CLASS II ONGOING Device recall · Reported 3 Nov 2021 · FDA Enforcement Report
C315-HIS Delivery Catheter recalled by Medtronic Inc., Cardiac
Medtronic Inc., Cardiac Rhythm and Heart Failure (Crhf) is recalling C315-HIS Delivery Catheter. The recall was initiated on 9 Sep 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0173-2022
- FDA event ID
- 88688
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (Crhf), Mounds View, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Sep 2021
- FDA classified
- 22 Oct 2021
- Reported
- 3 Nov 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 9 Sep 2021 | Recall initiated by company | |
| 22 Oct 2021 | Classified by FDA | +43 days |
| 3 Nov 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
C315-HIS Delivery Catheter
Where it was distributed
Distributed internationally to Australia, Brunei Darussalam, China, Germany, Hong Kong, Indonesia, Malaysia, Netherlands, Singapore, and Taiwan.
Questions about this recall
Why was it 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 lots are affected?
GTIN: 00763000160180; Model: C315HIS02 (Serial Number/Lot Number: 0010567341), C315HIS03 (Serial Number/Lot Number: 10568899), and C315HIS04 (Serial Number/Lot Number: 10568900)
Where was it sold?
Distributed internationally to Australia, Brunei Darussalam, China, Germany, Hong Kong, Indonesia, Malaysia, Netherlands, Singapore, and Taiwan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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