Z-0666-03

Medi-Tech Magic Torque Glidex hydrophilic coated guidewire, .035 inch/180 cm and .035 inch/260 cm lengths...

Name: Z-0666-03 Medi-Tech Magic Torque Glidex hydrophilic coated guidewire, .035 inch/180 cm and .035 inch/260 cm lengths...
Creator: Symbiosis Corp.
Published: 2002-11-27
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2002-11-27 / Terminated / root cause: labeling and UDI

FDA source

Symbiosis Corp. began a recall of Medi-Tech Magic Torque Glidex hydrophilic coated guidewire, .035 inch/180 cm and .035 inch/260 cm lengths. Packaged in a sterile pouch and a three pack shelf... on 2002-11-27. The reason FDA records is "The 180 cm guidewire is mislabeled as 260 cm and the 260 cm guidewire is mislabeled as 180 cm". 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-0666-03
Status: Terminated
Initiated: 2002-11-27
Posted: 2003-03-20
Terminated: 2012-07-13
Recalling firm: Boston Scientific Corporation
Product: Medi-Tech Magic Torque Glidex hydrophilic coated guidewire, .035 inch/180 cm and .035 inch/260 cm lengths. Packaged in a sterile pouch and a three pack shelf box.
Product code: DQX Wire, Guide, Catheter
Reason for recall: The 180 cm guidewire is mislabeled as 260 cm and the 260 cm guidewire is mislabeled as 180 cm.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: A Recall Notification Letter was send to hospitals via Federal Express Overnight Delivery, on 11/27/2002 to the attention of the Risk Manager and the Cath Lab Manager. In addition a response form was included. Recalled units are to be returned to the Boston Scientific Distribution Center located at 500 Commander Shea Blvd., Quincy, MA 02171.
Quantity in commerce: 286
Distribution: Product was distributed to 118 hospitals nationwide.
Product codes and lots: Pouch codes for the 180 cm length wuidewires are: Catalog No. 46-591, UPN M001465910 Lot Number Use Before Date 4959940 2005-08 4959941 '' 4969651 '' 4969654 '' 4969655 '' 4969656 '' The pouch codes for the 260 cm length guidewires are: Catalog No. 46-5912, UPN M001465920 Lot Number Use Before Date 4959945 2005-08 4959946 '' 4959944 '' 4959943 ''

Product code DQX

K933334Class IIMagic Torque GuidewireBoston Scientific Corp / cleared 1994-01-26

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)