Cook, Inc. Cook ATB Advance PTA Dilatation Catheter, French size 5, rated burst pressure 15 atm, inflated diameter 7 mm, balloon length 4 cm, recommended introducer French size 6, sterile, REF (Global product no.) G26887, REF (order no.) ATB5-35-40-7-4.0. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Cook ATB Advance PTA Dilatation Catheter, French size 5, rated burst pressure 15 atm, inflated diameter 7 mm, balloon length 4 cm, recommended introducer French size 6, sterile, REF (Global product no.) G26887, REF (order no.) ATB5-35-40-7-4.0.
Brand
Cook, Inc.
Lot Codes / Batch Numbers
Lot 1820419.
Products Sold
Lot 1820419.
Cook, Inc. is recalling Cook ATB Advance PTA Dilatation Catheter, French size 5, rated burst pressure 15 atm, inflated diame due to Mislabeled as to size: The outer label reads 7-4.0 balloon, when the balloon is actually 5-2.0.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mislabeled as to size: The outer label reads 7-4.0 balloon, when the balloon is actually 5-2.0.
Recommended Action
Per FDA guidance
Consignees were notified via telephone on 2/28/07 and instructed to return the product.
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 noticeDistribution
As reported by FDA
IL, NC, SC
Page updated: Jan 10, 2026