Boston Scientific Recalls Chariot Guiding Sheaths Due to Shaft Separation
Boston Scientific is voluntarily recalling Chariot Guiding Sheaths after receiving complaints about shaft separation, which could lead to embolism of device fragments.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (embolism) and reported complaints of failure, but the source text does not explicitly state that injuries or illnesses have occurred, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is voluntarily recalling its Chariot Guiding Sheaths. The recall involves 7,985 units of the device, which is designed to serve as an introducer sheath for delivering interventional and diagnostic devices into the peripheral vasculature. The affected products were distributed worldwide, including across the United States and in numerous international countries.
The recall was initiated after Boston Scientific received fourteen complaints regarding shaft separation, with four of those complaints specifically citing distal shaft separation. The most severe potential outcome of this failure is the embolism of device fragments. The source text does not report any specific illnesses, injuries, or fatalities associated with these complaints.
Healthcare providers and consumers should check their inventory for the specific material numbers and batch codes listed in the official recall notice. If you have these devices, you should stop using them and contact Boston Scientific for instructions on return or replacement.
The recalled product
- Product
- Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene oxide: Product Description Material Number (UPN) Guiding Sheath 5F, 45 cm, ST, CC H74939277545110 Guiding Sheath 5F, 45 cm, MP, CC H74939277545210 Guiding Sheath 6F, 45 cm, ST, CC H74939277645110 G
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 7,985
Distribution
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