Recall record at a glance
| Official record | Z-1430-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Boston Scientific Corporation |
| Report date | Apr 21, 2021 |
| Recall initiation date | Mar 5, 2021 |
| Quantity | 63 devices |
| Location | Maple Grove, MN, United States |
Official product description
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.
Why the product was recalled
The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.
Distribution information
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
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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