Z-1160-2007

Boston Scientific Impulse Flextrusion Shaft 5F FL4 16391-22 H74916391222, (5-Pack Carton Label), Angiographic...

Name: Z-1160-2007 Boston Scientific Impulse Flextrusion Shaft 5F FL4 16391-22 H74916391222, (5-Pack Carton Label), Angiographic...
Creator: Boston Scientific Corporation
Published: 2007-06-04
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2007-06-04 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of Boston Scientific Impulse Flextrusion Shaft 5F FL4 16391-22 H74916391222, (5-Pack Carton Label), Angiographic Catheters. Made in Mexico Parque Industrial La... on 2007-06-04. The reason FDA records is "Labels on the carton from two batches/lots of Impulse Angiographic Catheters may indicate a different curve style than the device that is actually in the carton". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1160-2007
Status: Terminated
Initiated: 2007-06-04
Posted: 2007-08-09
Terminated: 2007-12-19
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific Impulse Flextrusion Shaft 5F FL4 16391-22 H74916391222, (5-Pack Carton Label), Angiographic Catheters. Made in Mexico Parque Industrial La Mesa Edificio G1, Suites B, H Tijuana, Baja California 22650 MEX Boston Scientific Impulse Flextrusion Shaft 5F FL4 16391-22 H74916391221, (Single Pack Carton/Pouch Label), Angiographic Catheters. Made in Mexico Parque Industrial La Mesa Edificio G1, Suites B, H Tijuana, Baja California 22650 MEX
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: Labels on the carton from two batches/lots of Impulse Angiographic Catheters may indicate a different curve style than the device that is actually in the carton.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Sales Force were contacted of the product and problem via voice mail and a memo dated June 4, 2007. Customers were contacted via a letter on June 4, 2007.
Quantity in commerce: 233
Distribution: Worldwide, including USA, Austria, Australia, Belgium, Chile, Germany, Spain, Finland, France, Great Britain, Greece, Ireland, Panama, Poland, Sweden, Thailand, and South Africa.
Product codes and lots: 688277

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)