Agency classClass IOur severity:Severe FDA (Devices)·Z-0392-2016·Announced 2015-12-30

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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Boston Scientific is voluntarily recalling its Chariot" Guiding Sheath. To date, Boston Scientific has received fourteen complaints for shaft separation, four for distal shaft separation. The most severe outcome of this failure is embolism…"

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…
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Interventional Cardiology
Hazard: shaft-separation
embolism
Affected units: 7,985

Distribution

Distributed nationwide across the United States.

The notice also names 46 states specifically:

Same manufacturer · Boston Scientific Corporation

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Same hazard · shaft separation