Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Item Code: SIGSDL45CTVT Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Item Code: SIGSDL45CTVT
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Lot Numbers: N0A1038UY N0E0016UY N0F0616UY N0K0934UY N0B0493UY N0F0254UY N0F0817UY N0M0334UY N0C0436UY N0F0518UY N0G0388UY N9K1095UY N0D0731UY N0F0615UY N0J0859UY N9L0797UY UDI: 10884521741843 20884521741840
A medical device manufacturer is recalling Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Item Co due to Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the empty single-use reload is fired a second time, the stapler may cut tissue but no staples will deploy from the empty reload, potentially resulting in a failed anastomosis, bleeding, tissue trauma, and the potential need to convert to an open procedure.
Recommended Action
Per FDA guidance
Covidien/Medtronic issued Urgent Medical Device Recall via Federal Express and/or certified mail beginning March 4, 2021, states reason for recall, health risk and action to take: 1. Please immediately quarantine and discontinue use of affected item codes with associated lot numbers listed on Attachment A. 2. Please return affected product as indicated below. All unused products from the affected item codes and associated lot numbers must be returned. 3. If you have distributed the Covidien Signia" small diameter curved tip intelligent reload listed on Attachment A, please promptly forward the information from this letter to those recipients. 4. Complete the Recalled Product Return Form even if you do not have inventory. If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.
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