Boston Scientific MAMBA Flex 135 Microcatheter Recall: Incorrect Labeling and Packaging
Boston Scientific recalls certain batches of MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging. Affected units have specific batch numbers and expiration dates. Consumers should check their product details to determine if they are affected.
Lower-risk recall
The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.
Contact the company
What happened, in plain English
Boston Scientific is recalling specific batches of MAMBA Flex 135 Microcatheters because they were incorrectly labeled and packaged. This issue does not pose a safety risk but requires correction to ensure proper use and documentation. Read more at govinfonow.com/recall/63139-boston-scientific-mamba-flex-135-microcatheter-recall-incorrect-labeling-and.
Source Summary by GovInfoNow · govinfonow.com/recall/63139-boston-scientific-mamba-flex-135-microcatheter-recall-incorrect-labeling-and · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1429-2021
Cite this page
“Boston Scientific MAMBA Flex 135 Microcatheter Recall: Incorrect Labeling and Packaging.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63139-boston-scientific-mamba-flex-135-microcatheter-recall-incorrect-labeling-and. Based on FDA recall #Z-1429-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1429-2021%22&limit=1).
Why it’s dangerous
The microcatheters were packaged with incorrect labels and a missing closure strip, which could lead to confusion during medical procedures. However, this does not cause immediate harm or injury.
Who’s affected
Healthcare professionals who use these microcatheters in medical procedures may be affected. Patients using these devices are not directly impacted by the labeling issue.
How to tell if you have this one
Check for batch numbers 26578463 or 26578470 on the carton. The product was sold with an expiration date of January 4, 2023, and is labeled with a green color code.
- Brand
Boston Scientific- Product
MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- 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
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1429-2021 | 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.; UPN: H7493928713540 US (Green); Batches: 26578463 and 26578470; GTIN: 8714729940289; and Expiration Date: 4-Jan-23 | 52 devices |
| Z-1430-2021 | 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.; 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 | 63 devices |
What to do — step by step
Check Product Details
Identify the batch number on the carton to determine if your microcatheter is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 25 states.
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, Colorado, Florida, Georgia, Illinois, Iowa, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, Missouri, Nevada, New York, North Carolina, North Dakota, Ohio, Oklahoma, Puerto Rico, South Carolina, Tennessee, Virginia, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1429-2021 (March 5, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1429-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.