Thomas Medical Products Inc Reinforced Catheter Introducer System, 5 per carton. The product is sold under the Cordis Crossover and Cardiovascular Systems Inc (CSI) ViperSheath labels. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Reinforced Catheter Introducer System, 5 per carton. The product is sold under the Cordis Crossover and Cardiovascular Systems Inc (CSI) ViperSheath labels.
Brand
Thomas Medical Products Inc
Lot Codes / Batch Numbers
Cordis lot numbers - U0000025, U0000026, U0000027, U0000028, U0000029, U0000030, U0000031, U0000032, U0000033, U0000034, U0000035, U0000036, U0000037, U0000038, U0000039, U0000040, U0000041, U0000042, U0000043, U0000044, U0000045, U0000046, U0000047, U0000048, U0000049, U0000050, U0000051, U0000052, U0000053, U0000054, U0000055, U0000056, U0000057, U0000058, U0000059, U0000060, U0000061, and U0000062. CSI lot numbers - S28117, S28118, S28119, S28127, S28150, S28151, S28727, S28728, S28777, S28778, S28779, S28787, S28804, S28898, S28945, S28967, S29174, S29175, and S29528.
Products Sold
Cordis lot numbers - U0000025, U0000026, U0000027, U0000028, U0000029, U0000030, U0000031, U0000032, U0000033, U0000034, U0000035, U0000036, U0000037, U0000038, U0000039, U0000040, U0000041, U0000042, U0000043, U0000044, U0000045, U0000046, U0000047, U0000048, U0000049, U0000050, U0000051, U0000052, U0000053, U0000054, U0000055, U0000056, U0000057, U0000058, U0000059, U0000060, U0000061, and U0000062. CSI lot numbers - S28117, S28118, S28119, S28127, S28150, S28151, S28727, S28728, S28777, S28778, S28779, S28787, S28804, S28898, S28945, S28967, S29174, S29175, and S29528.
Thomas Medical Products Inc is recalling Reinforced Catheter Introducer System, 5 per carton. The product is sold under the Cordis Crossover due to Sheath may break or fracture which may cause vessel damage or require surgical intervention to retrieve catheter pieces.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Sheath may break or fracture which may cause vessel damage or require surgical intervention to retrieve catheter pieces.
Recommended Action
Per FDA guidance
An "Urgent Medical Device Correction" letter dated October 22, 2009 was issued to the direct accounts. The letter described the problem and actions for consignees. Consignees were instructed to cease distribution of the recalled product and to notify their subaccounts of the problem. In addition, customers were instructed to return the affected, unused product to Thomas Medical Product, Inc.'s contract warehouse, Inner-Space Warehouse, Inc. Contact your local sales representative for questions about the recall, or Customer Service by calling 1-866-446-3003, Monday through Friday from 8:30AM to 5:OOPM Eastern Standard Time, for questions about product return.
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