Merit Maestro Microcatheter Sterility Recall, 717 Units Distributed Worldwide
Merit Medical Systems is recalling 717 units of Merit Maestro Microcatheters because their sterility cannot be guaranteed. Non-sterile devices could introduce infection when used in medical procedures.
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 an FDA Class II sterility failure in invasive medical devices. While non-sterile catheters could introduce serious infection, no illnesses or injuries have been reported. Per FDA guidance, theoretical hazards without reported harm are scored at maximum as High.
Plain-English summary
Merit Medical Systems, Inc. is recalling Merit Maestro Microcatheters due to sterility assurance failures. The sterility of the recalled microcatheters and infusion system devices cannot be guaranteed, which could result in contamination or infection if the devices are used in medical procedures.
The recall affects 717 units distributed worldwide, including throughout the United States and in multiple countries. U.S. distribution included facilities in Alabama, Arizona, California, Colorado, Connecticut, Florida, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maryland, Minnesota, Missouri, New Hampshire, New Jersey, Nevada, New York, Utah, and Wisconsin. International distribution included facilities in Argentina, Australia, Belgium, China, France, Germany, Guam, Hong Kong, Italy, Mexico, Netherlands, and Switzerland.
Healthcare facilities that have received these recalled devices should verify receipt against the specific reference numbers and lot numbers listed in the FDA recall notice and should not use the recalled units. Facilities should contact Merit Medical Systems or the FDA for return and replacement instructions.
The recalled product
- Product
- Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC21130ST/B, 28MC2115045/B, 28MC2115045/C, 28MC21150SN/B, 28MC21150ST/B, 28MC2411045/D, 28MC24110SN/D, 28MC24110ST/D, 28MC2413045/D, 28MC24130SN/F…
- Manufacturer
- Merit Medical Systems, Inc.
- Affected units
- 717
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 (9)
- Ref:28MC2111045/B - Lot # H2775120 - UDI: 00884450335215
- Ref: 28MC21110ST/B- Lot # H2750697 and H2775121 - UDI: 00884450335239
- Ref:28MC2113045/B- Lot # H2750699
- H2763805
- H2775122 - UDI: 00884450335246
- Ref:28MC21130SN/CNB- Lot # H2747446-UDI:00884450335253
- H2766011
- H2769993
- H2765976 and H2770087 - UDI: 00884450358160
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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