Abbott NC Tenku RX Balloon Catheter Recall for Sheath Removal Issues
Abbott Vascular is recalling NC Tenku RX PTCA Balloon Catheters because the protective sheath may be difficult to remove, potentially affecting balloon inflation or deflation.
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 medical device with a functional defect that could impact the performance of a procedure, representing a risk-of-harm product where specific injury reports are not detailed in the source text.
Plain-English summary
Abbott Vascular is recalling specific lots of NC Tenku RX PTCA Balloon Catheters. The recall involves 449,661 units total, with 132,040 units distributed in the United States and the remainder distributed worldwide.
The recall was initiated because products from the identified lots may exhibit difficulty in removing the protective balloon sheath. This issue can result in problems with inflating or deflating the balloon during use.
Healthcare providers and facilities that have received these devices should check their inventory against the specific part numbers and lot numbers listed in the official recall notice. Patients who have had these devices implanted should contact their healthcare provider for guidance.
The recalled product
- Product
- NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T, 1012448-15T, 1012449-08T, 1012449-12T, 1012449-15T, 1012450-08T, 1012450-12T, 1012450-15T, 1012451-08T, 1012451-12T, 1012451-15T, 1012452-08T, 1012452-12T, 1012452-15T, 1012453-08T, 1012453-12T
- Manufacturer
- Abbott Vascular
- Category
- Medical Device — Cardiovascular
- Hazard
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Abbott Vascular under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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