Z-0642-2007

Boston Scientific Medi-Tech(R) Katzen (TM) Infusion Wire, for the infusion of therapeutic agents (i.e...

Name: Z-0642-2007 Boston Scientific Medi-Tech(R) Katzen (TM) Infusion Wire, for the infusion of therapeutic agents (i.e...
Creator: Boston Scientific
Published: 2006-12-12
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2006-12-12 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific began a recall of Boston Scientific Medi-Tech(R) Katzen (TM) Infusion Wire, for the infusion of therapeutic agents (i.e. heparin, saline, thrombolytic agents, etc.) in the... on 2006-12-12. The reason FDA records is "Boston Scientific is voluntarily recalling one lot/batch of Katzen Infusion Wires because they have identified that the label on the carton may indicate a different length device than what is actually in the carton. The...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0642-2007
Status: Terminated
Initiated: 2006-12-12
Posted: 2007-03-21
Terminated: 2007-07-20
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific Medi-Tech(R) Katzen (TM) Infusion Wire, for the infusion of therapeutic agents (i.e. heparin, saline, thrombolytic agents, etc.) in the peripheral vasculature. The wire allows for the delivery of agents in either a 'pulse-spray' or 'slow weep' technique. Order No. REF: 46-193 (M001461930).
Product code: DQX Wire, Guide, Catheter
Reason for recall: Boston Scientific is voluntarily recalling one lot/batch of Katzen Infusion Wires because they have identified that the label on the carton may indicate a different length device than what is actually in the carton. The affected batch was manufactured using the Katzen Core Assembly of 146 cm, instead of a 177cm assembly.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: An Urgent Medical Device Recall letter, dated December 12, 2006 was sent to affected hospitals Risk Manager beginning 12/12/2006. The letter describes the issue and product affected, requests that further distribution or use of any remaining product cease immediately, and provides information for returning product to Boston Scientific Replacement product will be issued for all recalled product returned from affected facilities. A Reply Verification Tracking Form is requested to be completed and returned to Boston Scientific by Wednesday, December 27, 2006.
Quantity in commerce: 10 units
Distribution: US only to: FL, GA, IN, NY.
Product codes and lots: Lot/Batch #: 9052739

Product code DQX

K883880Class IIKatzen Thrombolysis GuidewireMedi-Tech, Inc. / cleared 1989-04-06

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)