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The Arrow Trerotola Percutaneous Thrombolytic Device… recallZ-0842-05 · Arrow International Inc · initiated Mar 18, 2005

Terminated All recalls posted in May 2005

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Arrow International Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: Other

What the company is doing

The firm began notification of consignees on 3/23/2005 via certified letter.

Recall details

Recall number
Z-0842-05
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Mar 18, 2005
Posted by the FDA
May 13, 2005
Recalling firm
Arrow International Inc
Quantity
2418 UNITS
Product code
DXE
FDA submissions
K011056
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 description

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.

Code information (models, lots, serial numbers)

All units with Lot Numbers beginning with: MF311; MF312; MF401; MF402; MF403; MF404; MF405; MF406; MF407; MF408; MF409; MF410; MF411; MF412; MF501.

Other devices under the same FDA submission

11 devices cleared under K011056 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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