- Recalling firm
- Boston Scientific Cork, Ltd.
- Reason for recall
- 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.
- Affected products (lot / model / serial)
- Material Number: M001195210; UDI-DI: 08714729839323; Batch Numbers: 37914435, 37914436, 37956674, 37981343, 37981344, 38022632, 38022633, 38022634, 38149673, 38181211, 38224528, 38259475, 38259476, 38290713, 38290714, 38290715, 38290716, 38290717, 38399232, 38446223, 38479515, 38506196, 38530446, 38530447, 38629332, 38629333, 38647617, 38647618, 38649501, 38649508, 38687327, 38708440, 38708441, 38745184, 38769513, 38769514, 38934430, 39189795, 39189798, 40466471, 40466472, 40482683, 40482684, 40482685, 40487838, 40487839, 40487900, 40487954, 40487955, 40487956, 40487957, 40501048, 40501049, 40514122, 40514123, 40514222, 40514223, 40533342, 40533344, 40536165, 40536166;
- Units affected
- 2547
- Distribution pattern
- 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.
- Firm location
- Cork, Ireland
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-0224-2027
- Recall initiated
- September 16, 2026
- FDA classification date
- October 22, 2026
- FDA report date
- October 28, 2026
- FDA event ID
- 99906
- Last updated on HTM Vibe
- November 3, 2026
