Boston Scientific Guide Catheter Distributed With Wrong Tip Curve
Boston Scientific recalled 184 guide catheters manufactured with the wrong tip curve specification. Affected devices were distributed to Greece, France, Germany, Italy, Brazil, South Korea, and Russia, but not the U.S.
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 3/5 (High).
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: This is an FDA Class II recall of a guide catheter with a manufacturing specification defect. No illnesses or injuries are reported in the source. The recall involves a medical device used in procedural settings, placing it in the category of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Boston Scientific recalled 184 Guider Softip XF 8F guide catheters (model REF H965100440) due to a manufacturing defect. The affected devices were shipped with an MPXF tip curve shape instead of the 40XF tip curve shape specified for this device.
The recalled devices were distributed internationally to Greece, France, Germany, Italy, Brazil, South Korea, and Russia. There was no U.S. distribution. The affected lots include Batch 27339850 (use by 2021-05-18) and Batch 29308869 (use by 4/27/2025).
Healthcare providers in affected countries should verify whether they have devices from the recalled lots. Contact Boston Scientific Corporation with questions about return, replacement, or disposal of affected units.
The recalled product
- Product
- Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Guide Catheter
- Hazard
- Affected units
- 184
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 (5)
- UDI/DI 08714729202486
- Lot/Batch 27339850
- Use By 2021-05-18
- and UPDATE: Lot/Batch 29308869
- Use By 4/27/2025.
Distribution
Distribution scope not specified by the agency.
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