Reported Jan 22, 2025 · Ongoing
Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2)…
ev3 Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ev3 Inc · 4600 Nathan Ln N · Plymouth, MN · 55442-2890
Is this the product you have?
20 of 20 products
| # | Product as published |
|---|---|
| 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 |
- Lot codes and dates
23 of 23 products
Products covered by this recall # Barcodes Product as published 1 00763000758035AB14W050020090, UDI/DI 00763000758035, Serial Numbers: B738596, B749440, B764968 2 00763000758042AB14W050020150, UDI/DI 00763000758042, Serial Numbers: B761521, B781264, B794814 3 00763000758059AB14W050040090, UDI/DI 00763000758059, Serial Numbers: B740725, B748628 4 04987742337891AB14W050040090, UDI/DI 04987742337891, Serial Numbers: B740725 5 00763000758066AB14W050040150, UDI/DI 00763000758066, Serial Numbers: B748644, B755679, B757663, B760286, B761769, B762343, B775924, B775972, B776408, B792995 6 04987742337907AB14W050040150, UDI/DI 04987742337907, Serial Numbers: B755679 7 00763000758080AB14W050060150, UDI/DI 00763000758080, Serial Numbers: B755683, B761779, B762646, B792990 8 00763000758097AB14W050080090, UDI/DI 00763000758097, Serial Numbers: B797860 9 00763000758103AB14W050080150, UDI/DI 00763000758103, Serial Numbers: B734091, B750081, B755684, B761172, B761754, B762256, B775959, B793874 10 AB14W050100150, UDI/DI none, Serial Numbers: B750054, B758860, B761368, B764977, B765527, B769645, B781316, B791878, B805118 11 00763000758141AB14W050120150, UDI/DI 00763000758141, Serial Numbers: B731160, B761782, B762036, B768737, B793229 12 00763000758165AB14W050150150, UDI/DI 00763000758165, Serial Numbers: B727462, B736200, B750625, B758294, B758866, B760303, B762032, B763323, B763333, B763355, B763360, B776072, B792620, B793222 13 00763000758172AB14W050200090, UDI/DI 00763000758172, Serial Numbers: B760301, B789934 14 04987742337815AB14W050200090, UDI/DI 04987742337815, Serial Numbers: B760301 15 00763000758189AB14W050200150, UDI/DI 00763000758189, Serial Numbers: B734116, B740732, B749498, B749509, B754865, B754876, B754889, B754921, B754938, B754944, B762313, B762346, B762623, B762814, B762967, B781392, B791857, B792372, B798527 16 00763000758219AB14W060040090, UDI/DI 00763000758219, Serial Numbers: B730934, B795892 17 00763000758226AB14W060040150, UDI/DI 00763000758226, Serial Numbers: B737344, B748659, B755681, B760297, B761167, B761194, B764136, B764985, B765532, B791881, B793013 18 00763000758240AB14W060060150, UDI/DI 00763000758240, Serial Numbers: B762430, B762853, B791832 19 00763000758264AB14W060080150, UDI/DI 00763000758264, Serial Numbers: B755686, B761181, B762366, B762433, B762921, B793869 20 00763000758288AB14W060100150, UDI/DI 00763000758288, Serial Numbers: B748690, B759617, B762803, B769628, B781383, B792612 - Amount recalled
- 5189 units
Where it was sold
- Nationwide
- PR
Why it was recalled
There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new ev3 Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.