Recall Z-0718-2020 ยท PRL Iliac Covered Stent, Arterial
Bard Peripheral Vascular Inc
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
| Date | Dec 19, 2019 (initiated Feb 18, 2019) |
| Status | Terminated |
| Reason | 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 | 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 enco |
| Quantity | 127 Units |
| Distribution | 127 units were distributed in Australia to 32 Consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.