Medtronic Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Medtronic Inc.
Lot Codes / Batch Numbers
UDI 00643169796348, Lot Number B086915
Products Sold
UDI 00643169796348, Lot Number B086915
Medtronic Inc. is recalling Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: i due to Incorrect size printed on the device; packaging is labeled correctly.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect size printed on the device; packaging is labeled correctly.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026