Boston Scientific Recalls Mislabeled JETSTREAM Atherectomy Catheters
Boston Scientific is voluntarily removing three lots of JETSTREAM atherectomy catheters because some units were mislabeled with incorrect sizes.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (mislabeling) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Boston Scientific Corporation is initiating a voluntary removal of three lots of JETSTREAM atherectomy catheters. The affected products include two lots of JETSTREAM SC 1.85mm and one lot of JETSTREAM XC 2.1mm catheters. These devices are designed for use in treating vascular disease in the peripheral vasculature.
The recall is due to labeling errors where some 1.85mm JETSTREAM SC catheters may have been labeled as 2.1mm catheters, and some 2.1mm JETSTREAM XC catheters may have been labeled as 1.85mm catheters. The FDA has classified this as a Class II recall.
The affected units were distributed in the United States and in Germany, Great Britain, Poland, and the Netherlands. Healthcare providers and facilities should check their inventory for the specific lot codes 18775553, 18775552, and 18822086 and stop using any units that match these descriptions.
The recalled product
- Product
- The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking and treating vascular disease in the peripheral vasculature. The System includes multiple distal ports located at the catheter tip, which are designed to provide independent infusion and…
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 137
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 18775553
- 18775552
- 18822086
Distribution
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