C315-HIS Delivery Catheter recallZ-0173-2022 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · initiated Sep 9, 2021
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.
FDA root cause category: Under Investigation by firm
What the company is doing
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 [email protected]. 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 product return. Your local Medtronic Representative can assist you in the return of this product. o Note: Root cause is under investigation for this issue. Return of the identified product will aid the investigation. Please complete the enclosed Customer Confirmation Form and email to [email protected]." The letter also instructs the consignee to share the notice with all those who need to be made aware with their organization or to any organization where the potentially affected products have been transferred.
Recall details
- Recall number
- Z-0173-2022
- Status
- Open, Classified
- Initiated by the company
- Sep 9, 2021
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Quantity
- 591 units
- Product code
- DQY
- FDA submissions
- K101885
- Distribution
- Distributed internationally to Australia, Brunei Darussalam, China, Germany, Hong Kong, Indonesia, Malaysia, Netherlands, Singapore, and Taiwan.
Product description
C315-HIS Delivery Catheter
Code information (models, lots, serial numbers)
GTIN: 00763000160180; Model: C315HIS02 (Serial Number/Lot Number: 0010567341), C315HIS03 (Serial Number/Lot Number: 10568899), and C315HIS04 (Serial Number/Lot Number: 10568900)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NA C315HIS02Medtronic, Inc. · Catheter, percutaneous1 recall369 reports
Other devices under the same FDA submission
2 devices cleared under K101885 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- NA C315HIS02Medtronic, Inc. · CATHETER, PERCUTANEOUS79 reports
- NA C315H4002Medtronic, Inc. · CATHETER, PERCUTANEOUS1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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