Medtronic FlexCath Select Steerable Sheath Recalled for Valve Debris
Medtronic is recalling 151 FlexCath Select Steerable Sheaths because clinicians observed debris originating from the hemostasis valve outside of patients' bodies.
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: The recall involves a high-risk medical device where a physical hazard (debris) was observed, but the source text does not report any specific injuries, illnesses, or fatalities, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
Medtronic Inc. Cardiac Rhythm Disease Management is recalling the 10 Fr FlexCath Select Steerable Sheath (Catalog Number 990065). This single-use, non-implantable device is used for percutaneous catheter introduction into the vasculature and chambers of the heart. The recall involves 151 units, with 4 distributed in the United States and 147 distributed outside the United States.
The recall was initiated after clinicians observed debris appearing to originate from the hemostasis valve on the proximal end of the sheath outside of patients' bodies. The affected lot numbers are 54790, 54860, 54876, 54877, 54878, 72417, and 72419.
Distribution occurred in the United States (North Carolina and Iowa) and in Austria, Belgium, Denmark, France, Germany, the Netherlands, Poland, Spain, and the United Kingdom. Healthcare providers should stop using the affected devices and contact Medtronic for instructions on return or replacement.
The recalled product
- Product
- Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable Sheath (10 Fr Select) is used for percutaneous catheter introduction into the vasculature and chambers of the heart. The sheath is a single-use device and is not implantable.
- Manufacturer
- Medtronic Inc. Cardiac Rhythm Disease Management
- Hazard
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 (7)
- Lot Number: 54790
- 54860
- 54876
- 54877
- 54878
- 72417
- 72419.
Distribution
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