Recall archive / FDA device enforcement
Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W05... — FDA record Z-0904-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 10, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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, Size: 5MM X 60MM X 150CM; 6) AB14W050080090, Size: 5MM X 80MM X 90CM; 7) AB14W050080150, Size: 5MM X 80MM X 150CM; 8) AB14W050100150, Size: 5MM X 100MM X 150CM; 9) AB14W050120150, Size: 5MM X 120MM X 150CM; 10) AB14W050150150, Size: 5MM X 150MM X 150CM; 11) AB14W050200090, Size: 5MM X 200MM X 90CM; 12) AB14W050200150, Size: 5MM X 200MM X 150CM; 13) AB14W060040090, Size: 6MM X 40MM X 90CM; 14) AB14W060040150, Size: 6MM X 40MM X 150CM; 15) AB14W060060150, Size: 6MM X 60MM X 150CM; 16) AB14W060080150, Size: 6MM X 80MM X 150CM; 17) AB14W060100150, Size: 6MM X 100MM X 150CM; 18) AB14W060120150, Size: 6MM X 120MM X 150CM; 19) AB14W060150150, Size: 6MM X 150MM X 150CM; 20) AB14W060200150, Size: 6MM X 200MM X 150CM; Balloon Dilatation Catheter
- Reason
- There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.
- Classification
- Class II
- Recalling firm
- ev3 Inc
- Quantity
- 5189 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0904-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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; 3) AB14W050040090, UDI/DI 04987742337891, Serial Numbers: B740725; 4) AB14W050040150, UDI/DI 00763000758066, Serial Numbers: B748644, B755679, B757663, B760286, B761769, B762343, B775924, B775972, B776408, B792995; 4) AB14W050040150, UDI/DI 04987742337907, Serial Numbers: B755679; 5) AB14W050060150, UDI/DI 00763000758080, Serial Numbers: B755683, B761779, B762646, B792990; 6) AB14W050080090, UDI/DI 00763000758097, Serial Numbers: B797860; 7) AB14W050080150, UDI/DI 00763000758103, Serial Numbers: B734091, B750081, B755684, B761172, B761754, B762256, B775959, B793874; 8) AB14W050100150, UDI/DI none, Serial Numbers: B750054, B758860, B761368, B764977, B765527, B769645, B781316, B791878, B805118; 9) AB14W050120150, UDI/DI 00763000758141, Serial Numbers: B731160, B761782, B762036, B768737, B793229; 10) AB14W050150150, UDI/DI 00763000758165, Serial Numbers: B727462, B736200, B750625, B758294, B758866, B760303, B762032, B763323, B763333, B763355, B763360, B776072, B792620, B793222; 11) AB14W050200090, UDI/DI 00763000758172, Serial Numbers: B760301, B789934; 11) AB14W050200090, UDI/DI 04987742337815, Serial Numbers: B760301; 12) AB14W050200150, UDI/DI 00763000758189, Serial Numbers: B734116, B740732, B749498, B749509, B754865, B754876, B754889, B754921, B754938, B754944, B762313, B762346, B762623, B762814, B762967, B781392, B791857, B792372, B798527; 13) AB14W060040090, UDI/DI 00763000758219, Serial Numbers: B730934, B795892; 14) AB14W060040150, UDI/DI 00763000758226, Serial Numbers: B737344, B748659, B755681, B760297, B761167, B761194, B764136, B764985, B765532, B791881, B793013; 15) AB14W060060150, UDI/DI 00763000758240, Serial Numbers: B762430, B762853, B791832; 16) AB14W060080150, UDI/DI 00763000758264, Serial Numbers: B755686, B761181, B762366, B762433, B762921, B793869; 17) AB14W060100150, UDI/DI 00763000758288, Serial Numbers: B748690, B759617, B762803, B769628, B781383, B792612; 18) AB14W060120150, UDI/DI 00763000758301, Serial Numbers: B762187, B766265, B789926; 19) AB14W060150150, UDI/DI 00763000758325, Serial Numbers: B730835, B734241, B757655, B758869, B761533, B776389, B781300, B791875; 20) AB14W060200150, UDI/DI 00763000758349, Serial Numbers: B726348, B736196, B749504, B750650, B754900, B761765, B762193, B769612, B769616, B769622, B769634, B781989, B792379. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US (& PR) Nationwide and the countries of Chile, Cyprus, Estonia, Germany, Italy, Japan, Jordan, Puerto Rico, Spain, United States, Uzbekistan, and Yemen.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jan 22, 2025
- Recall initiation date
- Dec 10, 2024
- Center classification date
- Jan 14, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.