Z-1457-2024Class II

Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT

Name: Z-1457-2024 Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Creator: Covidien, LP
Published: 2024-02-14
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2024-02-14 / Open, Classified

FDA source

Covidien, LP began a recall of Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT on 2024-02-14. FDA classified it as Class II and gives the reason as "Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1457-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-14
Posted: 2024-04-01
Recalling firm: Medtronic, Inc.
Product: Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Product code: GDW Staple, Implantable
Reason for recall: Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is related to components in impacted reloads that are not fully secure, which leads to uncontrolled articulation. The issue can occur using either the Endo GIA" Ultra Universal Stapler or Signia" Stapling System.
FDA root cause: Under Investigation by firm
Action: On February 14, 2024, the firm notified domestic customers and notified international customers starting February 19, 2024 of the issue via URGENT: MEDICAL DEVICE RECALL letters. Actions to be taken by the customer: 1. Identify and quarantine all unused impacted product listed above. 2. See Attachment A for guidance on identifying affected lots. 3. Return all quarantined devices to Medtronic. Please contact [email protected] for the Return Goods Authorization (RGA). 4. Credit for the returned affected devices will be issued based on the RGA number. 5. If purchased from a distributor, contact your distributor directly to arrange for the return of the devices back to your distributor. 6. Please complete and return the enclosed Customer Confirmation Form to [email protected] even if you do not have unused inventory. 7. Pass on this notice to all those who need to be aware within your organization or to any organization where the listed affected lots may have been transferred or distributed. Adverse events or quality problems experienced with this product should be reported to the FDA and Medtronic: Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm, or call FDA at 1-800-FDA-1088 (1-800-332-1088) and Medtronic Technical Services at 800-255-6774, option 2 to provide information regarding those events. We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please contact your Medtronic Field Representative or Customer Service at 800-962-9888 Option 2.
Quantity in commerce: 30 Units
Distribution: Worldwide distribution - US Nationwide and the countries of France, Hong Kong, Israel and Japan.
Product codes and lots: Model Number: SIGSDS30CTVT; UDI/DI: 10884521741881; Lot number: N3L1909UY;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1457-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1457-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-04-01
Z-1458-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-04-01

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