Public recall detail

Auto Suture Blunt Tip and Structural Balloon Trocar

2024-03-13

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Recall Safety notice
Quick summary

Quick summary: Auto Suture Blunt Tip and Structural Balloon Trocar. Date: 2024-03-13.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Auto Suture Blunt Tip and Structural Balloon Trocar. Date: 2024-03-13.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandCOVIDIEN LLC
ProductAuto Suture Blunt Tip and Structural Balloon Trocar
IssueMedical devices - Performance
Recall classType II
IdentificationRA-75231

Affected products

ProductAuto Suture Blunt Tip Trocar
LotMore than 10 numbers, contact manufacturer.
ModelOMS-T10BTS OMS-T10BTNL OMS-T10BTSNL OMS-T12BT OMS-T10BT OMS-T12BTNL
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionAuto Suture Blunt Tip Trocar
ProductAuto Suture Structural Balloon Trocar
LotMore than 10 numbers, contact manufacturer.
ModelOMS-T10SB
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionAuto Suture Structural Balloon Trocar

Issue

Medtronic received reports of events related to Covidien Auto Suture™ Structural Balloon Trocar and Auto Suture™ Blunt Tip Trocar reporting trocar seal disengagement when using the trocar with certain mesh products. This issue can occur when the trocar is used to deploy the mesh not in accordance with the mesh instructions for use (IFU). Not following the IFU for the mesh including use of incompatible trocar size, excess force, and not hydrating the mesh and/or folding of the mesh could result in a seal disengaging into the cavity. Recall Start Date: March 4, 2024

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Gastroenterology and urology Health products - Medical devices - General and plastic surgery
CompaniesCovidien Llc 15 Hampshire Street, Mansfield, Massachusetts, United States, 02048
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-75231
Background{}
CompaniesCovidien Llc 15 Hampshire Street, Mansfield, Massachusetts, United States, 02048
AudiencesHealthcare
Source updated2024-03-13

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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