Medtronic recalls C315-HIS Delivery Catheters due to functional defect
Medtronic is recalling 591 units of C315-HIS Delivery Catheters due to reports that a lead cannot pass through the catheter. The catheters were distributed internationally to multiple countries, and healthcare providers should contact Medtronic for guidance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with no reported illnesses or injuries. The functional defect presents a risk of harm but no adverse events have been reported, corresponding to Score 3 for risk-of-harm products without reported injury.
Plain-English summary
Medtronic Inc., Cardiac Rhythm and Heart Failure division, is recalling three lots of unused C315-HIS Delivery Catheters due to reports of an inability to pass a lead through the device. The recall affects 591 units distributed to Australia, Brunei Darussalam, China, Germany, Hong Kong, Indonesia, Malaysia, Netherlands, Singapore, and Taiwan.
The affected models and lot numbers are: C315HIS02 (Lot 0010567341), C315HIS03 (Lot 10568899), and C315HIS04 (Lot 10568900).
Healthcare providers and facilities that received this product should contact Medtronic for guidance regarding the affected units.
The recalled product
- Product
- C315-HIS Delivery Catheter
- Hazard
- Affected units
- 591
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- GTIN: 00763000160180
- Model: C315HIS02 (Serial Number/Lot Number: 0010567341)
- C315HIS03 (Serial Number/Lot Number: 10568899)
- and C315HIS04 (Serial Number/Lot Number: 10568900)
Distribution
Distribution scope not specified by the agency.
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