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.
Reported: April 21, 2021 Initiated: March 5, 2021 #Z-1429-2021
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.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 52 devices
- 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
- Location
- Maple Grove, MN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Boston Scientific Corporation. Units affected: 52 devices.
Why was this product recalled? ▼
The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 21, 2021. Severity: Moderate. Recall number: Z-1429-2021.
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