EverFlexRecalls & reported problems across all models

We found 41 models of EverFlex by Covidien LP in the FDA's device registry (GUDID). Together they are named in 289 adverse event reports in the FDA's MAUDE database, received between Dec 5, 2016 and Sep 30, 2026 — classified as 1 death, 82 injuries, 206 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (185 reports).

2 FDA recall records 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

EverFlex 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. Jul 14, 2022Open, Classified

   Update to IFU provides a manual deployment workaround method to help mitigate potential harms related to partial stent deployment.

   Z-1644-2022 · Root cause: Other · names 3 of these models · Recall details · FDA record ↗

2. Nov 3, 2017Terminated

   Stent length on the label may not match the length of the stent itself.

   Z-0188-2018 · Root cause: Employee error · names 2 of these models · Recall details · FDA record ↗

Most reported EverFlex problems

EverFlex models

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

• EverFlex™ EVD35-06-150-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 death110 reports
• EverFlex™ EVD35-07-060-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 recall5 reports
• EverFlex™ EVD35-07-120-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 recall5 reports
• EverFlex™ EVD35-07-040-080

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 recall1 report
• EverFlex™ EVD35-07-150-080

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 recall1 report
• EverFlex™ EVD35-06-020-150

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 recall0 reports
• EverFlex™ EVD35-07-150-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  31 reports
• EverFlex™ EVD35-06-150-150

  STENT, SUPERFICIAL FEMORAL ARTERY
  25 reports
• EverFlex™ EVD35-06-120-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  13 reports
• EverFlex™ EVD35-08-150-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  10 reports
• EverFlex™ EVD35-06-080-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  9 reports
• EverFlex™ EVD35-06-100-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  9 reports
• EverFlex™ EVD35-06-040-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  8 reports
• EverFlex™ EVD35-07-150-150

  STENT, SUPERFICIAL FEMORAL ARTERY
  7 reports
• EverFlex™ EVD35-08-040-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  5 reports
• EverFlex™ EVD35-07-060-150

  STENT, SUPERFICIAL FEMORAL ARTERY
  5 reports
• EverFlex™ EVD35-08-040-080

  STENT, SUPERFICIAL FEMORAL ARTERY
  4 reports
• EverFlex™ EVD35-06-060-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  4 reports
• EverFlex™ EVD35-08-080-080

  STENT, SUPERFICIAL FEMORAL ARTERY
  3 reports
• EverFlex™ EVD35-07-080-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  3 reports
• EverFlex™ EVD35-06-120-150

  STENT, SUPERFICIAL FEMORAL ARTERY
  3 reports
• EverFlex™ EVD35-06-150-080

  STENT, SUPERFICIAL FEMORAL ARTERY
  2 reports
• EverFlex™ EVD35-08-020-080

  STENT, SUPERFICIAL FEMORAL ARTERY
  2 reports
• EverFlex™ EVD35-08-060-080

  STENT, SUPERFICIAL FEMORAL ARTERY
  2 reports
• EverFlex™ EVD35-07-040-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  2 reports
• EverFlex™ EVD35-07-100-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  2 reports
• EverFlex™ EVD35-08-120-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  2 reports
• EverFlex™ EVD35-08-040-150

  STENT, SUPERFICIAL FEMORAL ARTERY
  2 reports
• EverFlex™ EVD35-08-150-150

  STENT, SUPERFICIAL FEMORAL ARTERY
  2 reports
• EverFlex™ EVD35-06-040-080

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 report
• EverFlex™ EVD35-07-060-080

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 report
• EverFlex™ EVD35-07-020-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 report
• EverFlex™ EVD35-08-020-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 report
• EverFlex™ EVD35-08-080-120

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 report
• EverFlex™ EVD35-06-040-150

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 report
• EverFlex™ EVD35-06-060-150

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 report
• EverFlex™ EVD35-06-100-150

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 report
• EverFlex™ EVD35-07-080-150

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 report
• EverFlex™ EVD35-07-100-150

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 report
• EverFlex™ EVD35-07-120-150

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 report
• EverFlex™ EVD35-08-060-150

  STENT, SUPERFICIAL FEMORAL ARTERY
  1 report

Recent EverFlex adverse event reports

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

• InjurySep 30, 2026Fracture; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  It was reported that an EVERFLEX ENTRUST stent was being deployed for treatment of an unknown target lesion in the left proximal superficial femoral artery when, during rollback of the dial, the dial broke off the spool wire. The stent was partially deployed at the target site and appeared fractured in the superficial femoral artery. Attempts were made to remove the stent; however, part of the stent became stuck in the sheath. Open surgical cutdown was required to remove the portion of the stent stuck in the sheath. A portion of the stent remained in the patient.

  Patient problems: Insufficient Information

  MAUDE report 50945001 ↗
• MalfunctionAug 13, 2026Malposition of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50232753 ↗
• MalfunctionAug 13, 2026Activation, Positioning or Separation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50232725 ↗
• InjuryAug 12, 2026Difficult to Remove; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  It was reported that during treatment of critical limb ischemia with rest pain in the left lower extremity, an EVERFLEX ENTRUST 7 x 150 x 120 stent was used to treat a calcified chronic total occlusion in the proximal left superficial femoral artery, with stent placement for dissection. The target vessel diameter was 6 mm, with severe lesion calcification and moderate tortuosity. A hostile aortic bifurcation was reported, with multiple episodes of sheath prolapse during the procedure. The vessel was pre-dilated with a 5 mm x 200 mm Sterling balloon, and the instructions for use were followed without issue. After approximately 6 cm of stent deployment, the thumb wheel became difficult to rotate and subsequently locked. Troubleshooting by opening the delivery-system handle was attempted; however, tremendous resistance was encountered while retracting the silver inner sheath. The entire system was attempted to be removed which stretched the stent from the proximal SFA across the SFA and into the distal EIA.  A femoral cutdown was needed to remove the stent. The EIA and CFA portions were removed but the proximal SFA segment was left behind. This segment was later refined with a covered

  Patient problems: Insufficient Information

  MAUDE report 50219833 ↗
• MalfunctionJul 20, 2026Activation, Positioning or Separation Problem; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25872661 ↗
• MalfunctionJul 7, 2026Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  LIMITED INFORMATION REPORTED THAT THE EVERFLEX ENTRUST STENT DELIVERY SYSTEM BROKE UPON STENT DEPLOYMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25735907 ↗
• MalfunctionJul 2, 2026Premature Activation; Malposition of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PERIPHERAL ARTERY STENTING PROCEDURE USING THE EVERFLEX ENTRUST , THERE WAS DIFFICULTY ADVANCING THE STENT THROUGH THE CATHETER WHILE ATTEMPTING TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LESION IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY. THE VESSEL WAS PRE-DILATED WITH AN EVERCROSS 6 MM X 40 MM DEVICE, AND THE STENT SYSTEM WAS ADVANCED OVER A NITREX .035 400 CM GUIDEWIRE THROUGH A TERUMO 6 FR DESTINATION SHEATH. SEVERE RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT AND EXCESSIVE FORCE WAS USED. THE OUTER SHEATH OF THE STENT CATHETER CRACKED AND SEPARATED FROM THE HANDLE DURING USE IN THE PATIENT. THE STENT PREMATURELY DEPLOYED WITHIN THE DESTINATION SHEATH RATHER THAN IN THE TARGET LOCATION, REMAINED WITHIN THE SHEATH WITHOUT MIGRATION, AND WAS REPORTED TO BE JAMMED AT THE END OF THE SHEATH AS OBSERVED UNDER FLUOROSCOPY. THE SHEATH WAS REMOVED FROM THE PATIENT DUE TO THE EVENT, AND THE DEVICE WAS REPORTED TO HAVE BEEN SAFELY REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 6 MM X 80 MM EVERFLEX DEVICE. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY AND NO HEALTH CONSEQUENCES OR IMPACT. A CUT TO A MEDTRONIC EMPLOYEE WAS REPORTED WHEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25688752 ↗
• MalfunctionJun 4, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT AN EVERFLEX ENTRUST 7X150X120 DEVICE WAS ASSOCIATED WITH AN ALLEGATION OF CATHETER HANDLE SEPARATION, WITH THE TIMING OF THE SEPARATION REPORTED AS UNKNOWN. THE DEVICE WAS NEVER IMPLANTED. THE INSTRUCTIONS FOR USE WERE REPORTED TO HAVE BEEN FOLLOWED WITHOUT ISSUE, AND NO DAMAGE TO THE PACKAGING OR ISSUES REMOVING THE DEVICE FROM THE HOOP/TRAY WERE REPORTED. EMBOLIC PROTECTION WAS NOT USED. NO HEALTH CONSEQUENCES OR IMPACT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25394590 ↗
• MalfunctionMar 25, 2026Activation, Positioning or Separation Problem

  A PHYSICIAN WAS IMPLANTING AN EVERFLEX ENTRUST FOR TREATMENT OF A 300MM CALCIFIED PLAQUE LESION IN THE PROXIMAL/MID LEFT SUPERFICIAL FEMORAL ARTERY. THERE WAS SEVERE CALCIFICATION WITH CHRONIC TOTAL OCCLUSION. THE ARTERY WAS 6MM IN DIAMETER. A 6FR NON MEDTRONIC SHEATH AND A NITREX GUIDEWIRE WERE USED. THE VESSEL WAS PRE DILATED AND POST DILATED. NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE DEVICE. IT WAS REPORTED THERE WAS DIFFICULTY NOTED DURING DEPLOYMENT. THE THUMB WHEEL PROGRESSIVELY BECAME HARD TO TURN THEN POPPED AND FREELY TURNED BUT HAD STOPPED DEPLOYMENT. THE PHYSICIAN DISASSEMBLED THE HOUSING AND MANUALLY DEPLOYED STENT. STENT DEPLOYED SUCCESSFULLY WITHOUT INJURY/INTERVENTION. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24685557 ↗
• MalfunctionMar 19, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING TREATMENT OF A PLAQUE LESION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY USING THE EVERFLEX ENTRUST 7X150X120, THERE WAS A ONE-HOUR DELAY IN SURGERY DUE TO PRODUCT MALFUNCTION. CATHETER/HANDLE SEPARATION OCCURRED DURING USE IN THE PATIENT, AND THE DEPLOYMENT WIRE SNAPPED. STENT/STRUTS WERE NOTED TO BE DEFORMED IN VITRO. THE STENT BECAME DEPLOYED INSIDE THE BODY EVEN WHILE THE RED TAB WAS IN PLACE. THE DEVICE COULD NOT BE SAFELY REMOVED AND HAD TO BE DEPLOYED. THE PROCEDURE WAS ABORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24638696 ↗
• MalfunctionMar 11, 2026Malposition of Device

  IT WAS REPORTED THAT DURING TREATMENT OF A CALCIFIED LESION IN THE MID AND DISTAL SEGMENTS OF THE LEFT SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY, THE EVERFLEX ENTRUST 6X150X120 STENT WAS PLACED IN THE INCORRECT ANATOMY, THE STENT UNINTENTIONALLY DEPLOYED OUTSIDE OF THE TARGET SITE. THE STENT DEPLOYED MORE MORE PROXIMALLY THAN INTENDED. THE PROCEDURE WAS SUBSEQUENTLY ABORTED. THE SHEATH USED WAS A NON MEDTRONIC 6/7 FRENCH, AND THE GUIDEWIRE WAS A NON MEDTRONIC 0.014. THE VESSEL WAS PRE-DILATED WITH A TURBOHAWK PLUS LX ATHERECTOMY DEVICE AND A 6X200 IN. PACT ADMIRAL DRUG COATED BALLOON, AND POST-DILATED WITH AN AB35W060150135 DEVICE. THERE WAS NO RESISTANCE ENCOUNTERED DURING DEVICE ADVANCEMENT, AND NO ABNORMALITIES WERE NOTED IN THE ANATOMY OR PACKAGING. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24568693 ↗
• MalfunctionMar 11, 2026Component Missing

  IT WAS REPORTED THAT DURING TREATMENT OF A CALCIFIED LESION IN THE RIGHT DISTAL COMMON ILIAC ARTERY WITH THE EVERFLEX ENTRUST 8X40X120 STENT, THE STENT WAS NOT VISIBLE ON FLUOROSCOPY AND APPEARED TO BE MISSING. THE SYSTEM WAS INSERTED WITH THE RED LOCKING PIN STILL IN PLACE ACCORDING TO INSTRUCTIONS FOR USE, AND THE PHYSICIAN ATTEMPTED STENT DEPLOYMENT WITHOUT VISUALIZATION. MULTIPLE PRIOR STENTS WERE PRESENT IN THE VESSEL, WHICH MADE VISUALIZATION DIFFICULT. FLUOROSCOPY WAS USED TO ATTEMPT VISUALIZATION OF THE STENT. THE VESSEL WAS PRE-DILATED WITH A BOSTON DEVICE, AND THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, AND NO DAMAGE WAS NOTED TO PACKAGING OR DURING REMOVAL FROM THE TRAY. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. ANOTHER IDENTICAL STENT WAS DEPLOYED WITHOUT ISSUE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24566704 ↗
• MalfunctionMar 2, 2026Premature Activation

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A SOFT TISSUE LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY, MID LOCATION, WITH A LESION LENGTH OF 40 MM AND ARTERY DIAMETER OF 6 MM, USING THE EVERFLEX ENTRUST 7X40X80, THERE WAS A DELAY IN SURGERY OF ONE HOUR DUE TO PRODUCT MALFUNCTION. THE STENT WAS DEPLOYED WITHOUT THE THUMB WHEEL BEING USED. THE STENT WAS REMOVED WITHIN THE SHEATH. THE PROCEDURE WAS ABORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24481661 ↗
• InjuryJan 30, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A 150MM CALCIFIED PLAQUE LESION IN THE PATIENT'S PROXIMAL RIGHT SUPERFICIAL FEMORAL ARTERY, THE EVERFLEX ENTRUST 6X150X120 STENT WAS PARTIALLY DEPLOYED AT THE TARGET SITE. NO VESSEL TORTUOSITY REPORTED. ARTERY DIAMETER REPORTED AS 6MM. THE VESSEL WAS PRE-DILATED PRIOR TO STENT PLACEMENT. THE THUMBSCREW/LOCK-PIN WAS CHECKED FOR SECUREMENT PRIOR TO PROCEDURE AND WAS REMOVED PRIOR TO ATTEMPTED DEPLOYMENT. THE PARTIAL DEPLOYMENT RESULTED IN A DELAY IN SURGERY, REQUIRING 45 MINUTES TO REMOVE THE STENT BY SNARING. NO VESSEL DAMAGE REPORTED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24220322 ↗
• MalfunctionJan 29, 2026Difficult to Remove; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT DURING TREATMENT OF A CALCIFIED LESION IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY USING THE EVERFLEX ENTRUST 6X150X120, THERE WAS A 15-MINUTE DELAY IN SURGERY DUE TO PRODUCT MALFUNCTION. THE STENT/STRUTS WERE DEFORMED IN VIVO, AND THE DEPLOYED STENT LENGTH WAS MEASURED AT 175-200 MM. ELONGATION OF THE STENT WAS NOTED. DIFFICULTY WAS NOTED DURING DEPLOYMENT, REQUIRING MANUAL PULLBACK ON THE HANDLE TO DEPLOY THE END OF THE STENT. STENT DEPLOYED SUCCESSFULLY WITHOUT INJURY/INTERVENTION. THE WIRE BECAME STUCK IN THE SYSTEM, NECESSITATING REMOVAL OF THE SYSTEM AS A WHOLE. THE PROCEDURE WAS ABORTED. THE PATIENT HAD A 30% STENOSIS, 150 MM LESION LENGTH, AND 5.5 MM ARTERY DIAMETER, WITH MINIMAL TORTUOSITY AND CALCIFICATION. THE VESSEL WAS PRE-DILATED WITH A 4X150 NANOCROSS AND POST-DILATED WITH A 4X120 NANOCROSS. A 6FR SHEATH AND FMD F-14 FLEX GUIDEWIRE WERE USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209135 ↗

Other Covidien LP products

• Endo GIA48 models · 26,277 reports · 8 recalls
• Endo GIA Ultra3 models · 15,650 reports
• Shiley387 models · 9,392 reports · 5 recalls
• Signia16 models · 8,201 reports · 6 recalls
• LigaSure32 models · 7,283 reports · 1 recall
• Tri-Staple 2.037 models · 4,892 reports · 2 recalls
• Polysorb291 models · 4,564 reports · 2 recalls
• EEA39 models · 4,432 reports · 1 recall