Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
Reported: August 31, 2022 Initiated: August 9, 2022 #Z-1582-2022
Product Description
Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
Reason for Recall
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.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 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.
- Location
- Maple Grove, MN
Frequently Asked Questions
What product was recalled? ▼
Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440. Recalled by Boston Scientific Corporation. Units affected: 184 devices (UPDATED).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 31, 2022. Severity: Moderate. Recall number: Z-1582-2022.
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