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Terminated

Medtronic AVE brand BridgeAssurant Balloon Expandable Stent Delivery System for Biliary Catheter;Model #s: FB720VF, FB730 VF, FB740 VF, FB760 VF, FB820VF, FB830VF, FB840VF, FB860VF; FB720VL, FB730VL, FB820VL, FB830VL; FB720F, FB730F, FB740F, FB760F, FB820F, FB830F, FB840F, FB860F; FB720L, FB730L, FB820L, FB830L

FDA Recall Z-0789-03 · Posted 2003-05-07

Recalling FirmMedtronic Ave Inc
Recall StatusTerminated
Product CodeFGE
Date Initiated2003-02-27
Date Terminated2003-09-22

Reason for Recall

During use, device may exhibit high insertional resistance which may result in device damage, kinking and subsequent balloon deflation difficulties.

Firm Action

A letter was sent to each US commercial accounts via UPS overnight mailing on Saturday, March 1st, 2003 for delivery on Monday, March 3rd 2003. The notification instructs firm''s customers to sequester product from the specific lot numbers so that firm''s rep could assist in removing the affected product.

Root Cause

Other

Distribution Pattern

Product was released for distribution to 446 consignees nationwide. The recall was appropriately extended to the user level; i.e., Clinics, hospitals and medical Centers who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.

Official Source

View FDA Recall →

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

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