Z-1805-2009

POWERSAIL Coronary Dilatation Catheter: 4.0x8mm (CE) Part #1005726-08

Name: Z-1805-2009 POWERSAIL Coronary Dilatation Catheter: 4.0x8mm (CE) Part #1005726-08
Creator: Abbott Vascular-Cardiac Therapies dba Guidant Corporation
Published: 2009-06-17
License: https://open.fda.gov/license/

Abbott Vascular / initiated 2009-06-17 / Terminated / root cause: manufacturing process

FDA source

Abbott Vascular-Cardiac Therapies dba Guidant Corporation began a recall of POWERSAIL Coronary Dilatation Catheter: 4.0x8mm (CE) Part #1005726-08 on 2009-06-17. The reason FDA records is "Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures". 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-1805-2009
Status: Terminated
Initiated: 2009-06-17
Posted: 2009-07-29
Terminated: 2010-07-06
Recalling firm: Abbott Vascular
Product: POWERSAIL Coronary Dilatation Catheter: 4.0x8mm (CE) Part #1005726-08
Product code: MAF Stent, Coronary
Reason for recall: Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Abbott Vascular sent an Urgent Device Recall letter (w/return form) to customers on June 17, 2009 requesting return of identified products to Abbott Vascular Territory Manager. Abbott Vascular issued a press release dated July 28, 2009.
Quantity in commerce: 557 total devices
Distribution: Worldwide: United States, Australia, Belguim, Canada, China, Czech Republic, France, Germany, Greece, India, Italy, Japan, Jordan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Spain, Sri Lanka, Switzerland, Thailand, and United Kingdom.
Product codes and lots: Lot 7112051(exp 10-2009)

Product code MAF

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)