Recall Z-0842-05 ยท DXE Catheter, Embolectomy
Arrow International Inc
The Arrow Trerotola Percutaneous Thrombolytic Device (Product Codes: PT-65709-WC, PT-65709-W, PT-65709-HFWC, and PT-12709-WC) consists of a catheter with an expandable fragmentation basket attached to a through lumen torque cable and an outer catheter sheath. The catheter is used in conjunction with a low-speed, battery operated rotator unit to treat thrombosed hemodialysis grafts and AV fistula
| Date | May 13, 2005 (initiated Mar 18, 2005) |
| Status | Terminated |
| Reason | The orange Pebax lumen located within the catheter basket may separate from the catheter basket sleeve permitting the lumen to become dislodged during use. |
| Root cause | Other |
| Action | The firm began notification of consignees on 3/23/2005 via certified letter. |
| Quantity | 2418 UNITS |
| Distribution | Product was distributed nationwide to dealers, hospitals, sales representatives, and subsidiaries (distributors). The product was also distributed to Australia, Canada, Colombia, Czech Republic, France, Germany, Israel, Italy, Japan, Netherlands, Russia, South Africa, South Korea, Spain, Sweden, Ta |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011056 | ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD Arrow Intl., Inc., Oct 24, 2001 |