Medtronic NanoCross Elite PTA Catheter (Unknown) – Balloon Deflation Issue (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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)
Lot Codes / Batch Numbers
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.
Products Sold
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.
A medical device manufacturer is recalling Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 2 due to There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.
Recommended Action
Per FDA guidance
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."
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026