Medtronic Recalls PowerCross .018 OTW PTA Dilatation Catheters
Medtronic is recalling 315 units of the PowerCross .018 OTW PTA Dilatation Catheter due to a manufacturing defect causing the balloon to fail to inflate or deflate properly.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect that could lead to treatment failure or injury, but the source text explicitly states no illnesses or injuries have been reported, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Inc. is recalling 315 units of the ev3 PowerCross .018 Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter. The affected devices are sterile, ethylene oxide-sterilized catheters intended to dilate stenoses in various arteries and treat obstructive lesions in arteriovenous dialysis fistulae. The recall covers specific lots distributed in New York, North Carolina, and Washington.
The recall was initiated after an unrelated manufacturing inspection of scrapped products revealed an out-of-specification condition. The catheter outer shafts were found to be pinched and deformed at the proximal balloon bond. Bench testing confirmed that this defect results in the inability to inflate the device, slow deflation, or the inability to deflate the device after expansion.
No illnesses or injuries have been reported in connection with this recall. Healthcare providers and patients should stop using the affected devices and contact Medtronic for instructions on returning or replacing them.
The recalled product
- Product
- 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
- Manufacturer
- Medtronic Inc
- Affected units
- 315
Distribution
Related recalls
Same manufacturer · Medtronic Inc
See all →- HighMedtronic Sphere-9 Catheter may cause ventricular fibrillation with Biotronik ICDs
FDA (Devices) · 2026-05-06
- HighVenous stents recalled over a nitinol anomaly that reduces deployed diameter
FDA (Devices) · 2026-01-21
- ModerateKidney tests recalled for distribution without premarket approval or clearance
FDA (Devices) · 2025-12-10
- HighSmartSync Patient Connector limited the window to abort high voltage therapy
FDA (Devices) · 2025-07-30
- HighCareLink SmartSync limited the window to abort a high voltage therapy
FDA (Devices) · 2025-07-30
Same hazard · device malfunction
See all →- HighPhilips Incisive CT Recalled for Potential Failure to Trigger Clinical Scan
FDA (Devices) · 2026-09-02
- HighBD Needle Kit for Powered Driver Recall Due to Removal Difficulty
FDA (Devices) · 2026-08-26
- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
- HighIntegrated Medcraft Recalls First Aid Kits with Defective Airway Tips
FDA (Devices) · 2026-08-12
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12