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Boston Scientific Cork, Ltd. FDA Recalls
41 recalls on file across devices, 0 of them Class I and 41 still open. Matched by name to BSX.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/105; Material Number: M001195290Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/130; Material Number: M001195440Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/155; Material Number: M001195750Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/155; Material Number: M001195280Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/105; Material Number: M001195260Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/130; Material Number: M001195840Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/130; Material Number: M001195240Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/130; Material Number: M001195340Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/STRAIGHT/1RO/130; Material Number: M001195810Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/130; Material Number: M001195300Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/105; Material Number: M001195230Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/155; Material Number: M001195450Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/STRAIGHT/1RO/130; Material Number: M001195910Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/BERN/1RO/130; Material Number: M001195940Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/155; Material Number: M001195350Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/155; Material Number: M001195420Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/105; Material Number: M001195200Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/155; Material Number: M001195220Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/130; Material Number: M001195410Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/155; Material Number: M001195310Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/130; Material Number: M001195500Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/155; Material Number: M001195250Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/130; Material Number: M001195740Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/FATHOM/027/STRAIGHT/1RO/155; Material Number: M001195720Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/105; Material Number: M001195400Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/155; Material Number: M001195620Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/130; Material Number: M001195610Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/2RO/130; Material Number: M001195670Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/2RO/130; Material Number: M001195660Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/130; Material Number: M001195470Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/155; Material Number: M001195510Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/105; Material Number: M001195430Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/130; Material Number: M001195640Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/155; Material Number: M001195480Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/155; Material Number: M001195650Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/155; Material Number: M001195850Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/130; Material Number: M001195270Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/2RO/130; Material Number: M001195320Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/2RO/155; Material Number: M001195330Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/130; Material Number: M001195210Class IISep 16, 2026The product is defective due to insufficient UV curing of th |
| Direxion Torqueable Microcatheter, NGMC/FATHOM/027/STRAIGHT/1RO/130; Material Number: M001195710Class IISep 16, 2026The product is defective due to insufficient UV curing of th |