Galt Medical Recalls Boston Scientific Transcarotid Access Kits
Galt Medical Corporation is recalling 114,260 Boston Scientific Enhance Transcarotid/Peripheral Access Kits because black depth markings may detach from the outer sheath.
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 the hazard involves a component defect (detaching markings) without reported injuries or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Galt Medical Corporation is recalling 114,260 units of the Boston Scientific Enhance Transcarotid/Peripheral Access Kit (REF: SR-4F21G7D-MP). The recall involves specific components including the sheath with dilator, stiffen dilator, nitinol mandrel wire, needle, and extension tube with stopcock.
The recall was initiated because black depth markings may detach from the outer sheath of the coaxial dilator introducer component. The affected kits were distributed nationwide in the United States, specifically within the state of Minnesota.
Healthcare providers and facilities should check their inventory for the specific lot numbers listed in the recall notice and stop using the affected kits. Users should contact Galt Medical Corporation for further instructions on how to return or dispose of the recalled products.
The recalled product
- Product
- Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube with Stopcock
- Manufacturer
- Galt Medical Corporation
- Category
- Medical Device — Vascular Access
- Affected units
- 114,260
Distribution
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