or patients.
Affected devices have been distributed worldwide, including throughout the United States and multiple countries. The FDA classified this recall as Class II. For specific lot numbers, distribution details, and manufacturer instructions, refer to FDA recall Z-0138-2023.
The recalled product
- 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
- Manufacturer
- Merit Medical Systems, Inc.
- Hazard
- needle-stick-injury
- unintended-ejection
- component-misalignment
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed in 42 states:
- AK
- AL
- AR
- AZ
- CA
- CO
- CT
- DE
- FL
- GA
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- MI
- MN
- MO
- MS
- MT
- NC
- ND
- NE
- NH
- NJ
- NV
- NY
- OH
- OK
- OR
- PA
- RI
- SC
- TN
- TX
- UT
- VA
- WA
- WI
- WV
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