Abbott to Recall Coronary Dilatation Catheters Due to Failure of Balloon Deflation

 Abbott to Recall Coronary Dilatation Catheters Due to Failure of Balloon Deflation

Abbott to Recall Coronary Dilatation Catheters Due to Failure of Balloon Deflation

Shots:

  • Abbott has recalled 13,891 NC Trek RX and NC Traveler RX coronary dilatation catheter with 4.0mm, 4.5mm and 5.0mm balloon diameters, distributed b/w Aug’2019 to Jan’2020 in the US. The FDA has labeled it as Class I recall
  • The recall is due to the inability of balloons to deflate as intended. The problem stems from weaker material close to the balloon bond that resulted from excessive exposure to heat during manufacturing
  • The company has received 13 complaints including 1 death. The coronary dilatation catheters are used to open clogged blood vessels to improve the blood flow of heart

Click here ­to­ read full press release/ article | Ref: FDA | Image: Marlins Medico

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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