Z-0748-2021Class II

Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal...

Name: Z-0748-2021 Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal...
Creator: Covidien Llc
Published: 2020-11-23
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2020-11-23 / Completed / root cause: manufacturing process

FDA source

Covidien Llc began a recall of Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal, gynecological, pediatric and thoracic surgical... on 2020-11-23. FDA classified it as Class II and gives the reason as "May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line preventing adequate hemostasis, or leading to anastomotic leak...". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0748-2021
Classification: Class II
Status: Completed
Initiated: 2020-11-23
Posted: 2020-12-29
Recalling firm: Medtronic, Inc.
Product: Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3L
Product code: GDW Staple, Implantable
Reason for recall: May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line preventing adequate hemostasis, or leading to anastomotic leak, pneumothorax, tissue damage or other delayed secondary complications including infection, peritonitis, and sepsis
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medtronic issued Urgent Medical Device Recall letter by letter delivered via Federal Express and/or certified mail beginning November 23, 2020. The letter 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 above. 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 TA" Auto Suture" Vascular Stapler and Loading Unit with DST Series" Technology listed above, 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 We request that you contact Medtronic if you experienced a quality problem or adverse event. Email Medtronic Post Market Vigilance at: [email protected] 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: 5316 units US; 1209 units OUS
Distribution: Nationwide Foreign: Canada, Albania Armenia Australia Austria Belarus Belgium Bosnia And Herzegovina Cyprus Czech Republic Egypt Estonia France Germany Greece Hungary Iceland Israel Italy Japan Jordan Korea Kuwait Latvia Libyan Arab Jamahiriya Lithuania Malaysia Martinique Morocco Myanmar, Netherlands Norway Pakistan Poland Russian Federation Serbia Singapore Slovakia Spain Sweden Switzerland Taiwan Turkey United Arab Emirates United Kingdom Viet Nam
Product codes and lots: Lot Numbers: P0B1335MY, P0D0170MY, P0D1445M, 0F0377MY, P0B1336MY,P0D1444MY, P0E1211MY, P0F0606MY. UDI: 10884521043152, 20884521043159

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0748-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0747-2021	Class II	Completed	Voluntary: Firm initiated	2021-01-06	2020-12-29
Z-0748-2021	Class II	Completed	Voluntary: Firm initiated	2021-01-06	2020-12-29

Product code GDW

K111825Class IIEndo Gia(tm) Staplers, Dst Series(tm) Gia(tm) Staplers, Dst Series(tm) Ta(tm) StaplersCovidien, Formerly US Surgical A Divison of Tyco H / cleared 2011-10-25

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)