FDA Medical Device Recalls (openFDA)
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 number
- Z-0120-2010
- Recalling firm
- Thomas Medical Products Inc
- Product
- Reinforced Catheter Introducer System, 5 per carton. The product is sold under the Cordis Crossover and Cardiovascular Systems Inc (CSI) ViperSheath labels.
- Status
- Terminated
- Initiated
- 2009-10-21
- Posted
- 2009-11-24
- Terminated
- 2010-11-08
- Reason
- Sheath may break or fracture which may cause vessel damage or require surgical intervention to retrieve catheter pieces.
- Root cause
- Component design/selection
- Action
- 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.
- Quantity
- 17,236 units
- Distribution
- United States (FL and MN).
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K083269"]
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 3010665433
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28