Powerlink System with IntuiTrak Delivery System… recallZ-0594-2010 · Endologix Inc · initiated Nov 25, 2009
Terminated All recalls posted in January 2010
Is my device affected?
- 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.
- If yours is listed, follow the instructions from Endologix Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- 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
This action is being taken because the product has the potential for the polyimide tubing to detach from the inner core due to the bond failure. If this occurs, treatment may be delayed or interrupted. The firm's initial health hazard analysis indicated the event may cause temporary or medically reversible adverse health consequences or an outcome where the probability of serious adverse health
FDA root cause category: Process design
What the company is doing
The recall communication was initiated on 11/25/09 by phone call and followed by recall letter via Fed-Ex Overnight. The recall letter informed the consignees of the reason for recall and products affected. Users were instructed to share this information with physicians that performed the affected procedures at their facility. Endologix informed their consignees that their personnel would retrieve the affected devices and return it to Endologix at no cost and would replace the affected units. Consignees with questions or comments about the notice are directed to (800) 983-2284.
Recall details
- Recall number
- Z-0594-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 25, 2009
- Posted by the FDA
- Jan 11, 2010
- Recalling firm
- Endologix Inc
- Quantity
- 14 UNITS DISTRIBUTED: 3 LOT W09-2967 AND 1 LOT W09-3000 STILL AT CONSIGNEES. 10 UNITS USED.
- Product code
- OAD
- FDA submissions
- P040042
- Distribution
- Recalled devices were distributed to medical centers and hospitals in OR, PA, FL, TX, MI and LA.
Product description
Powerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number 34-34-80LE, LOTS W09-2967 AND W09-3000.
Code information (models, lots, serial numbers)
MODEL NUMBER 34-34-80LE, LOTS W09-2967 AND W09-3000.
Other devices under the same FDA submission
3 devices cleared under P040042 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Safire™ TX 402840Irvine Biomedical, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter8 reports
- Safire™ TX 402841Irvine Biomedical, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 report
- Therapy™ IBI-83371Irvine Biomedical, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 53983).
- Z-0593-2010 · TerminatedPowerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number 34-34-80L, LOTS W09-2966 AND W09-2998.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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