Recalls for Covidien

FDA Classifies Previous Covidien Field Action For Its Trellis-6 and Trellis-8 Peripheral Infusion Systems as a Class 1 Recall
02/13/2015 Food Recall

Medtronic announced today that a previously communicated global voluntary recall to address an issue with certain lots of its Trellis-6 and Trellis-8 peripheral infusion systems has now been classified as a Class 1 Recall by the U.S. Food and Drug Administration. Customers were previously notified by Covidien of the recall on December 15, 2014.

  • Company:
    Covidien
  • Problem
    Manufacturing error where the proximal and distal balloon inflation ports were labeled incorrectly, resulting in the potential for incorrect sequence of balloon deflation.
Trellis 6 and Trellis 8 Peripheral Infusion Systems by Covidien: Class I Recall - Balloon Inflation Ports Mislabeled
02/11/2015 Medical Recall

The physician using the device may deflate the balloons in the incorrect order. If this happens, there is a potential for blood clots to dislodge and move into the lungs.

  • Company:
    Covidien
Nellcor Puritan Bennett 980 Ventilator System by Covidien: Class I Recall - Component Failure May Cause Burning Odor
12/31/2014 Medical Recall

Problems in the manufacturing process may lead to unexpected need to stop the ventilator and transfer the patient to another ventilator.

  • Company:
    Covidien
Nellcor Puritan Bennett, 980 Ventilator System: Class I Recall - Software Issue May Stop Ventilator
11/07/2014 Medical Recall

Ventilator may stop working after the air and oxygen gas supply lines are disconnected and then reconnected. This can lead to serious health problems or death.

  • Company:
    Covidien
Covidien Initiates Voluntary Field Safety Alert for Medi-Trace™ Cadence and Kendall™ Multi-function Defibrillation Electrodes
10/12/2014 Food Recall

Covidien today announced that it has notified customers of a voluntary Field Safety Alert for certain Medi-Trace Cadence and Kendall Multi-function Defibrillation Electrodes due to a connector compatibility issue with Philips FR3 and FRx Defibrillators.

  • Company:
    Covidien
  • Problem
    Connector Compatibility Issue With Philips Fr3 And F Rx Defibrillators
HydroFinity Hydrophilic Guidewires by NDC/Covidien: Recall - Outer Jacket Damage
06/20/2014 Medical Recall

Damage to the jacket can result in embolization of polymer, potentially leading to vessel occlusion or damage.

  • Company:
    Covidien
Covidien Implements Voluntary Recall of its Pipeline™ Embolization Device and Alligator™ Retrieval Device
04/11/2014 Food Recall

Covidien plc today announced that it has notified customers of a voluntary recall to address an issue with certain lots of its Pipeline™ Embolization Device and Alligator™ Retrieval Device where the polytetrafluoroethylene (PTFE) coating applied to the delivery wire could delaminate and detach from the devices.

  • Company:
    Covidien
  • Problem
    Polytetrafluoroethylene (PTFE) coating applied to the delivery wire could delaminate and detach from the devices
Puritan Bennett 840 Series Ventilator by Covidien - Class I Recall - Software Problem
01/10/2014 Medical Recall

Ventilator may stop functioning, triggering the safety alarm and causing the patient to suddenly be required to breathe on his or her own.

  • Company:
    Covidien
Covidien Monoject Prefill Flush Syringes: Recall - Not Subjected To AutoClave Sterilization Process Or Mismatched Syringe Tip Cap, Syringe Label, Filled Volume And Wrapper
08/20/2013 Medical Recall

Health risk of life-threatening infection to the blood stream or patency of device may not be maintained and clotting may occur.

  • Company:
    Covidien
Covidien Initiates a Voluntary Recall of Certain Lots of Monoject Prefill Flush Syringes Sold in the United States and Bermuda
08/19/2013 Food Recall

August 19, 2013 - Mansfield, MA – Covidien today announced that it has initiated a voluntary recall of certain lots of Monoject prefill flush syringes. Reasons for Recall: This recall is being conducted due to the risk that a number of the syringes were filled with water but not subjected to the autoclave sterilization process.

  • Company:
    Covidien
  • Problem
    May contain non-sterile water and have mismatched syringe tip cap, syringe label, filled volumn and wrapper.