Abbott, ResMed, Teleflex announce 3 high-risk device recalls in one day

Maia Anderson - Print  | 

Devicemakers Abbott, ResMed and Teleflex all announced high-risk medical device recalls Feb. 19. 

All of the recalls were classified by the FDA as Class I, the most serious type of recall, meaning use of the device could cause serious harm or death. 

Abbott is recalling 13,891 of its coronary dilation catheters, which are used to open clogged blood vessels, often in heart attack patients. 

Abbott said the catheters may not deflate as they're supposed to, which could cause serious adverse effects such as reduced blood flow to the heart, a clotted artery, heart attack or death. 

Abbott has received 13 complaints, and one death has been reported. 

Teleflex is recalling its Comfort Flo humidification system, which is used to provide breathing gases to patients. 

Teleflex said there's a risk for water to flood the device's column and enter the nose and lungs of patients, which can cause low oxygen in the blood or the need for further treatment to prevent long-term injury. 

Teleflex has received 102 complaints and eight injuries. No deaths have been reported. 

ResMed is recalling its Stellar ventilators, which are used to provide breathing support to patients. 

Resmed said technical glitches may stop the alarm from sounding and fail to alert providers of patient issues. There has been one reported death. 

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