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 fistulas. The macerating mechanism is done by 9 mm basket (made up of four stranded stainless steel wires) that rotates at 3000 rpm when rotator is activated. The current device is 7 Fr in size and comes in two lengths -- 65 cm and 120 cm. This device is used by inserting the catheter into the occluded graft or fistula via introducer sheath and then activating the rotator unit.
FDA Recall Z-0842-05 · Posted 2005-05-13
Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeDXE
Date Initiated2005-03-18
Date Terminated2006-11-22
Product Quantity2418 UNITS
Reason for Recall
The orange Pebax lumen located within the catheter basket may separate from the catheter basket sleeve permitting the lumen to become dislodged during use.
Firm Action
The firm began notification of consignees on 3/23/2005 via certified letter.
Root Cause
Other
Distribution Pattern
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, Taiwan, Turkey, United Kingdom. There are no government accounts.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.