Boston Scientific Corporation MaxForce TTS High Performance Esophageal Balloon Dilatation Catheter 8mm/24 Fr Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MaxForce TTS High Performance Esophageal Balloon Dilatation Catheter 8mm/24 Fr
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
Catalog No. 8908 Lot Number: 5248945
Products Sold
Catalog No. 8908 Lot Number: 5248945
Boston Scientific Corporation is recalling MaxForce TTS High Performance Esophageal Balloon Dilatation Catheter 8mm/24 Fr due to Catheter is mislabeled as 8 mm/24 Fr instead of a 6 mm/18 Fr. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Catheter is mislabeled as 8 mm/24 Fr instead of a 6 mm/18 Fr
Recommended Action
Per FDA guidance
The firm notified each direct account by letter on 4/29/03 and, via letters of July 3 and July 11, 2003, extended the recall to three additional sizes of the catheter . Users were requested to check inventory, return the products to Boston Scientific and to reply regarding receipt of recall notification and the return of products.
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
CA, CO, FL, HI, IL, KY, LA, ME, MA, MI, NC, OH, PA, SC, TN, UT, VA, WA, WV
Page updated: Jan 10, 2026