MAMBA Flex recallZ-1429-2021 · Boston Scientific Corporation · initiated Mar 5, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.
FDA root cause category: Labeling False and Misleading
What the company is doing
A Recall notification letter titled, "Medical Device Removal - Immediate Action Required" was sent to the OUS consignees on 03/05/2021 and the U.S. consignees on 03/08/2021 via overnight mail delivery. Customers outside of the US were either contacted via letter delivery or email. The recalling firm requested if the consignees identify any product from the listed batch within their inventory, to please segregate the product immediately and return it to Boston Scientific in accordance with the enclosed instructions. The consignees will receive replacement product for all removed product returned to Boston Scientific. Distributors are also informed in the letter that the removal depth is to the hospital level and the removal notification should be forwarded to their customers. The field removal letter provides customers with the product segregation and return instructions and accounts are asked to complete a Reply Verification Tracking Form indicating they have received the field removal and followed the included instructions.
Recall details
- Recall number
- Z-1429-2021
- Status
- Terminated
- Initiated by the company
- Mar 5, 2021
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 52 devices
- Product code
- DQY
- FDA submissions
- K190401
- 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
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.
Code information (models, lots, serial numbers)
UPN: H7493928713540 US (Green); Batches: 26578463 and 26578470; GTIN: 8714729940289; and Expiration Date: 4-Jan-23
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MAMBA™ Flex H7493928713540Boston Scientific Corporation · CATHETER, PERCUTANEOUS1 recall7 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 87539).
- Z-1430-2021 · TerminatedMAMBA 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 labe…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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