Medtronic cardiac catheter system recalled due to sterility barrier defect
Medtronic recalls its C304-HIS cardiac catheter device due to potential sterility barrier defects in certain manufacturing lots. Approximately 1,385 devices distributed worldwide were affected.
What this means for you
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: This is a Class II medical device recall of an implantable cardiac device with a potential sterility barrier defect. No illnesses or injuries have been reported. Per the severity rubric, this is High (3) as it represents a risk-of-harm product where injury has not yet been reported, below the Severe (4) threshold which requires documented hospitalization or significant injury.
Plain-English summary
Medtronic Inc. is recalling the C304-HIS cardiac catheter device. The device is used to facilitate placement of transvenous devices near the bundle of His. Medtronic's internal processes identified that certain manufacturing lots may have an improperly sealed barrier that could potentially compromise device sterility.
Approximately 1,385 devices have been affected by this recall. The devices were distributed worldwide, including across the United States and multiple countries in Europe, the Middle East, and other regions.
The recalled product
- Product
- The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure, a deflectable catheter to introduce a transvenous device, a catheter dilator to facilitate deflectable catheter passage, and a guide catheter slitter to remove
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- sterility-compromise
- seal-defect
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 (13)
- Model Number: C304-HIS
- GTIN: 00763000147013
- Lot Numbers: 0010948864
- 0010953298
- 0010958150
- 0010961222
- 0010971148
- 0011017539
- 0011020263
- 0011022874
- 0011025202
- 0011028574
- 0011031177
Distribution
Distributed nationwide across the United States.
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