Recalls / —

—#27261

Product

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

FDA product code

LIT — Catheter, Angioplasty, Peripheral, Transluminal

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K934697

Affected lot / code info

Catalog No. 8908 Lot Number: 5248945

Why it was recalled

Catheter is mislabeled as 8 mm/24 Fr instead of a 6 mm/18 Fr

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Boston Scientific Corporation

Address

1 Boston Scientific Place, Natick, Massachusetts 01760

Distribution

Distribution pattern

CA, CO, IL, FL, HI, KY, LA, MA, ME, MI, NC, OH, PA, SC, TN, UT, VA, WA, WV,

Timeline

Recall initiated

2003-04-29

Posted by FDA

2003-05-15

Terminated

2004-03-11

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #27261. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.