COVERA AVSM09060Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00801741106347), received between Jul 16, 2019 and Dec 19, 2025 — classified as 5 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Misfire” (6 reports).

1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST A STENT PLACEMENT PROCEDURE, THE PATIENT ALLEGEDLY HAD CLOT. REPORTEDLY, THE PATIENT WAS TREATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. THE PATIENT IS REPORTED TO BE STABLE NOW.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20289209 ↗
• MalfunctionAug 21, 2024Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT ELEVEN DAYS POST A STENT GRAFT PLACEMENT, THE STENT ALLEGEDLY COMPRESSED. IT WAS FURTHER REPORTED THAT THE STENT WAS ALLEGEDLY FOUND TO BE FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20014230 ↗
• InjuryAug 20, 2024Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY COMPRESSED AFTER IT WAS DEPLOYED. IT WAS FURTHER REPORTED THAT THE FRACTURE WAS NOTED SEVERAL DAYS AFTER DEPLOYMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 20007300 ↗
• MalfunctionJul 25, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE EXPIRED STENT WAS ALLEGEDLY PLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19834507 ↗
• MalfunctionJun 14, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT GRAFT WAS ALLEGEDLY BENT AND STARTED CURVING WHILE DEPLOYING THE STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17123862 ↗
• MalfunctionApr 19, 2023Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY HAD MALFUNCTION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16771167 ↗
• MalfunctionOct 15, 2022Loss of or Failure to Bond; Break; Positioning Failure; Loss of or Failure to Bond; Break; Positioning Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY FAILED TO DEPLOY. IT WAS FURTHER REPORTED THE DEVICE WAS ALLEGEDLY BROKEN. THE PROCEDURE WAS COMPLETED USING SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15612530 ↗
• MalfunctionJul 26, 2022Loss of or Failure to Bond; Positioning Failure; Misfire; Loss of or Failure to Bond; Positioning Failure; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE THROUGH LEFT ARTERIOVENOUS GRAFT, THE STENT ALLEGEDLY FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15101772 ↗
• MalfunctionJul 13, 2022Misfire; Activation Failure; Misfire; Activation Failure

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY PARTIALLY DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14998556 ↗
• InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT THE PATIENT DEVELOPED ADVERSE EVENT OF PULSATILITY THAT WAS POSSIBLY RELATED TO THE STUDY DEVICE. THE ADVERSE EVENT WAS RECOVERED. APPROXIMATELY TWO YEARS SIX MONTHS POST INDEX PROCEDURE, THE PATIENT DEVELOPED 50 % OF TARGET LESION STENOSIS. A STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Stenosis

  MAUDE report 12472908 ↗
• MalfunctionNov 24, 2020Break; Positioning Failure; Misfire; Break; Positioning Failure; Misfire

  IT WAS REPORTED THAT DURING A STENT PLACEMENT IN UPPER ARM, THE STENT WAS ALLEGEDLY FAILURE TO DEPLOY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10893337 ↗
• MalfunctionNov 11, 2020Positioning Failure; Misfire; Positioning Failure; Misfire

  IT WAS REPORTED THAT DURING A VASCULAR STENT GRAFT PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO DEPLOY IN A PORTAL HEPATIC SHUNT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10821929 ↗
• InjuryMar 12, 2020Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL APPROXIMATELY TWO YEARS POST INDEX PROCEDURE, 60% STENOSIS LESION WAS IDENTIFIED AND RE-INTERVENTION WAS PERFORMED TO PULSATILITY USING A STANDARD PTA BALLOON AND FINAL RESIDUAL STENOSIS WAS 10%. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Stenosis

  MAUDE report 9824448 ↗
• InjuryJul 16, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL APPROXIMATELY 4-MONTHS POST INDEX PROCEDURE, TARGET LESION STENOSIS WAS IDENTIFIED. STANDARD PTA WAS PERFORMED WITH SUCCESSFUL RESULT. IT WAS FURTHER REPORTED APPROXIMATELY 9-MONTHS POST INDEX PROCEDURE, TARGET LESION STENOSIS, ACCESS THROMBOSIS, AND DECREASED ACCESS BLOOD FLOW WERE IDENTIFIED. STANDARD PTA, THROMBECTOMY, AND STENT GRAFT WERE USED WITH SUCCESSFUL RESULT. APPROXIMATELY 9-MONTH 24-DAY POST INDEX PROCEDURE, TARGET LESION STENOSIS WAS IDENTIFIED. STANDARD PTA WAS USED TO TREAT THE LESION WITH SUCCESSFUL RESULT. IT WAS FURTHER REPORTED APPROXIMATELY 10-MONTH POST INDEX PROCEDURE, TARGET LESION STENOSIS, DIMINISHED AND ABNORMAL THRILL AND ACCESS THROMBOSIS WERE IDENTIFIED. STANDARD PTA AND THROMBECTOMY WERE USED TO TREAT THE LESION WITH SUCCESSFUL RESULT. APPROXIMATELY 10-MONTH 21-DAY POST INDEX PROCEDURE, TARGET LESION STENOSIS, DIMINISHED AND ABNORMAL THRILL AND ACCESS THROMBOSIS WERE IDENTIFIED. STANDARD PTA, STENT GRAFT AND THROMBECTOMY WERE USED TO TREAT THE LESION WITH SUCCESSFUL RESULT. IT WAS FURTHER REPORTED THAT APPROXIMATELY 11-MONTH POST INDEX PROCEDURE, PATIENT EXPERIENCED 60% TARGET LESION STENOSIS, NU

  Patient problems: Stenosis

  MAUDE report 8795335 ↗