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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Affected units
- 59
Distribution
Part of a larger recall action
This product is one of 3 recalled by Merit Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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