Device product
C315-HIS Delivery Catheter
Z-0173-2022
Product summary
- Event
- Event 88688
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 591 units
- Official record key
device-enforcement:Z-0173-2022
Official wording
Reason: Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.
Code information: GTIN: 00763000160180; Model: C315HIS02 (Serial Number/Lot Number: 0010567341), C315HIS03 (Serial Number/Lot Number: 10568899), and C315HIS04 (Serial Number/Lot Number: 10568900)
Distribution pattern: Distributed internationally to Australia, Brunei Darussalam, China, Germany, Hong Kong, Indonesia, Malaysia, Netherlands, Singapore, and Taiwan.
Derived failure modes
-
Unknown
Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.