Z-0831-03

MaxForce TTS High Performance Esophageal Balloon Dilatation Catheter 8mm/24 Fr

Name: Z-0831-03 MaxForce TTS High Performance Esophageal Balloon Dilatation Catheter 8mm/24 Fr
Creator: Boston Scientific Corporation
Published: 2003-04-29
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2003-04-29 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific Corporation began a recall of MaxForce TTS High Performance Esophageal Balloon Dilatation Catheter 8mm/24 Fr on 2003-04-29. The reason FDA records is "Catheter is mislabeled as 8 mm/24 Fr instead of a 6 mm/18 Fr". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0831-03
Status: Terminated
Initiated: 2003-04-29
Posted: 2003-05-15
Terminated: 2004-03-11
Recalling firm: Boston Scientific Corporation
Product: MaxForce TTS High Performance Esophageal Balloon Dilatation Catheter 8mm/24 Fr
Product code: LIT Catheter, Angioplasty, Peripheral, Transluminal
Reason for recall: Catheter is mislabeled as 8 mm/24 Fr instead of a 6 mm/18 Fr
Root cause tag: labeling and UDI
FDA 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 in commerce: 27 units
Distribution: CA, CO, IL, FL, HI, KY, LA, MA, ME, MI, NC, OH, PA, SC, TN, UT, VA, WA, WV,
Product codes and lots: Catalog No. 8908 Lot Number: 5248945

Product code LIT

K934697Class IIMicrovasive MaxforceBoston Scientific Corp / cleared 1994-05-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)