FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: MaxForce TTS High Performance Esophageal Balloon Dilatation Catheter 8mm/24 Fr
- Recall number
- Z-0831-03
- Recalling firm
- Boston Scientific Corporation
- Product
- MaxForce TTS High Performance Esophageal Balloon Dilatation Catheter 8mm/24 Fr
- Status
- Terminated
- Initiated
- 2003-04-29
- Posted
- 2003-05-15
- Terminated
- 2004-03-11
- Reason
- Catheter is mislabeled as 8 mm/24 Fr instead of a 6 mm/18 Fr
- Root cause
- Other
- Action
- 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.
- Quantity
- 27 units
- Distribution
- CA, CO, IL, FL, HI, KY, LA, MA, ME, MI, NC, OH, PA, SC, TN, UT, VA, WA, WV,
- Lot, serial or model codes
- Catalog No. 8908 Lot Number: 5248945
- 510(k) numbers
- ["K934697"]
- PMA numbers
- not on file
- Product code
- LIT
- Firm FEI
- 3001451463
- Firm city
- Natick
- Firm state
- MA
- 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