medical Class II Updated 2021-04-21

Boston Scientific Corporation recalls MAMBA Microcatheter. Packaged with protective sleeve over c

Recalled Product

MAMBA 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: MAMBA 135 CM US microcatheter: UPN: H7493928713500; Batch: 26578155; GTIN: 8714729940241; and Expiration Date: 4-Jan-23 MAMBA 135 CM OUS microcatheter: UPN: H7493928713520; Batch: 26578465; GTIN: 8714729940265; and Expiration Date: 4-Jan-23

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