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:Abbott
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