Boston Scientific Corp Boston Scientific brand LeVeen Needle Electrode, 5.0/13/15; Model number M001262160, Ref 26-216. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Boston Scientific brand LeVeen Needle Electrode, 5.0/13/15; Model number M001262160, Ref 26-216.
Brand
Boston Scientific Corp
Lot Codes / Batch Numbers
Lots 31804, 92702, 6538336, 6538341, 6556258, 6556462, 6556464, 6556634, 6826039, 7002067, 7021736, 7091482, 7108067, 7257089, 7356251, 7422492, 7457364, 7664972, 7667650, 21403R, 21703R and 92702R.
Products Sold
Lots 31804, 92702, 6538336, 6538341, 6556258, 6556462, 6556464, 6556634, 6826039, 7002067, 7021736, 7091482, 7108067, 7257089, 7356251, 7422492, 7457364, 7664972, 7667650, 21403R, 21703R and 92702R.
Boston Scientific Corp is recalling Boston Scientific brand LeVeen Needle Electrode, 5.0/13/15; Model number M001262160, Ref 26-216. due to Firm has received complaints of extended ablation times, lack of roll-off and patient burns.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Firm has received complaints of extended ablation times, lack of roll-off and patient burns.
Recommended Action
Per FDA guidance
Distributors and user accounts were notified via medical device correction letter dated 7/29/05.
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