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SpyGlass™ Retrieval Basket

BOSTON SCIENTIFIC CORPORATION · Model M00546550 · UDI-DI 08714729965886

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10
510(k) clearances
847
Adverse events (5 deaths)
11
Recalls
41
Facilities

Description

Retrieval Basket

Recalls

DateFirmReason
2026-03-05Cook IncorporatedProducts from the affected device lots were labeled with expiration dates that exceed the true shelf life.
2026-03-05Cook IncorporatedProducts from the affected device lots were labeled with expiration dates that exceed the true shelf life.
2009-01-08Boston Scientific CorpThe ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the package and may cause the latex retrieval balloon to become brittle and to
2009-01-08Boston Scientific CorpThe ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the package and may cause the latex retrieval balloon to become brittle and to
2009-01-08Boston Scientific CorpThe ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the package and may cause the latex retrieval balloon to become brittle and to
2006-05-19Boston Scientific CorpLack of assurance of sterility, as the sterile barrier may fail.
2006-05-19Boston Scientific CorpLack of assurance of sterility, as the sterile barrier may fail.
2006-05-19Boston Scientific CorpLack of assurance of sterility, as the sterile barrier may fail.
2006-05-19Boston Scientific CorpLack of assurance of sterility, as the sterile barrier may fail.
2006-05-19Boston Scientific CorpLack of assurance of sterility, as the sterile barrier may fail.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.