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Auto Suture recallZ-1471-2024 · Covidien, LP · initiated Feb 28, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Covidien, LP or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Labeling design

What the company is doing

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 [email protected]. 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.

Recall details

Recall number
Z-1471-2024
Status
Open, Classified
Initiated by the company
Feb 28, 2024
Posted by the FDA
Apr 3, 2024
Recalling firm
Covidien, LP
Quantity
44,777 units
Product code
GCJ
FDA submissions
K924011
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.;

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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;

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

6 devices cleared under K924011 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 94131).

Sources and updates

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