Recall Z-1429-2021— Boston Scientific Corporation

Name: FDA recall Z-1429-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-05

Class II · Terminated

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2021-03-05, terminated 2023-01-05. It names one FDA 510(k) clearance: K190401. 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.. Reason: The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Terminated
Initiated: 2021-03-05
Terminated: 2023-01-05
Firm location: Maple Grove, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K190401 — MAMBA and MAMBA Flex MicrocathetersBoston Scientific Corporation·cleared 2019-03-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.