ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. The PowerCross .018 OTW PTA Dilata...
FDA Device Recall #Z-0892-2017 — Class II — November 10, 2016
Recall Summary
| Recall Number | Z-0892-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 10, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic Inc |
| Location | Minneapolis, MN |
| Product Type | Devices |
| Quantity | 315 |
Product Description
ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. The PowerCross .018 OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
Reason for Recall
Medtronic identified an issue with specific models and lots of the PowerCross .018 Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter. During an unrelated manufacturing inspection of scrapped products, an out of specification condition was observed. The catheter outer shafts were pinched and deformed at the proximal balloon bond. Bench testing of affected devices showed that this resulted in either the inability to inflate the device, a slow deflation, or the inability to deflate the device post expansion.
Distribution Pattern
NY, NC, WA
Lot / Code Information
UDI/Product Lot/Serial Product Number UPN/GTIN Number 00821684046647 A358626 AB18W030100150 00821684046883 A357386 AB18W060100150 00821684046722 A357070 AB18W040100150 00821684046777 A358043 AB18W050040150 00821684046722 A356360 AB18W040100150 00821684046777 A357348 AB18W050040150 00821684046562 A359219 AB18W025040150
Other Recalls from Medtronic Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1098-2026 | Class II | Abre Venous Self-Expanding Stent System, Model ... | Dec 4, 2025 |
| Z-0321-2024 | Class II | Medtronic Mo.Ma Ultra Proximal Cerebral Protect... | Oct 12, 2023 |
| Z-0322-2024 | Class II | Medtronic Mo.Ma Ultra Proximal Cerebral Protect... | Oct 12, 2023 |
| Z-0320-2024 | Class II | Medtronic Mo.Ma Ultra Proximal Cerebral Protect... | Oct 12, 2023 |
| Z-1483-2022 | Class II | Medline Sprinter OTW, Model/Catalog Number SPR2... | Jun 24, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.