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Terminated

WALLSTENT Endoprostheses with UNISTEP Plus Delivery System.

FDA Recall Z-1340-04 · Posted 2004-08-13

Recalling FirmBoston Scientific Scimed
Recall StatusTerminated
Product CodeJCT
Date Initiated2004-07-09
Date Terminated2007-01-05
Product Quantity82 units (H965402100) aa7 units (H965402100)

Reason for Recall

Specific lots of the WALLSTENT Endoprosthesis with UNISTEP Plus Delivery System were packaged without one of the three required directions for use.

Firm Action

Boston Scientific is notifying sales representatives and customers of recall along with instructions regarding the return of potentially affected product.

Root Cause

Other

Distribution Pattern

Inside the US only.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K992510WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEMBoston Scientific Corp · 1999-11-18

Official Source

View FDA Recall →

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

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