Z-1075-04

The product is a stainless steel stent mounted on a PTA balloon delivery device. The product is indicated for...

Name: Z-1075-04 The product is a stainless steel stent mounted on a PTA balloon delivery device. The product is indicated for...
Creator: Orbus Medical Technologies Inc
Published: 2004-03-19
License: https://open.fda.gov/license/

Orbusneich Medical, Inc. / initiated 2004-03-19 / Terminated

FDA source

Orbus Medical Technologies Inc began a recall of 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... on 2004-03-19. The reason FDA records is "BALLOONS HAVE LONGER THAN EXPECTED DEFLATION TIMES". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1075-04
Status: Terminated
Initiated: 2004-03-19
Posted: 2004-07-20
Terminated: 2012-07-08
Recalling firm: Orbusneich Medical, Inc.
Product: 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
Product code: MEW
Reason for recall: BALLOONS HAVE LONGER THAN EXPECTED DEFLATION TIMES.
FDA root cause: Other
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.
Quantity in commerce: 22
Distribution: Product was shipped to one own label distributer in California.
Product codes and lots: Lot numbers, FA0311031, FA0311032, FA0311034, FA0311035, FA0312026, FA0312034, FA0312041, FA0312042, FA0312051, FA0312052, FA0401006, FA0401019, FA0401026, FA0402026

Product code MEW

K023248Class IILifestent Lp Sds Biliary EndoprosthesisOrbus Medical Technologies / cleared 2003-02-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)