Boston Scientific Recalls PT Graphix Magnet J-TIP Guidewires Due to Tip Defect
Boston Scientific is voluntarily recalling PT Graphix Magnet J-TIP Guidewires because the wires are straight instead of having the pre-formed J-tip.
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 a voluntary precautionary measure for a labeling/shape discrepancy that results in a limited procedure delay, fitting the criteria for a moderate severity score.
Plain-English summary
Boston Scientific Corporation is voluntarily implementing a Class II medical device recall for one batch of PT Graphix Magnet J-TIP Guidewires with ICE Hydrophilic Coating. The affected product is identified by Lot 17971870 and includes 47 units. The guidewires are labeled as a J-tip model but are actually straight and do not have the pre-formed J-tip.
The recall covers units distributed in the states of Maine, Louisiana, and Tennessee. The most severe injury expected to occur is a limited procedure delay caused by the need to replace the guidewire with one that has the correct tip shape. No other injuries or illnesses are reported in the source text.
Healthcare providers should check their inventory for this specific lot number and stop using the affected guidewires. Patients who have had procedures using these devices should contact their healthcare provider if they have concerns.
The recalled product
- Product
- Boston Scientific, PT Graphix Magnet J-TIP Guidewire with ICE Hydrophilic Coating, Sterile EO, UPN H7491490201MJ2 (Carton Label) ,H7491490201MJo (UPN referenced on the Pouch Label) . Boston Scientific PT Graphix Magnet Guidewire with ICE Hydrophilic Coating is a steerable…
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Guidewire
- Affected units
- 47
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 (1)
- Lot: 17971870
Distribution
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