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RecallWatchMedical Device Safety
Class IIOngoingZ-0904-2025

Ev3 Inc recalls Medtronic NanoCross Elite PTA catheter

ev3 IncPlymouth, MN, United StatesReported Jan 22, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

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

Lot / code information

Serial #
B738596, B749440, B764968; 2) AB14W050020150, UDI/DI 00763000758042
Serial #
B761521, B781264, B794814; 3) AB14W050040090, UDI/DI 00763000758059
Serial #
B740725, B748628; 3) AB14W050040090, UDI/DI 04987742337891
Serial #
B740725; 4) AB14W050040150, UDI/DI 00763000758066
Serial #
B748644, B755679, B757663, B760286, B761769, B762343, B775924, B775972, B776408, B792995; 4) AB14W050040150, UDI/DI 04987742337907
Serial #
B755679; 5) AB14W050060150, UDI/DI 00763000758080
Serial #
B755683, B761779, B762646, B792990; 6) AB14W050080090, UDI/DI 00763000758097
Serial #
B797860; 7) AB14W050080150, UDI/DI 00763000758103
Serial #
B734091, B750081, B755684, B761172, B761754, B762256, B775959, B793874; 8) AB14W050100150, UDI/DI none
Serial #
B750054, B758860, B761368, B764977, B765527, B769645, B781316, B791878, B805118; 9) AB14W050120150, UDI/DI 00763000758141
Show 13 more code fields
Serial #
B731160, B761782, B762036, B768737, B793229; 10) AB14W050150150, UDI/DI 00763000758165
Serial #
B727462, B736200, B750625, B758294, B758866, B760303, B762032, B763323, B763333, B763355, B763360, B776072, B792620, B793222; 11) AB14W050200090, UDI/DI 00763000758172
Serial #
B760301, B789934; 11) AB14W050200090, UDI/DI 04987742337815
Serial #
B760301; 12) AB14W050200150, UDI/DI 00763000758189
Serial #
B734116, B740732, B749498, B749509, B754865, B754876 — +14 moreShow all
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 #
B730934, B795892; 14) AB14W060040150, UDI/DI 00763000758226
Serial #
B737344, B748659, B755681, B760297, B761167, B761194, B764136, B764985, B765532, B791881, B793013; 15) AB14W060060150, UDI/DI 00763000758240
Serial #
B762430, B762853, B791832; 16) AB14W060080150, UDI/DI 00763000758264
Serial #
B755686, B761181, B762366, B762433, B762921, B793869; 17) AB14W060100150, UDI/DI 00763000758288
Serial #
B748690, B759617, B762803, B769628, B781383, B792612; 18) AB14W060120150, UDI/DI 00763000758301
Serial #
B762187, B766265, B789926; 19) AB14W060150150, UDI/DI 00763000758325
Serial #
B730835, B734241, B757655, B758869, B761533, B776389, B781300, B791875; 20) AB14W060200150, UDI/DI 00763000758349
Serial #
B726348, B736196, B749504, B750650, B754900, B761765, B762193, B769612, B769616, B769622, B769634, B781989, B792379

What the firm is doing

Medtronic issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 12/10/2024 via mail courier. The notice explained the issue, potential harms, and requested the following actions be taken: "" Immediately locate and quarantine all affected and unused NanoCross devices as listed in the provided scope. " Return all unused affected products in your inventory to Medtronic. Contact Medtronic Vascular Customer Service at 800-716-6700 to initiate a product return. Your local Medtronic Representative can assist you with the initiation of the return. " Complete and return the Customer Confirmation Form enclosed with this letter, acknowledging that you have received this information, and return it to RS.CFQFCA@medtronic.com within 30-days of receipt of this letter. " Please forward this notice to all those who need to be aware within your organization and maintain a copy for your records."

DistributionShow details

Worldwide distribution - US (& PR) Nationwide and the countries of Chile, Cyprus, Estonia, Germany, Italy, Japan, Jordan, Puerto Rico, Spain, United States, Uzbekistan, and Yemen.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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