Abbott Vascular-Cardiac Therapies dba Guidant Corporation POWERSAIL Coronary Dilatation Catheter: 3.25x18mm (US) Part #1005524-18 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
POWERSAIL Coronary Dilatation Catheter: 3.25x18mm (US) Part #1005524-18
Brand
Abbott Vascular-Cardiac Therapies dba Guidant Corporation
Lot Codes / Batch Numbers
Lot 7101051 (exp 09-2009)
Products Sold
Lot 7101051 (exp 09-2009)
Abbott Vascular-Cardiac Therapies dba Guidant Corporation is recalling POWERSAIL Coronary Dilatation Catheter: 3.25x18mm (US) Part #1005524-18 due to Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026