Z-1384-2021Class II

Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm - Short Item Code...

Name: Z-1384-2021 Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm - Short 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 Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm - Short Item Code: SIGSDS30CTV 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-1384-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-04
Posted: 2021-04-09
Terminated: 2024-07-12
Recalling firm: Medtronic, Inc.
Product: Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm - Short Item Code: SIGSDS30CTV
Product code: CDW Diacetyl-Monoxime, Urea Nitrogen
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: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1384-2021
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 CDW

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)