Tag: class 1 recall

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Medtronic, Baxter Face FDA Class I Labels for Separate Recalls of Heart Pumps, Ventilators

Amid continued recall concerns, devices from Medtronic and Baxter were recently assigned the most serious recall type be the FDA.

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Medtronic Recalls Harmony Delivery Catheters Due to Breakage Risk

Medtronic is recalling its Harmony Delivery Catheter due to a risk where the bond holding the capsule at the end of the catheter may break.

Philips Piles on Another Trio of Class I Recalls for Beleaguered Ventilator Portfolio
FDA Upgrades Baxter Infusion Pump Safety Issue to Class I Recall
Medtronic’s HawkOne Recall Labeled Class I, Adding to Medtech’s Product Safety Problems
Medtronic’s Covidien Recall of Some Puritan Bennett Ventilators Is Class I
FDA Provides Update on Recall of Certain Philips Respironics Breathing Assistance Machines
Zimmer Biomet Software Error Prompts Class I Recall of Rosa One Robotic Neurosurgery Platform

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St. Jude Agrees to Pay $27M for Allegedly Selling Defective Heart Devices

The government alleges that St. Jude failed to disclose serious adverse health events in connection with the premature depletion of the battery in certain models of its implantable defibrillators.

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Medtronic, Baxter Face FDA Class I Labels for Separate Recalls of Heart Pumps, Ventilators

Amid continued recall concerns, devices from Medtronic and Baxter were recently assigned the most serious recall type be the FDA.

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Tag: class 1 recall

All

Medtronic, Baxter Face FDA Class I Labels for Separate Recalls of Heart Pumps, Ventilators

Draeger Breathing Filter Gets Class I Recall

Dräger’s Breathing System Filter Recall Gets Class I Label from FDA After Ventilation Obstruction

Medtronic’s HVAD Pump Implant Kit Gets Class I Recall for Weld Defect

Abbott Recalls Imaging Catheter for Potential Loose Catheter Marker Band

Avanos Medical’s Enteral Access System Gets FDA Class I Recall

Medtronic’s Covidien Gets Class I Recall for Puritan Bennett 980 Ventilators

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Medtronic Recalls Harmony Delivery Catheters Due to Breakage Risk

Philips Piles on Another Trio of Class I Recalls for Beleaguered Ventilator Portfolio

FDA Upgrades Baxter Infusion Pump Safety Issue to Class I Recall

Medtronic’s HawkOne Recall Labeled Class I, Adding to Medtech’s Product Safety Problems

Medtronic’s Covidien Recall of Some Puritan Bennett Ventilators Is Class I

FDA Provides Update on Recall of Certain Philips Respironics Breathing Assistance Machines

Zimmer Biomet Software Error Prompts Class I Recall of Rosa One Robotic Neurosurgery Platform

All

St. Jude Agrees to Pay $27M for Allegedly Selling Defective Heart Devices

Boston Scientific Recalls Over 30,000 Stent Systems Due to Migration Risk

FDA Announces Class 1 Recall of Alaris Infusion Pump Module 8100 Bezel

Medtronic’s HeartWare Receives Another Class I Recall After More Patient Deaths

Medtronic Announces Voluntary Field Corrective Action for Ventilator Series

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Medtronic, Baxter Face FDA Class I Labels for Separate Recalls of Heart Pumps, Ventilators

Draeger Breathing Filter Gets Class I Recall

Dräger’s Breathing System Filter Recall Gets Class I Label from FDA After Ventilation Obstruction

Medtronic’s HVAD Pump Implant Kit Gets Class I Recall for Weld Defect

Abbott Recalls Imaging Catheter for Potential Loose Catheter Marker Band

Avanos Medical’s Enteral Access System Gets FDA Class I Recall

Medtronic’s Covidien Gets Class I Recall for Puritan Bennett 980 Ventilators

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