Z-0718-2020Class II

LIFESTREAM Balloon Expandable Vascular Covered Stent . BARD PERIPHERAL VASCULAR. 6mm X 26mm X 80 Recommended...

Name: Z-0718-2020 LIFESTREAM Balloon Expandable Vascular Covered Stent . BARD PERIPHERAL VASCULAR. 6mm X 26mm X 80 Recommended...
Creator: Bard Peripheral Vascular Inc
Published: 2019-02-18
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2019-02-18 / Terminated / root cause: manufacturing process

FDA source

Bard Peripheral Vascular Inc began a recall of LIFESTREAM Balloon Expandable Vascular Covered Stent . BARD PERIPHERAL VASCULAR. 6mm X 26mm X 80 Recommended Introducer 6F (2.00mm) NP 8atm (811 kPa)... on 2019-02-18. FDA classified it as Class II and gives the reason as "Certain product code/lot number combinations may experience introducer sheath compatibility issues when used with a 6F introducer sheath. Using the affected balloon expandable vascular covered stents with a 6F...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0718-2020
Classification: Class II
Status: Terminated
Initiated: 2019-02-18
Posted: 2019-12-19
Terminated: 2021-04-28
Recalling firm: Bard Peripheral Vascular Inc
Product: LIFESTREAM Balloon Expandable Vascular Covered Stent . BARD PERIPHERAL VASCULAR. 6mm X 26mm X 80 Recommended Introducer 6F (2.00mm) NP 8atm (811 kPa) Recommended Guide wire .035" (0.89mm) RBP 12 atm (1216 kPa) RX Only Lot numbers begins with CMA or CMB. Product Code Stent Diameter Stent length Catheter Length LSM0800626 6mm 26 mm 80 cm LSM1350626 6 mm 26 mm 135 cm LSM0800637 6 mm 37 mm 80 cm LSM1350637 6 mm 37 mm 135 cm LSM0800726 7 mm 26 mm 80 cm LSM1350726 7 mm 26 mm 135 cm Product Usage: The LIFESTREAM Balloon Expandable Vascular Covered Stent is indicated for the treatment of atherosclerotic lesions in common and external iliac arteries with reference vessel diameters between 4.5 mm and 12.0 mm, and lesions lengths up to 100mm.
Product code: PRL Iliac Covered Stent, Arterial
Reason for recall: Certain product code/lot number combinations may experience introducer sheath compatibility issues when used with a 6F introducer sheath. Using the affected balloon expandable vascular covered stents with a 6F introducer sheath could result in difficulty or the inability to insert or advance the catheter through the introducer sheath. This could potentially lead to a slight prolongation of the procedure.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 02/18/19, Urgent Product Defect Correction Notices were mailed to customers informing them to upsize to a 7F introducer sheath and to add relabeling stickers over the 6F introducer sheath size indication on the label. In addition, customers were asked to complete and return the Response Form. In addition, if the affected product has been further distributed, immediate action was requested to contact that location, advise them of the field correction notice and to forward the Urgent Product Defect Correction Notice to the affected customer. Customers having additional questions are encouraged to call 1-800-257-232.
Quantity in commerce: 127 Units
Distribution: 127 units were distributed in Australia to 32 Consignees.
Product codes and lots: Begins with Lot Number CMA or CMB Product Code LSM0800626 Product Code LSM1350626 Product Code LSM0800637 Product Code LSM1350637 Product Code LSM0800726 Product Code LSM1350726

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0718-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0718-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-25	2019-12-19

Product code PRL

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)