Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall MAMBA Flex 135 Microcatheter

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall MAMBA Flex 135 Microcathetersee related information
Date Initiated by FirmMarch 05, 2021
Create DateApril 15, 2021
Recall Status1 Terminated 3 on January 05, 2023
Recall NumberZ-1429-2021
Recall Event ID 87539
510(K)NumberK190401 
Product Classification Catheter, percutaneous - Product Code DQY
ProductMAMBA 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 UPN: H7493928713540 US (Green); Batches: 26578463 and 26578470; GTIN: 8714729940289; and Expiration Date: 4-Jan-23
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information ContactRebecca KinKead Rubio
763-494-1133
Manufacturer 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.
FDA Determined
Cause 2		Labeling False and Misleading
ActionA 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 Commerce52 devices
DistributionDistributed 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DQY
-
-