Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/130; Material Number: M001195440
Boston Scientific Cork, Ltd. · 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 microcathe…
- Status
- Ongoing
- City
- Cork
- Country
- Ireland
- Classification
- Class II
- Product type
- Devices
- Event ID
- 99906
- Recalling firm
- Boston Scientific Cork, Ltd.
- Address 1
- Boston Scientific Limited, Business And Technology Park, Model Farm Road
- Postal code
- N/A
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Recall number
- Z-0243-2027
- Product description
- Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/130; Material Number: M001195440
- Product quantity
- 620
- Recall initiation date
- 20260916
- Center classification date
- 20261022
- Report date
- 20261028
- 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.
- 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.
- Code info
Material Number: M001195440; UDI-DI: 08714729839514; Batch Numbers: 38181961, 38198832, 38224582, 38259483, 38324070, 38460469, 38560455, 38560456, 38595654, 38649857, 38745194, 38745195, 38810586, 38810591, 38904805, 39092267, 39092272, 39143222, 40470259, 40478976, 40478977, 40492318, 40497671, 40497858, 40502038, 40502039;