Recall Z-1914-2015 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Medtronic Perfusion Systems
Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Cannula Replacement Kit, Models 96017 and 96021. Sterilized using Ethylene Oxide. The cannula and dilator components are polyurethane and have tapered proximal tips to aid in diameter transition from the dilator. The dilator components utilize tip indicator bands for minimum tip alignment of the component p
| Date | Jun 26, 2015 (initiated Jun 12, 2015) |
| Status | Terminated |
| Reason | Medtronic is recalling select lots of DLP Femoral Arterial Cannula product due to recent reports in which the user had difficulty or was unable to connect the cannula to the perfusion circuit tubing. |
| Root cause | Nonconforming Material/Component |
| Action | Medtronic sent an Urgent Medical Device Recall letter, dated June 2015 to customers beginning June 12, 2015. The letter identified affected product, described the issue, requested that unused inventory be quarantined and returned to Medtronic. Customers should contact Customer Service at 800-854-3570 and reference RADAR #241958 to initiate a return and credit of product. Additionally a Customer Confirmation Certificate should be completed and faxed to 651-367-0612. |
| Quantity | 1304 devices |
| Distribution | Worldwide Distribution - US Distribution including the states of : AK, AZ, CA, CO, IN, KS, LA, MN, MT, NM, NY, OH, OR, PA, TX, UT, and WI., and to the countries of : Belgium, Brazil, Canada, Colombia, Denmark, France, Germany, Greece, Hungary, India, Ireland, Italy, Korea, Morocco, Netherlands, P |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K875353 | PERCUTANEOUS ARTERIAL/VENOUS CANNULA PLACEMENT KIT Dlp, Inc., Mar 22, 1988 |