Agency classClass IIOur severity:High FDA (Devices)·Z-0904-2025·Announced 2025-01-22

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.

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: 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)…
Manufacturer: ev3 Inc
Category: Medical Device — Cardiovascular Intervention
Hazard: balloon-deflation
device-malfunction
Affected units: 5,189

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.

The notice also names 1 state specifically:

Same manufacturer · ev3 Inc

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