Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB

This recall is currently active, issued April 3, 2024.

Recall Initiated: February 28, 2024
Posted: April 3, 2024
Recall Number: Z-1465-2024
Quantity: 124,863 units
Firm Location: North Haven, CT
Official Source: View on FDA website ↗

Reason for Recall

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

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 / Code Info

Product Number/CFN: OMS-T10SB; UDI/DI: 20884521081083 and 10884521081086; Lot Serial Number: P0B1097Y, P0L1408, P0L1408, P0L1442, P0L1442, P0M1720, P0M1721, P0M1931, P1A1469, P1A1469, P1A1470, P1A1485, P1A1486, P1A1486, P1B1294, P1B1294, P1B1449, P1C0441, P1C1565, P1C1565, P1C1566, P1C1568, P1C1674, P1C1674, P1C1675, P1C1676, P1C1676, P1C1786, P1C1920, P1D0366, P1D1379, P1D1379, P1D1380, P1D1380, P1D1509, P1D1509, P1E1551, P1F1389, P1F1482, P1F1482, P1F1521, P1G0143, P1G0143, P1K0808, P1K0808, P1K1036, P1K1099, P1K1099, P1K1320, P1L0482, P1L0482, P1L0486, P1L0486, P1L0679, P1L0679, P1L0680, P1L0680, P1L0885, P1L0885, P1L1108, P1L1109, P1L1109, P1M0032, P1M0032, P1M0033, P1M0033, P2A0611, P2A0611, P2A0612, P2A0612, P2A0613, P2A0613, P2A0614, P2A0615, P2A0615, P2B0280, P2B0280, P2C0455, P2C0456, P2C0457, P2C0745, P2C0745, P2D0324, P2D0325, P2D0325, P2D0326, P2D0327, P2D0352, P2D0352, P2D0353, P2D0353, P2E0013, P2E0013, P2E0014, P2E0014, P2E0076, P2E0077, P2E0077, P2E0078, P2E0352, P2E0447, P2E0448, P2E0449, P2E0449, P2F0136, P2F0136, P2F0137, P2F0137, P2F0138, P2F0139, P2F0139, P2F0384, P2F0384, P2F0455, P2F0455, P2F0456, P2F0456, P2F0457, P2F0457, P2G0324, P2G0324, P2H0044, P2H0273, P2H0307, P2H0414, P2J0025, P2J0083, P2J0286, P2J0455, P2K0149, P2K0440, P2L0090, P2L0091, P2L0091, P2M0031, P3A0237, P3A0238, P3A0239, P3A0240, P3A0240, P3B0308, P3B0443, P3B0444, P3B0444, P3D0349, P3D0350, P3D0350, P3E0080, P3E0080, P3E0371, P3E0458, P3E0458, P3F0043, P3F0043, P3F0044, P3H0831, P3H1177, P3H1177, P3J0865, P3J0865, P3J0944, P3J0944, P3J0945, P3J0945, P3J0946, P3J1063, P3J1064, P3J1131, P3L0678, P3L0679, P3L0820, P3L0821;

Root Cause

Labeling design

Action Taken

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.