COVERARecalls & reported problems across all models

We found 65 models of COVERA by Angiomed GmbH & Co. Medizintechnik KG in the FDA's device registry (GUDID). Together they are named in 292 adverse event reports in the FDA's MAUDE database, received between Nov 26, 2018 and Sep 15, 2026 — classified as 2 deaths, 141 injuries, 149 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (58 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

COVERA recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Dec 22, 2022Open, Classified

   An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding.

   Z-1108-2023 · Root cause: Unknown/Undetermined by firm · names 63 of these models · Recall details · FDA record ↗

Most reported COVERA problems

COVERA models

65 models, most reported first. Each model has its own page with its reports, recalls and device details.

• COVERA AVSM10060

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall33 reports
• COVERA AVSM08060

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall21 reports
• COVERA AVSM09060

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall18 reports
• COVERA AVSM10080

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall16 reports
• COVERA AVSM10040

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall15 reports
• COVERA AVSM09080

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall1 death14 reports
• COVERA AVFM10060

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall14 reports
• COVERA AVSM10100

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall13 reports
• COVERA AVFM09060

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall12 reports
• COVERA AVSM09100

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall11 reports
• COVERA AVSM08040

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall10 reports
• COVERA AVSM09040

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall10 reports
• COVERA AVFM10080

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall10 reports
• COVERA AVFM08060

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall9 reports
• COVERA AVFM10100

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall9 reports
• COVERA AVSM07080

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall8 reports
• COVERA AVSM08080

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall7 reports
• COVERA AVSM07060

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall6 reports
• COVERA AVSM07100

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall6 reports
• COVERA AVSM08100

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall5 reports
• COVERA AVFM08040

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall5 reports
• COVERA AVFM08080

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall5 reports
• COVERA AVSM07040

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall4 reports
• COVERA AVFM08100

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall4 reports
• COVERA AVSM06060

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall3 reports
• COVERA AVFM10040

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall3 reports
• COVERA AVSM06100

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall2 reports
• COVERA AVFM07060

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall2 reports
• COVERA AVFM09040

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall2 reports
• COVERA AVFM09080

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall2 reports
• COVERA AVSL06060

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall1 death2 reports
• COVERA AVSL09040

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall2 reports
• COVERA AVSM06080

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall1 report
• COVERA AVSM07030

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall1 report
• COVERA AVFM06100

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall1 report
• COVERA AVFM07040

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall1 report
• COVERA AVSL07100

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall1 report
• COVERA AVSL08040

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall1 report
• COVERA AVSL08080

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall1 report
• COVERA AVSM06030

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall0 reports
• COVERA AVSM06040

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall0 reports
• COVERA AVSM08030

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall0 reports
• COVERA AVSM09030

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall0 reports
• COVERA AVSM10030

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall0 reports
• COVERA AVFM06040

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall0 reports
• COVERA AVFM06080

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall0 reports
• COVERA AVFM07080

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall0 reports
• COVERA AVFM07100

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall0 reports
• COVERA AVFM09100

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall0 reports
• COVERA AVSL06040

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall0 reports
• COVERA AVSL06080

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall0 reports
• COVERA AVSL06100

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall0 reports
• COVERA AVSL07040

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall0 reports
• COVERA AVSL07060

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall0 reports
• COVERA AVSL07080

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall0 reports
• COVERA AVSL08060

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall0 reports
• COVERA AVSL08100

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall0 reports
• COVERA AVSL09060

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall0 reports
• COVERA AVSL09080

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall0 reports
• COVERA AVSL09100

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall0 reports
• COVERA AVSL10040

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall0 reports
• COVERA AVSL10080

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall0 reports
• COVERA AVSL10100

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 recall0 reports
• COVERA AVSL10060

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 report
• COVERA AVFL08100

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 report

Recent COVERA adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Material Deformation

  On (b)(6) 2026, a patient underwent a stent placement procedure using a Covera Vascular Covered Stent. It was reported that additional interventions were performed in (b)(6) 2026. During the (b)(6) 2026 procedure, the stent demonstrated evidence of collapse, and balloon angioplasty was performed. On (b)(6) 2026, recurrent collapse of the proximal portion of the stent was observed. The physician performed balloon angioplasty using an 8 × 80 mm Vaccess balloon and subsequently relined the Covera stent with a Wraysody stent. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50769778 ↗
• MalfunctionSep 11, 2026Loss of or Failure to Bond; Break; Positioning Failure

  On (b)(6) 2026, a 53-year-old male patient underwent a stent placement procedure using a Covera Vascular Covered Stent for the treatment of severe stenosis at the juxta-anastomotic region of a left radiocephalic arteriovenous fistula (AVF) via the left radiocephalic access site. During the procedure, it was reported that the stent failed to deploy, as the sheath did not retract when the thumbwheel was rotated. It was further reported that the internal wire did not respond to thumbwheel manipulation. The device was successfully retrieved and different brand of stent used and deployed successfully. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50726391 ↗
• MalfunctionJul 19, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions; Reduced Blood Flow

  MAUDE report 25867847 ↗
• MalfunctionJul 9, 2026Migration or Expulsion of Device

  On b)(6) 2026, a patient underwent a stent placement procedure using a Covera Vascular Covered Stent. During the procedure, while the delivery system was being withdrawn following stent deployment, the stent migrated distally by approximately 6 cm. To secure the migrated stent, an additional stent was deployed. It was further reported that the patient has a functioning shunt and is being closely monitored to assess continued access patency and stent stability. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25762528 ↗
• MalfunctionMar 31, 2026Device Contamination with Chemical or Other Material

  ON (B)(6) 2026, A PATIENT WAS PREPPED FOR A STENT PLACEMENT PROCEDURE USING COVERA VASCULAR COVERED STENT. PRIOR TO THE PROCEDURE DURING OPENING THE BOX AND THE STERILE PACKAGING OF THE STENT GRAFT, A HUMAN HAIR OR UNKNOWN PIECE OF FUZZ OR STRING WAS IDENTIFIED ATTACHED TO THE STENT IN THE STERILE PACKAGING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742740 ↗
• MalfunctionMar 16, 2026Difficult or Delayed Positioning; Malposition of Device

  ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING A COVERA VASCULAR COVERED STENT. IT WAS REPORTED THAT DURING THE PROCEDURE THE STENT WAS ALLEGEDLY FULLY DEPLOYED ALL AT ONCE AFTER ONE TURN OF THE BIG WHEEL, CAUSING INACCURATE PLACEMENT OF THE STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24603011 ↗
• MalfunctionJan 8, 2026Misfire

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING A COVERA STENT. IT WAS REPORTED THAT WHEN THE STENT WAS DEPLOYED, PART OF THE STENT ALLEGEDLY STUCK TO THE PAD AND WOULD NOT FULLY OPEN. THE PROCEDURE WAS COMPLETED USING ANOTHER STENT. THERE WERE NO REPORTED PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24000715 ↗
• MalfunctionDec 19, 2025Material Deformation; Material Deformation

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING COVERA. REPORTEDLY, THE STENT DEFORMED AFTER PLACEMENT IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23847417 ↗
• MalfunctionDec 8, 2025Misfire; Misfire

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING COVERA STENT. IT WAS REPORTED THAT DURING PROCEDURE, THE COVERA STENT WAS NOT DEPLOYED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23741123 ↗
• MalfunctionDec 1, 2025Material Deformation; Material Deformation

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING A COVERA STENT. DURING PROCEDURE, IT WAS ALSO REPORTED THAT THE INNER LINING OF THE EPFTE ALLEGEDLY GOT FOLDED INWARD. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23677810 ↗
• MalfunctionNov 21, 2025Break; Positioning Failure; Misfire; Break; Positioning Failure; Misfire

  ON (B)(6) 2025, A PATENT UNDERWENT A STENT GRAFT PLACEMENT PROCEDURE USING COVERA VASCULAR COVERED STENT IN THE ACCESS SITE OF COMMON FEMORAL ARTERY APPROACH FROM THE CONTRALATERAL SIDE. DURING THE PROCEDURE THE COVERA STENT GRAFT ALLEGEDLY FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23615225 ↗
• MalfunctionNov 17, 2025Misfire; Material Deformation; Material Twisted/Bent; Misfire; Material Deformation; Material Twisted/Bent

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING COVERA VASCULAR STENT FOR THE INDICATION OF STENT PLACEMENT WAS A STENOSIS AT THE BASILIC SWING POINT TO THE AXILLARY VEIN. DURING THE PROCEDURE. IT WAS REPORTED THAT A 8X60MM STENT NARROWED AND THE DISTAL END DID NOT FULLY OPEN. THERE WAS NO ISSUE WITH THE RELEASE OF THE STENT OFF THE SHEATH. EVEN THOUGH THE STENT WAS POST DILATED WITH AN 8MM BALLOON, THE STENT REMAINED COMPRESSED AND DID NOT FULLY OPENED AFTER BALLOON DEFLATION. THE STENT APPEARED TWISTED IN THE VESSEL AND NOT PROPERLY SEATED TO THE VESSEL WALL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23566255 ↗
• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF THE CLINICAL TRIAL THAT APPROXIMATELY ONE YEAR EIGHT MONTHS AND NINETEEN DAYS POST COVERA STENT PLACEMENT PROCEDURE FOR CEPHALIC VEIN STENOSIS, THE SUBJECT UNDERWENT ARTERIOVENOUS ACCESS CIRCUIT RE-INTERVENTION ON THE TARGET LEFT ARM FOR DECREASED ACCESS BLOOD FLOW AND PULSATILITY. IT WAS FURTHER REPORTED THAT A STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS PERFORMED DURING RE-INTERVENTION ON THE TARGET LESION ON CEPHALIC VEIN WITH RESIDUAL STENOSIS OF 15% AND NON-TARGET LESION NOT TREATED AT INDEX PROCEDURE ON THE SUBCLAVIAN VEIN WITH INITIAL STENOSIS OF 29.5% AND FINAL RESIDUAL STENOSIS OF 15%. REPORTEDLY, THE RE-INTERVENTION WAS SUCCESSFUL, AND NO NEW ACCESS WAS CREATED. THE CURRENT STATUS OF THE SUBJECT IS UNKNOWN.

  Patient problems: Restenosis

  MAUDE report 23484118 ↗
• MalfunctionNov 6, 2025Fracture; Fracture

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING COVERA VASCULAR COVERED STENT. REPORTEDLY, THE STENT GOT FRACTURED. THEY HAVE HAD PREVIOUS ISSUES WITH COVERA. THERE ARE NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23484117 ↗
• MalfunctionOct 29, 2025Misfire; Misfire

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING COVERA VASCULAR COVERED STENT FOR THE INDICATION OF VENOUS LIMB PSEUDOANEURYSM IN THE ACCESS SITE OF VENOUS LIMB OF LEFT UPPER ARM ARTERIOVENOUS GRAFT. DURING THE PROCEDURE THE STENT DID NOT DEPLOY. THE STENT SYSTEM WAS REMOVED AND FOUND THAT STENT WAS NOT FULLY DEPLOYED AND WAS STILL ON DEPLOYMENT DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23411934 ↗

Other Angiomed GmbH & Co. Medizintechnik KG products

• Venovo84 models · 428 reports · 3 recalls