Recall Z-0173-2022 ยท DQY Catheter, Percutaneous
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
C315-HIS Delivery Catheter
| Date | Sep 9, 2021 |
| Status | Open, Classified |
| Reason | Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter. |
| Root cause | Under Investigation by firm |
| Action | Written notification letter titled, "MEDICAL DEVICE RECALL C315HIS DELIVERY CATHETER" was sent to all consignees on 09/09/2021 via 2-day UPS delivery. The letter instructs the consignee to take the following actions: "Check your inventory for the catheters identified in Table 1 above. If the product has been consumed, please complete the enclosed Customer Confirmation Form and email to xxxxx@medtronic.com. No further actions are required. " If there is unused identified product in your inventory, quarantine and return it to Medtronic. Contact Medtronic Customer Service at xxxxxxx to initiate a |
| Quantity | 591 units |
| Distribution | Distributed internationally to Australia, Brunei Darussalam, China, Germany, Hong Kong, Indonesia, Malaysia, Netherlands, Singapore, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101885 | MEDTRONIC C315 DELIVERY CATHETER Medtronic, Inc., Sep 9, 2010 |