medical Class II Updated 2021-04-21

Boston Scientific Corporation recalls MAMBA Flex 135 Microcatheter. Packaged with protective slee

Recalled Product

MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton.

Hazard / Issue

The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UPN: H7493928713540 US (Green); Batches: 26578463 and 26578470; GTIN: 8714729940289; and Expiration Date: 4-Jan-23
View official government recall

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