FDA Recalls Merit Pursue Microcatheter Due to Sterility Concerns
Merit Medical Systems is recalling Merit Pursue Microcatheter devices distributed worldwide because sterility cannot be guaranteed. Patients should contact their healthcare provider.
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 a Class II recall of an invasive medical device where the critical safety attribute—sterility—cannot be guaranteed. The loss of sterility on a microcatheter poses a direct risk of infection to patients, meeting the criteria for a high-severity risk-of-harm product with no reported illnesses yet identified.
Plain-English summary
Merit Medical Systems, Inc. is recalling Merit Pursue Microcatheter and infusion system devices because their sterility cannot be guaranteed. The recall affects 59 units with multiple reference numbers and lot numbers across specific manufacturing batches.
Affected devices were distributed nationwide in the United States (Alabama, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Minnesota, Missouri, New Hampshire, New Jersey, Nevada, New York, Utah, and Wisconsin) and internationally to Argentina, Australia, Belgium, China, France, Germany, Guam, Hong Kong, Italy, Mexico, the Netherlands, and Switzerland.
Patients who have received these microcatheters or infusion system devices should contact their healthcare provider immediately for guidance. Healthcare providers and patients with questions can reach Merit Medical Systems for additional information about the specific lot numbers involved: H2769793, H2767389, H2750582, H2750587, and H2765980.
The recalled product
- Product
- Merit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A, 29HC20150SN/A, 29HC20150ST, CE 2797, STERILEEO, Rx ONLY
- Manufacturer
- Merit Medical Systems, Inc.
- Hazard
- sterility-loss
- contamination
Distribution
Distributed nationwide across the United States.
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