Boston Scientific Scimed WALLSTENT Endoprostheses with UNISTEP Plus Delivery System. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
WALLSTENT Endoprostheses with UNISTEP Plus Delivery System.
Brand
Boston Scientific Scimed
Lot Codes / Batch Numbers
6541400, 6497027, 6256357, 6153225, 6091290, 6070085, 6013424, 5943551, 5903039, 5817491, 5796751, 5726023
Products Sold
6541400, 6497027, 6256357, 6153225, 6091290, 6070085, 6013424, 5943551, 5903039, 5817491, 5796751, 5726023
Boston Scientific Scimed is recalling WALLSTENT Endoprostheses with UNISTEP Plus Delivery System. due to Specific lots of the WALLSTENT Endoprosthesis with UNISTEP Plus Delivery System were packaged without one of the three required directions for use.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Specific lots of the WALLSTENT Endoprosthesis with UNISTEP Plus Delivery System were packaged without one of the three required directions for use.
Recommended Action
Per FDA guidance
Boston Scientific is notifying sales representatives and customers of recall along with instructions regarding the return of potentially affected product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026