FDA Medical Device Recalls (openFDA)
Abbott Vascular-Cardiac Therapies dba Guidant Corporation: POWERSAIL Coronary Dilatation Catheter: 3.25x8mm (US) Part #1005524-08
- Recall number
- Z-1807-2009
- Recalling firm
- Abbott Vascular-Cardiac Therapies dba Guidant Corporation
- Product
- POWERSAIL Coronary Dilatation Catheter: 3.25x8mm (US) Part #1005524-08
- Status
- Terminated
- Initiated
- 2009-06-17
- Posted
- 2009-07-29
- Terminated
- 2010-07-06
- Reason
- Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures.
- 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
- 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.
- Lot, serial or model codes
- Lot 8053061(exp 04-2010)
- 510(k) numbers
- not on file
- PMA numbers
- ["P810046"]
- Product code
- MAF
- Firm FEI
- 2024168
- Firm city
- Temecula
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28