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

FDA device recall Z-0718-2020 · posted 2019-12-19 · Terminated

Recall details

Recalling firm

Bard Peripheral Vascular Inc

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

PRL

Quantity affected

127 Units

Distribution

127 units were distributed in Australia to 32 Consignees.

Date initiated

2019-02-18

Date posted

2019-12-19

Date terminated

2021-04-28

Location

Tempe, AZ