Tag: 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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FDA Proposes Order Forcing Philips to Repair, Replace or Refund All Recalled Ventilators

The FDA is proposing an order be issued that would require Philips Respironics to address recalled devices, including millions of ventilators.

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Philips’ Ventilator Woes Drag on with Yet Another Class I Recall

The U.S. FDA announced a Class I recall—the most serious type of recall—for the Philips Respironics V60 and V60 Plus Ventilator.

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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.

Successful Medical Device Recall Management

Dec 3, 2021

Overseeing medical device recalls can be a cumbersome process. But healthcare technology management professionals can reduce headaches—and streamline the process—with these steps.

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Tag: recall

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

BD Voluntarily Recalls Intraosseous Products

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

FDA Gets Over 21,000 Medical Device Reports, Including 124 Deaths, Linked to Philips Foam Breakdown

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

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FDA Proposes Order Forcing Philips to Repair, Replace or Refund All Recalled Ventilators

Medtronic Recalls Harmony Delivery Catheters Due to Breakage Risk

NotiSphere Awarded Contract With Vizient for Recall Management Solution

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

FDA Can’t Explain Record-Low Medical Device Recalls

Thousands of Ventilators Pulled as Electrical Faults Put UK Patients’ Lives at Risk

Medtronic Recalls 6,000 Drug-Coated Balloons Shipped in Potentially Unsterile Packaging

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Philips’ Ventilator Woes Drag on with Yet Another Class I Recall

Medtronic Recalls TurboHawk Plus Atherectomy System

FDA Orders Philips to Notify Patients of Recall of Certain Breathing Assistance Machines

Man Waiting Months for BiPap Machine to Be Fixed After Recall

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

Philips Provides Update on Sleep Care Product Recall

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

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

BD Voluntarily Recalls Intraosseous Products

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

FDA Gets Over 21,000 Medical Device Reports, Including 124 Deaths, Linked to Philips Foam Breakdown

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

Successful Medical Device Recall Management

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