Covidien, LP: Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL

Recall number

Z-1471-2024

Recalling firm

Covidien, LP

Product

Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL

Status

Open, Classified

Initiated

2024-02-28

Posted

2024-04-03

Terminated

not on file

Reason

The potential for trocar seal disengagement when using mesh products incorrectly with the device.

Root cause

Labeling design

Action

On February 28, 2024, the firm notified customers of the issue via URGENT: MEDICAL DEVICE RECALL letters. Actions to be taken by the customer: 1. Inform all surgeons and clinicians who handle the preparation and/ or placement of a Mesh Device that utilize the balloon and blunt tip trocar devices. 2. Prior to using any Mesh device in conjunction with the following Trocars: Covidien Auto Suture" Structural Balloon Trocar and Auto Suture" Blunt Tip Trocar, please carefully review and adhere to the mesh manufacturer s Instructions for Use (IFU) on proper insertion techniques. 3. Please complete and return the customer confirmation form enclosed with this letter acknowledging receipt of this information via email to rs.gmbmitgfca@medtronic.com. 4. Please transfer this notice to other organizations on which this action has an impact and maintain a copy of this notice in your records. 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 Vascular Customer Service at 800-716-6700. 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 Representative.

Quantity

44,777 units

Distribution

Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Aruba, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Gibraltar, Greece, Guadeloupe, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Republic Of, Luxembourg, Macao, Malaysia, Malta, Martinique, Mayotte, Mexico, Netherlands, New Caledonia, New Zealand, Nigeria, Northern Ireland, Norway, Oman, Poland, Portugal, Puerto Rico, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Turkey, United Arab Emirates, United Kingdom, United States, Uzbekistan, Viet Nam, Virgin Islands, U.S.;

Lot, serial or model codes

Product Number/CFN: OMS-T12BTNL; UDI/DI: 20884521552446, 10884521552449; Lot Serial Number: P0L1444, P0L1444, P0M1932, P0M1932, P1A1491, P1A1491, P1B0649, P1B0649, P1B1560, P1B1560, P1D0399, P1D0399, P1G0142, P1G0142, P1G1132, P1G1132, P1G1365, P1J1046, P1J1179, P1J1179, P1J1213, P1J1213, P1L0002, P1M0637, P1M0637, P1M0838, P1M0838, P2A0608, P2A0608, P2B0747, P2B0747, P2B0981, P2B0982, P2B0982, P2C0229, P2C0229, P2C0690, P2C0710, P2C0710, P2F0161, P2G0536, P2G0536, P2G0537, P2G0537, P2H0423, P2J0274, P2J0274, P2J0283, P2J0283, P2K0193, P2K0193, P2K0567, P2M0165, P2M0165, P2M0276, P2M0276, P3A0094, P3B0040, P3B0041, P3B0520, P3B0520, P3D0250, P3D0250, P3E0457, P3F0078, P3F0573, P3G0330, P3G0330, P3H1178, P3H1261, P3J1164;

510(k) numbers

["K924011"]

PMA numbers

not on file

Product code

GCJ

Firm FEI

1219930

Firm city

North Haven

Firm state

CT

Firm country

not on file

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

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