—#186250

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.

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K190401
Affected lot / code info: UPN: H7493928713540 US (Green); Batches: 26578463 and 26578470; GTIN: 8714729940289; and Expiration Date: 4-Jan-23

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.

Root cause (FDA determination)

Labeling False and Misleading

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 1 Scimed Pl, Maple Grove, Minnesota 55311-1565

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2021-03-05
Terminated: 2023-01-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #186250. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.