FDA Medical Device Recalls (openFDA)
Covidien, LP: Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm - Short Item Code: SIGSDS30CTV
- Recall number
- Z-1384-2021
- Recalling firm
- Covidien, LP
- Product
- Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm - Short Item Code: SIGSDS30CTV
- Status
- Terminated
- Initiated
- 2021-03-04
- Posted
- not on file
- Terminated
- 2024-07-12
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 11391 units WW: 5982 US 5409 OUS
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Austria, Belgium, Chile, China, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom.
- Lot, serial or model codes
- Lot Numbers: N0A0191UY N0D0392UY N0F0406UY N0L0708UY N0B0657UY N0E0133UY N0G0907UY N9K0376UY N0C0349UY N0E0956UY N0J0746UY N9K1093UY N0C0492UY N0E1026UY N0K0248UY N9L0796UY N0C1008UY N0F0202UY N0K0803UY N9M0418UY N0D0283UY N0F0221UY N0L0307UY N9M0651UY UDI: 10884521741881 20884521741888
- 510(k) numbers
- ["K191070"]
- PMA numbers
- not on file
- Product code
- CDW
- Firm FEI
- 1219930
- Firm city
- North Haven
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28