ClearanceBrief
Recall Z-1805-2024 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Medtronic Perfusion Systems

Medtronic Venous Cannulae: a) DLP 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120, b) DLP 24 Fr. Malleable Single Stage Venous Cannula, Model Number 68124, c) DLP 28 Fr. Malleable Single Stage Venous Cannula, Model Number 68128, d) DLP 30 Fr. Malleable Single Stage Venous Cannula, Model Number 68130, e) DLP 34 Fr. Malleable Single Stage Venous Cannula, Model Number 68134, f

DateMay 10, 2024 (initiated Mar 19, 2024)
StatusOpen, Classified
ReasonPotential for unsealed sterile packing.
Root causeProcess control
ActionMedtronic issued an Urgent Medical Device Recall notice to its consignees on 03/19/2024 via letter (UPS). The notice explained the issue, potential risk, and requested the consignee identify and return the product. Consignee was directed to forward the notice to all affected parties. For questions, the consignee was directed to contact their Medtronic field representative.
Quantity17221 units
DistributionWorldwide distribution.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K022272MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES)
Medtronic Cardiac Surgical Products, Jan 8, 2003