Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Reported: October 11, 2023 Initiated: July 27, 2023 #Z-0009-2024
Product Description
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Reason for Recall
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 4990 units
- Distribution
- US Nationwide distribution in the state of Indiana.
- Location
- Maple Grove, MN
Frequently Asked Questions
What product was recalled? ▼
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter. Recalled by Boston Scientific Corporation. Units affected: 4990 units.
Why was this product recalled? ▼
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 11, 2023. Severity: Moderate. Recall number: Z-0009-2024.
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