Z-1429-2021Class II

MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is...

Name: Z-1429-2021 MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is...
Creator: Boston Scientific Corporation
Published: 2021-03-05
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2021-03-05 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific Corporation began a recall of 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... on 2021-03-05. FDA classified it as Class II and gives the reason as "The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1429-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-05
Posted: 2021-04-15
Terminated: 2023-01-05
Recalling firm: Boston Scientific Corporation
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.
Product code: DQY Catheter, Percutaneous
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: 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.
Quantity in commerce: 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
Product codes and lots: UPN: H7493928713540 US (Green); Batches: 26578463 and 26578470; GTIN: 8714729940289; and Expiration Date: 4-Jan-23

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1429-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1429-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-21	2021-04-15
Z-1430-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-21	2021-04-15

Product code DQY

K190401Class IIMAMBA and MAMBA Flex MicrocathetersBoston Scientific Corporation / cleared 2019-03-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)