Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB
FDA device recall Z-1465-2024 · posted 2024-04-03 · Open, Classified
Recall details
- Recalling firm
- Covidien, LP
- Reason for recall
- The potential for trocar seal disengagement when using mesh products incorrectly with the device.
- 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.
- Root cause
- Labeling design
- Status
- Open, Classified
- Product code
- GCJ
- Quantity affected
- 124,863 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,
- Date initiated
- 2024-02-28
- Date posted
- 2024-04-03
- Location
- North Haven, CT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ORIGIN BLUNT TIP SURGICAL TROCAR (K924011) | Origin Medsystems, Inc. | 1993-07-09 |