Z-1383-2021Class II

Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Item Code...

Name: Z-1383-2021 Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Item Code...
Creator: Covidien, LP
Published: 2021-03-04
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-03-04 / Terminated

FDA source

Covidien, LP began a recall of Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Item Code: SIGSDL45CTVT on 2021-03-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1383-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-04
Posted: 2021-04-09
Terminated: 2024-07-12
Recalling firm: Medtronic, Inc.
Product: Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Item Code: SIGSDL45CTVT
Product code: GDW Staple, Implantable
Reason for recall: 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.
FDA 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 in commerce: 5928 units WW: 4212 US 1716 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.
Product codes and lots: Lot Numbers: N0A1038UY N0E0016UY N0F0616UY N0K0934UY N0B0493UY N0F0254UY N0F0817UY N0M0334UY N0C0436UY N0F0518UY N0G0388UY N9K1095UY N0D0731UY N0F0615UY N0J0859UY N9L0797UY UDI: 10884521741843 20884521741840

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1383-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1383-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-21	2021-04-09
Z-1384-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-21	2021-04-09
Z-1385-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-21	2021-04-09

Product code GDW

K191070Class IISignia Small Diameter ReloadsCovidien / cleared 2019-09-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)