Recall Z-1564-2021— Medtronic Inc.
Class III · Ongoing
Class III FDA medical device recall by Medtronic Inc., initiated 2021-03-23. FDA's recall record names no specific 510(k) clearance for this event. Product: VenaSeal Closure System. Reason: Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter..
- Recalling firm
- Medtronic Inc.
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2021-03-23
- Firm location
- Plymouth, MN, United States
Product description
VenaSeal Closure System
Reason for recall
Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter.
Data sourced from openFDA. This site is unofficial and independent of the FDA.