Z-0729-04

Impulse 5F 145 (degree) Multipack Angiographic Catheters, Catalog Number H749163913011

Name: Z-0729-04 Impulse 5F 145 (degree) Multipack Angiographic Catheters, Catalog Number H749163913011
Creator: Boston Scientific Scimed
Published: 2004-02-13
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2004-02-13 / Terminated

FDA source

Boston Scientific Scimed began a recall of Impulse 5F 145 (degree) Multipack Angiographic Catheters, Catalog Number H749163913011 on 2004-02-13. The reason FDA records is "Some of the catheters may have yellow foreign material in their pigtail tips. The foreign material in the device could cause a stroke or significant damage to organs other than the brain". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0729-04
Status: Terminated
Initiated: 2004-02-13
Posted: 2004-07-20
Terminated: 2006-12-28
Recalling firm: Boston Scientific Corporation
Product: Impulse 5F 145 (degree) Multipack Angiographic Catheters, Catalog Number H749163913011
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: Some of the catheters may have yellow foreign material in their pigtail tips. The foreign material in the device could cause a stroke or significant damage to organs other than the brain.
FDA root cause: Other
Action: Consignees were sent a recall letter dated February 13, 2004. The letter requested that consignees discontinue use of the recalled catheters and return them.
Quantity in commerce: 11 catheters
Distribution: The product was shipped to consignees in Florida in the United States.
Product codes and lots: Lot Number 400934

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)