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Terminated

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

FDA Recall Z-0831-03 · Posted 2003-05-15

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeLIT
Date Initiated2003-04-29
Date Terminated2004-03-11
Product Quantity27 units

Reason for Recall

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

Firm 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.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K934697MICROVASIVE MAXFORCEBoston Scientific Corp · 1994-05-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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