Recall Z-2504-2021 ยท DRA Catheter, Steerable
Medtronic Perfusion Systems
DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
| Date | Aug 24, 2021 |
| Status | Open, Classified |
| Reason | Potential for a wire protrusion through the left heart vent catheter tip |
| Root cause | Process control |
| Action | On about 08/24/2021, Medtronic notified customers via 2-day tracked mail letter titled, "URGENT MEDICAL DEVICE RECALL DLP Left Heart Vent Catheters." The letter instructed customers identify and quarantine all affected DLP Left heart Vent Catheters, return all unused affected product in inventory to Medtronic by contacting Medtronic Customer Service at 1-800-854-3570 and to contact your local Medtronic Representative can assist you in the return of this product, and complete and return the provided Customer Confirmation Form and email to rs.cfqfca@medtronic.com. Additional instructions inclu |
| Quantity | 51,494 units |
| Distribution | Nationwide distribution to AL, CA, CO, DC, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI. International distribution to Albania, Algeria, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, C |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K834352 | ADULT VENT CATHETER Dlp, Inc., Jan 27, 1984 |