Boston Scientific Guider Softip XF recall
Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
Why was Boston Scientific Guider Softip XF recalled?
The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 08714729202486, Lot/Batch 27339850, Use By 2021-05-18, and UPDATE: Lot/Batch 29308869, Use By 4/27/2025.
- Product
- Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 184 devices (UPDATED)
- Distribution
- International distribution in the countries of Greece, France, Germany, Italy, Brazil and South Korea. UPDATE: The devices were also distributed to Russia. There was no U.S. distribution.
- Recall date
- August 31, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)