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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Abre Venous Selfexpanding Sent System

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 Class 2 Device Recall Medtronic Abre Venous Selfexpanding Sent Systemsee related information
Date Initiated by FirmMarch 16, 2021
Create DateMay 05, 2021
Recall Status1 Terminated 3 on April 15, 2024
Recall NumberZ-1532-2021
Recall Event ID 87638
PMA NumberP200026 
Product Classification Stent, iliac vein - Product Code QAN
ProductMedtronic 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.
Code Information UDI 00643169796348, Lot Number B086915
Recalling Firm/
Manufacturer		 Medtronic Inc.
4600 Nathan Ln N
Plymouth MN 55442-2890
For Additional Information ContactMedtronic Customer Service
800-854-3570
Manufacturer Reason
for Recall		Incorrect size printed on the device; packaging is labeled correctly.
FDA Determined
Cause 2		Process control
ActionBeginning 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.
Quantity in Commerce23 devices
DistributionUS Nationwide distribution in the states of NC, CO, CA, AZ, MT, MO.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA DatabasePMAs with Product Code = QAN
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