Z-0120-2010

Reinforced Catheter Introducer System, 5 per carton. The product is sold under the Cordis Crossover and...

Name: Z-0120-2010 Reinforced Catheter Introducer System, 5 per carton. The product is sold under the Cordis Crossover and...
Creator: Thomas Medical Products Inc
Published: 2009-10-21
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2009-10-21 / Terminated / root cause: design

FDA source

Thomas Medical Products Inc began a recall of Reinforced Catheter Introducer System, 5 per carton. The product is sold under the Cordis Crossover and Cardiovascular Systems Inc (CSI) ViperSheath labels on 2009-10-21. The reason FDA records is "Sheath may break or fracture which may cause vessel damage or require surgical intervention to retrieve catheter pieces". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0120-2010
Status: Terminated
Initiated: 2009-10-21
Posted: 2009-11-24
Terminated: 2010-11-08
Recalling firm: Merit Medical Systems, Inc.
Product: Reinforced Catheter Introducer System, 5 per carton. The product is sold under the Cordis Crossover and Cardiovascular Systems Inc (CSI) ViperSheath labels.
Product code: DYB Introducer, Catheter
Reason for recall: Sheath may break or fracture which may cause vessel damage or require surgical intervention to retrieve catheter pieces.
Root cause tag: design
FDA 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 in commerce: 17,236 units
Distribution: United States (FL and MN).
Product codes and lots: 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.

Product code DYB

K083269Class IICrossoverThomas Medical Products, Inc. / cleared 2009-02-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)