Z-0945-2008

Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a...

Name: Z-0945-2008 Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a...
Creator: Boston Scientific
Published: 2007-11-20
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2007-11-20 / Terminated

FDA source

Boston Scientific began a recall of Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery... on 2007-11-20. The reason FDA records is "Flash may be protruding from the lumen of the catheter shaft. If this flash is present in the catheter, there is the potential of an embolization resulting from the flash detaching from the device during the procedure". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0945-2008
Status: Terminated
Initiated: 2007-11-20
Posted: 2008-01-31
Terminated: 2008-10-23
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-03. 6F FR5 (5-pack). Distal curve FR5. 100 cm length. Made in Mexico: Parque industrial Le Mesa, Tijuana, Baja California 22050 MEX. Boston Scientific Corporation, Natick, MA 01760-1537 USA.
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: Flash may be protruding from the lumen of the catheter shaft. If this flash is present in the catheter, there is the potential of an embolization resulting from the flash detaching from the device during the procedure.
FDA root cause: Release of Material/Component prior to receiving test results
Action: The firm sent an Urgent Medical Device Recall letter dated 11/20/2007, to all affected hospitals. The letter describes the defect with the catheters and Product Table information including UPNs, Catalog Numbers, Lot/Batch Numbers and Product Descriptions. The firm requests that further distribution or use of any remaining product affected by the recall should cease immediately. ****IMPORTANT INFORMATION: If it is a practice of the hospital to remove product from the outer carton and store on shelves in the inner-pouch only. Users are to review the Product Table carefully and consider both the inner and outer packaging product codes when search for affected/recalled product.****
Quantity in commerce: 211 total single units
Distribution: Nationwide Distribution including states of AL, CA, FL, GA, KS, KY, LA, MN, NV, OH, OK, PA, SD, TN, TX, and WI.
Product codes and lots: Catalog No./outer box Material No. (UPN) /inner pouch UPN /Lot (Batch) No. : 16599-03/H74916599032/H74916599030/0020036931

Product code DQO

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)