Z-1034-03

Fibered Platinum Coil, 0.035 Type, 9 mm x 60 mm Catalog no. 372906

Name: Z-1034-03 Fibered Platinum Coil, 0.035 Type, 9 mm x 60 mm Catalog no. 372906
Creator: Boston Scientific Corporation
Published: 2003-06-23
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2003-06-23 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific Corporation began a recall of Fibered Platinum Coil, 0.035 Type, 9 mm x 60 mm Catalog no. 372906 on 2003-06-23. The reason FDA records is "Product 's Outer box label may not match pouch label: a 4mm x 30 mm coil may be labeled as a 9 mm x 60 mm or vice versa". 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-1034-03
Status: Terminated
Initiated: 2003-06-23
Posted: 2003-07-19
Terminated: 2018-10-03
Recalling firm: Boston Scientific Corporation
Product: Fibered Platinum Coil, 0.035 Type, 9 mm x 60 mm Catalog no. 372906
Reason for recall: Product 's Outer box label may not match pouch label: a 4mm x 30 mm coil may be labeled as a 9 mm x 60 mm or vice versa
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Boston Scientific notified sales representatives on 6/23/03 in foreign distribution area to remove product from inventory and contact hospital to retrieve and return.
Quantity in commerce: 30 units
Distribution: Japan, Italy, France, Turkey, Israel, Finland
Product codes and lots: Lot Number: 5472234

K955293Class IIFibered Platinum Coil, .035 TypeTarget Therapeutics / cleared 1996-02-06

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)