# FDA recall Z-1429-2021

> **Boston Scientific Corporation** · Class II · device recall initiated 2021-03-05.

## 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 for recall

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

## Distribution

Distributed nationwide to AL, AR, AZ, CO, FL, GA, IA, IL,   KY, LA, MI, MN, MO, MS, NC, ND, NV, NY, OK, OH, PR, SC, TN, VA, WA, WI and internationally to Belgium, France, Great Britain, Israel, Italy, Lithuania, Netherlands, Poland, Puerto Rico, Switzerland

## Key facts

- **Recall number:** Z-1429-2021
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-05
- **Report date:** 2021-04-21
- **Termination date:** 2023-01-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Maple Grove, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1429-2021

## Citation

> AI Analytics. FDA recall Z-1429-2021. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-1429-2021. Source: US FDA. Licensed CC0.

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