Z-0842-05

The Arrow Trerotola Percutaneous Thrombolytic Device (Product Codes: PT-65709-WC, PT-65709-W, PT-65709-HFWC...

Name: Z-0842-05 The Arrow Trerotola Percutaneous Thrombolytic Device (Product Codes: PT-65709-WC, PT-65709-W, PT-65709-HFWC...
Creator: Arrow International Inc
Published: 2005-03-18
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2005-03-18 / Terminated

FDA source

Arrow International Inc began a recall of 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... on 2005-03-18. The reason FDA records is "The orange Pebax lumen located within the catheter basket may separate from the catheter basket sleeve permitting the lumen to become dislodged during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0842-05
Status: Terminated
Initiated: 2005-03-18
Posted: 2005-05-13
Terminated: 2006-11-22
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: 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.
Product code: DXE Catheter, Embolectomy
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.
FDA root cause: Other
Action: The firm began notification of consignees on 3/23/2005 via certified letter.
Quantity in commerce: 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, Taiwan, Turkey, United Kingdom. There are no government accounts.
Product codes and lots: All units with Lot Numbers beginning with: MF311; MF312; MF401; MF402; MF403; MF404; MF405; MF406; MF407; MF408; MF409; MF410; MF411; MF412; MF501.

Product code DXE

K011056Class IIArrow-Trerotola Percutaneous Thrombolytic Device or PtdArrow Intl., Inc. / cleared 2001-10-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)