C315-HIS Delivery Catheter
Reported: November 3, 2021 Initiated: September 9, 2021 #Z-0173-2022
Product Description
C315-HIS Delivery Catheter
Reason for Recall
Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.
Details
- Recalling Firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Units Affected
- 591 units
- Distribution
- Distributed internationally to Australia, Brunei Darussalam, China, Germany, Hong Kong, Indonesia, Malaysia, Netherlands, Singapore, and Taiwan.
- Location
- Mounds View, MN
Frequently Asked Questions
What product was recalled? ▼
C315-HIS Delivery Catheter. Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF). Units affected: 591 units.
Why was this product recalled? ▼
Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 3, 2021. Severity: Moderate. Recall number: Z-0173-2022.
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