PFVClass IIIImplant

System, Endovascular Graft, Arteriovenous (av) Dialysis Access Circuit Stenosis Treatment

Unknown

An endovascular graft for AV dialysis access is a stent graft intended for the revision of arteriovenous access circuits to maintain or re-establish vascular access (treat stenotic lesions or thromboic occlusions) for hemodialysis.

MDR events2,731All time

Recalls1All time

Registered firms22Currently listed

510(k) clearances0All time

Recent MDR events

2,731 adverse event reports on file

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Event type breakdown

Malfunction1,876

Injury824

Death31

Most-reported manufacturers

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Angiomed Gmbh & Co. Medizintechnik Kg1,481 Bard Peripheral Vascular, Inc.501 W.l. Gore & Associates476 W. L. Gore & Associates, Inc.161 Merit Medical Systems Inc.23 Angiomed Gmbh & Co. Medizintechnik Kg -968144220 Merit Medical Systems Inc19 Merit Medical Systems, Inc13

Recalls

1 recall events for this product code

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Bard Peripheral Vascular Inc
Open, ClassifiedFeb 9, 2023
The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework. The inner lumen of th
An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding.
Z-1108-2023 · View FDA record ↗

Registered firms

22 firms currently registered for this product code

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510(k) clearances

0 clearances for this product code

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No 510(k) clearances on file for this product code.

PMA approvals

5 premarket approvals for this product code

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