Medtronic NanoCross Elite PTA Catheter Recall Due to Balloon Deflation
Medtronic's NanoCross Elite PTA catheters in certain lots may not deflate properly during use. The FDA is recalling 5,189 units due to potential in-vivo balloon deflation issues.
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 an FDA Class II recall for a theoretical hazard with no reported illnesses or injuries. The potential for balloon deflation in a PTA catheter represents a risk-of-harm scenario, but without reported clinical consequences, the severity is capped at High per the rubric.
Plain-English summary
Medtronic's NanoCross Elite PTA catheter is a balloon dilatation catheter used in percutaneous transluminal angioplasty procedures. The FDA has issued a Class II recall for 5,189 units in specific reference numbers and serial lots.
The recall is due to a potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific affected lots. This condition may compromise device function during medical procedures.
The affected catheters have been distributed worldwide, including the United States and Puerto Rico, as well as Chile, Cyprus, Estonia, Germany, Italy, Japan, Jordan, Spain, Uzbekistan, and Yemen. Specific affected reference numbers are identified in the FDA recall notice, with corresponding serial numbers listed for each reference number.
The recalled product
- Product
- Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X 20MM X 150CM; 3) AB14W050040090, Size: 5MM X 40MM X 90CM; 4) AB14W050040150, Size: 5MM X 40MM X 150CM; 5) AB14W050060150,
- Manufacturer
- ev3 Inc
- Hazard
- balloon-deflation
- device-malfunction
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 (20)
- 1) AB14W050020090
- UDI/DI 00763000758035
- Serial Numbers: B738596
- B749440
- B764968
- 2) AB14W050020150
- UDI/DI 00763000758042
- Serial Numbers: B761521
- B781264
- B794814
- 3) AB14W050040090
- UDI/DI 00763000758059
- Serial Numbers: B740725
- B748628
- UDI/DI 04987742337891
- 4) AB14W050040150
- UDI/DI 00763000758066
- Serial Numbers: B748644
- B755679
- B757663
Distribution
Distributed nationwide across the United States.
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