Recall Z-1846-2020 ยท DXE Catheter, Embolectomy
Applied Medical Resources Corp
Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407; A4E02/(01)00607915113414; A4E03/(01)00607915113421; A4E04/(01)00607915113438; A4E05/(01)00607915113445; A4E06/(01)00607915113452; A4E08/(01)00607915113476; A4E09/(01)00607915113483
| Date | May 7, 2020 (initiated Oct 24, 2019) |
| Status | Terminated |
| Reason | The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter. |
| Root cause | Component change control |
| Action | On November 08, 2019, a "Urgent: Medical Device Recall" letter was sent via UPS to all affected customers. In addition to providing information on the recalled products, the letter asked customers to do the following: 1. Check your inventory for the recalled product. 2. Complete the Recall Notification Confirmation Form to acknowledge the recall and indicate if your facility is returning or has already used product from the lot listed above. 3. If no product is being returned, please indicate on the Recall Notification Confirmation Form. 4. If you are a distributor, please notify any fac |
| Quantity | 28,799 catheters in total |
| Distribution | Worldwide distribution - United States: Nationwide OUS: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Netherlands, Poland, Saudi Arabia, South Africa, Spain, Taiwan, United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970762 | DUAL LUMEN EMBOLECTOMY CATHETER Applied Medical Resources, Mar 28, 1997 |