FDA Medical devices recall ·
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/155 recall
- Recall number
- Z-0252-2027
- Date
- (initiated September 16, 2026)
- Company / brand
- Boston Scientific Cork, Ltd.
Boston Scientific Limited, Business And Technology Park, Model Farm Road, Cork, Ireland - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 860
- Hazard tags
- Laceration
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/155; Material Number: M001195650
Why was it recalled?
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Material Number: M001195650; UDI-DI: 08714729839644; Batch Numbers: 37886794, 37957747, 38022670, 38049176, 38149828, 38175798, 38224585, 38259485, 38323409, 38506199, 38531120, 38560457, 38595646, 38595647, 38745191, 38769968, 38769971, 38916516, 38970729, 38990859, 38990882, 39027327, 39141260, 39189845, 40466132, 40466133, 40466134, 40485781, 40493314, 40502331, 40502332, 40502333, 40504594, 40507434, 40507435, 40531377, 40535710, 40535711, 40537146;
Distribution
Worldwide distribution US Nationwide and territory of Puerto Rico. The countries of Albania, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Mexico, Moldova, Netherlands, New Zealand, Norway, Panama, PERU, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, T¿rkiye, UAE, United Kingdom.
States: Puerto Rico
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0252-2027. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.