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Terminated

The product is a stainless steel stent mounted on a PTA balloon delivery device. The product is indicated for the palliation of malignant neoplasms in the biliary tree. The product is labeled as Edwards Lifesciences, LifeStent LP SDS, Biliary Endoprosthesis. Manufactured by ORBUS, MEDICAL TECHNOLOGIES. 5363 NW 35th Ave, Fort Lauderdale, FL, 33309. Ph 954 730-071, www. orbus.com. Distributed by: Edwards Lifesciences, Irvine, CA 82014-5888. Ref. Baloon-Expandable Stent and delivery System. Catalog Numbers SD186U14D SD186U24D SD366U14D SD366U24D

FDA Recall Z-1075-04 · Posted 2004-07-20

Recalling FirmOrbus Medical Technologies Inc
Recall StatusTerminated
Product CodeMEW
Date Initiated2004-03-19
Date Terminated2012-07-08
Product Quantity22

Reason for Recall

BALLOONS HAVE LONGER THAN EXPECTED DEFLATION TIMES.

Firm Action

Orbus, the recalling firm issued a recall letter on March,19 2004 to their own label distributer, Edwards Lifesciences, requesting the return of unused product. Also Orbus provided the own label distributer with a sample sub-recall letter for them to send to users/hospital accounts. Sub-accounts were asked to return product to Edwards Lifesciences.

Root Cause

Other

Distribution Pattern

Product was shipped to one own label distributer in California.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023248LIFESTENT LP SDS BILIARY ENDOPROSTHESISOrbus Medical Technologies · 2003-02-11

Official Source

View FDA Recall →

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

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