Recall Z-1532-2021
Medtronic Inc. · initiated March 16, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
Codes / lots: UDI 00643169796348, Lot Number B086915
Reason for recall
Incorrect size printed on the device; packaging is labeled correctly.
FDA-determined cause: Process control
Action taken
Beginning 16-Mar-2021, Medtronic initiated verbal communications to consignees in possession of affected units. Consignees were advised to quarantine all affected units within their possession, pending retrieval. A written Medical Device Correction letter was mailed on 03/30/2021 via UPS 2-day delivery to consignees who have received affected product according to Medtronic records. Consignees will be asked to complete and return a confirmation certificate, confirming they have received the notification. Consignees are also asked to return all unused, affected product within their possession.
Details
- Recall number
- Z-1532-2021
- Initiated
- March 16, 2021
- Terminated
- April 15, 2024
- Product code
- QAN – Stent, Iliac Vein
- Quantity
- 23 devices
- Distribution
- US Nationwide distribution in the states of NC, CO, CA, AZ, MT, MO.
- Recalling firm
- Medtronic Inc., Plymouth, MN