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Safety Reports: Medical Devices

Updated: October 18, 2024 9:01 PM

Recent Reports

Medtronic MiniMed series insulin pumps - recalled due to Defect, USA

3 days ago •source fda.gov • details

Recall notice

Medtronic plc voluntarily issued a field action starting on July 31, 2024, notifying global customers of its MiniMed™ 600 series or 700 series insulin pumps to follow their pump’s built-in alerts and alarms for battery status and to contact Medtronic if they observe changes in the battery… See more

#recall #medicaldevices #us

Medtronic MiniMed series insulin pumps - recalled due to Defect photo #1

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Philips Respironics Trilogy Evo Ventilators- recalled due to inaccurate flow measurements, USA

2 weeks ago •source fda.gov • details

Recall notice

Philips Respironics issued a voluntary recall for Trilogy Evo Ventilators regarding the use of in-line nebulizers. The products have been distributed nationwide.

Potential hazards to patients from these conditions may include respiratory discomfort; lung injury from too much air in the lungs or change in pressure (volutrauma/barotrauma);… See more

#recall #medicaldevices #us

Philips Respironics Trilogy Evo Ventilators- recalled due to inaccurate flow measurements photo #1

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Pediatric and Adult Tracheostomy products - recalled due to manufacturing defect, USA

1 month ago •source fda.gov • details

Recall notice

Smiths Medical issued an Urgent Medical Device Notification on May 29, 2024, to notify affected customers of a potential issue with certain Bivona® Tracheostomy Tubes in the United States.

The customer notification sent on May 29, 2024, indicated that if the flange on the item is torn… See more

#medicaldevices #us

Pediatric and Adult Tracheostomy products - recalled due to manufacturing defect photo #1

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Tandem iOS Mobile App - recalled due to Insulin Pump Battery Issue, USA

2 months ago •source fda.gov • details

Recall notice

Tandem Diabetes Care, Inc. (Nasdaq: TNDM) today provided an update on the March 2024 recall of its Apple iOS t:connect mobile app in the United States relating to an issue that can cause rapid depletion of a user’s t:slim X2 insulin pump battery. This battery depletion can… See more

#medicaldevices #us

Tandem iOS Mobile App - recalled due to Insulin Pump Battery Issue photo #1

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Breas Vivo 45 LS Ventilator - recalled due to formaldehyde exposure, USA

2 months ago •source fda.gov • details

Recall notice

Breas Medical initiated a U.S. nationwide correction of 8,186 Vivo 45 LS ventilator devices. Internal testing of the ventilator identified the potential for short term elevated levels of formaldehyde exposure to users under specific conditions.

Short term formaldehyde emissions may lead to adverse pulmonary or neurological effects… See more

#recall #medicaldevices #us

Breas Vivo 45 LS Ventilator - recalled due to formaldehyde exposure photo #1

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Abbott FreeStyle Libre® 3 sensors - recalled due to Sensors incorrect readings, USA

2 months ago •source fda.gov • details

Recall notice

Abbott has initiated a voluntary medical device correction for a small number of FreeStyle Libre® 3 sensors due to sensors may provide incorrect high glucose readings. The product was distributed in the United States during the first half of May 2024.

The FreeStyle Libre 3 system includes… See more

#medicaldevices #recall #us

Abbott FreeStyle Libre® 3 sensors - recalled due to Sensors incorrect readings photo #1

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Volara System Single-Patient Use Circuit and Blue Ventilator Adapter recalled for Handset Plug Issue, USA

3 months ago •source fda.gov • details

Recall notice

Baxter International Inc. issued an Urgent Medical Device Recall for certain lots of the Volara system single-patient use circuit and blue ventilator adapter assembly. The recall is due to reports of the handset plug disconnecting from the nebulizer port on the blue ventilator adapter. The impacted accessories… See more

#recall #medicaldevices #us

Volara System Single-Patient Use Circuit and Blue Ventilator Adapter recalled for Handset Plug Issue photo #1

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Volara system single-patient use circuit and blue ventilator adapter assembly - recalled due to quality issues, USA

3 months ago •source fda.gov • details

Recall notice

Baxter International Inc. announced today it has issued an Urgent Medical Device Recall for certain lots of the Volara system single-patient use circuit and blue ventilator adapter assembly. The recall is due to reports of the handset plug disconnecting from the nebulizer port on the blue ventilator… See more

#medicaldevices #us

Volara system single-patient use circuit and blue ventilator adapter assembly - recalled due to quality issues photo #1

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Baxter Life2000 Ventilator - recalled due to battery charger dongle damage, USA

3 months ago •source fda.gov • details

Recall notice

Baxter International Inc. announced today it has issued an Urgent Medical Device Recall for Life2000 ventilators with an attached battery charger dongle. The recall is due to reports that the devices are not properly charging when there is damage to the battery charger dongle. The impacted ventilators… See more

#recall #medicaldevices #us

Baxter Life2000 Ventilator - recalled due to battery charger dongle damage photo #1

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Medline SubG Endotracheal Tubes with Subglottic Suction - recalled due to potential malfunction, USA

4 months ago •source fda.gov • details

Recall notice

Medline Industries, LP initiated a nationwide recall of 6 SubG Endotracheal Tubes with Subglottic Suction and 10 kits that contain these devices. The inflation tube and other device components have become detached and/or torn from the main tube, resulting in moisture buildup, loss of pressure, or inability… See more

#recall #medicaldevices #us

Medline SubG Endotracheal Tubes with Subglottic Suction - recalled due to potential malfunction photo #1

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Safety Reports: Medical Devices

Medtronic MiniMed series insulin pumps - recalled due to Defect, USA

Philips Respironics Trilogy Evo Ventilators- recalled due to inaccurate flow measurements, USA

Pediatric and Adult Tracheostomy products - recalled due to manufacturing defect, USA

Tandem iOS Mobile App - recalled due to Insulin Pump Battery Issue, USA

Breas Vivo 45 LS Ventilator - recalled due to formaldehyde exposure, USA

Abbott FreeStyle Libre® 3 sensors - recalled due to Sensors incorrect readings, USA

Volara System Single-Patient Use Circuit and Blue Ventilator Adapter recalled for Handset Plug Issue, USA

Volara system single-patient use circuit and blue ventilator adapter assembly - recalled due to quality issues, USA

Baxter Life2000 Ventilator - recalled due to battery charger dongle damage, USA

Medline SubG Endotracheal Tubes with Subglottic Suction - recalled due to potential malfunction, USA

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