StarClose SERecalls & reported problems across all models

We found 2 models of StarClose SE by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 671 adverse event reports in the FDA's MAUDE database, received between Aug 5, 2016 and Sep 29, 2026 — classified as 601 injuries, 70 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (131 reports).

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

Most reported StarClose SE problems

StarClose SE models

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

• StarClose SE™ 14679-01

  DEVICE, HEMOSTASIS, VASCULAR
  589 reports
• StarClose SE™ 14679-05

  DEVICE, HEMOSTASIS, VASCULAR
  82 reports

Recent StarClose SE adverse event reports

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

• MalfunctionSep 29, 2026Difficult to Remove; Failure to Fire; Mechanical Jam

  It was reported that this was an arteriotomy closure of a left common femoral artery using a StarClose SE device after a diagnostic angiogram procedure with a 5F sheath. Reportedly, the clip did not deploy and the emergency release did not work; however, the device was ultimately able to be removed. Manual compression was applied to achieve hemostasis. There were no reported adverse patient effects. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936933 ↗
• MalfunctionSep 28, 2026Noise, Audible; Firing Problem

  It was reported that this was an arteriotomy closure using a StarClose device after a procedure. Reportedly, after deploying the clip, the flex guide or delivery tube snapped "[audible noise]", forcing the physician to pull the clip out of artery "[clip stuck on distal end of sheath or device when device was withdrawn]". Manual compression was used to achieve hemostasis. There were no reported adverse patient effects. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917956 ↗
• MalfunctionAug 31, 2026Misfire

  It was reported this was an unknown procedure to treat an unspecified vessel. Reportedly, the StarClose clip deployed prematurely. Manual compression was used to achieve hemostasis. There were no adverse patient effects. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50525322 ↗
• MalfunctionMay 12, 2026Mechanical Jam

  IT WAS REPORTED THAT THIS WAS A CLOSURE USING A STARCLOSE SE DEVICE AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, IN STEP 2, THE PLUNGER WOULD NOT GO DOWN. THE METHOD USED TO ACHIEVE HEMOSTASIS WAS NOT PROVIDED. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25152773 ↗
• MalfunctionApr 30, 2026Misfire

  THIS WAS REPORTED AS AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING A STARCLOSE DEVICE WITH A 6F SHEATH AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE CLIP FIRED BEFORE TRIGGER WAS PRESSED. THE CLIP REMAINED AT THE DISTAL END OF THE SHEATH. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25047124 ↗
• MalfunctionMar 25, 2026Malposition of Device; Firing Problem

  IT WAS REPORTED THAT THIS WAS A CLOSURE USING A STARCLOSE SE DEVICE AFTER A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE. REPORTEDLY, THE STARCLOSE DID NOT ATTACH TO VESSEL. DIRECT PRESSURE WAS HELD TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24694429 ↗
• MalfunctionMar 9, 2026Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING A STARCLOSE SE DEVICE AFTER A LEFT HEART CATHETERIZATION PROCEDURE. REPORTEDLY, THE STARCLOSE SE DEVICE WAS USED 10 DAYS AFTER EXPIRATION. THE STARCLOSE SE DEVICE WAS SUCCESSFULLY USED TO ACHIEVE HEMOSTASIS. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24547340 ↗
• MalfunctionFeb 12, 2026Break; Failure to Fire

  IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY USING A STARCLOSE SE DEVICE AFTER A HEMORRHOIDAL ARTERY EMBOLIZATION PROCEDURE. REPORTEDLY, THE TRIGGER BUTTON WAS PRESSED; HOWEVER, THE CLIP DID NOT DEPLOY. THE CLIP WAS NOT IN THE PATIENT ANATOMY OR THE DEVICE. THE CLIP WAS LATER SEEN LOOSE INSIDE THE PACKAGE WITH THE STARCLOSE SE DEVICE WHEN PACKAGING THE DEVICE AFTER THE PROCEDURE. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED. ANALYSIS OF THE RETURNED STARCLOSE SE DEVICE REVEALED DAMAGE NOTED TO THE ONE VESSEL LOCATOR WING AT THE DISTAL END WAS SEPARATED BUT STILL INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24329058 ↗
• MalfunctionDec 17, 2025Product Quality Problem; Failure to Cut; Product Quality Problem; Failure to Cut

  IT WAS REPORTED THAT THIS WAS A CLOSURE OF AN UNSPECIFIED VESSEL USING A STARCLOSE DEVICE AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, WHEN COMPLETING STEP 2, (PUSHING THE PLUNGER TO OPEN THE VESSEL LOCATOR WINGS AND INITIATE THE SHEATH SPLIT), THE ENTIRE SHEATH SPLIT AND SEEMED LIKE IT WAS WARPED. THEREFORE, THE CLIP WAS NOT DEPLOYED. THE METHOD OF ACHIEVING HEMOSTASIS WAS NOT REPORTED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829934 ↗
• MalfunctionDec 17, 2025Product Quality Problem; Failure to Cut; Product Quality Problem; Failure to Cut

  IT WAS REPORTED THAT THIS WAS A CLOSURE OF AN UNSPECIFIED VESSEL USING A STARCLOSE DEVICE AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, WHEN COMPLETING STEP 2, (PUSHING THE PLUNGER TO OPEN THE VESSEL LOCATOR WINGS AND INITIATE THE SHEATH SPLIT), THE ENTIRE SHEATH SPLIT AND SEEMED LIKE IT WAS WARPED. THEREFORE, THE CLIP WAS NOT DEPLOYED. THE METHOD OF ACHIEVING HEMOSTASIS WAS NOT REPORTED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829726 ↗
• MalfunctionDec 12, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF A MILDLY CALCIFIED LEFT COMMON FEMORAL ARTERY USING A STARCLOSE DEVICE AFTER AN INTERVENTIONAL PERIPHERAL PROCEDURE WITH A 6F SHEATH. REPORTEDLY WHEN ATTEMPTING TO DEPLOY THE STARCLOSE DEVICE, THE SHEATH WAS UNABLE TO SPLIT WHEN PERFORMING STEP 2. A NEW STARCLOSE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23791311 ↗
• MalfunctionDec 11, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF A COMMON FEMORAL ARTERY USING A STARCLOSE SE DEVICE AFTER A NEURO INTERVENTION PROCEDURE, USING A 6F SHEATH. REPORTEDLY, THE SHEATH SPLIT CROOKED DURING STEP 2 (SHEATH SPLIT INITIATION). THEREFORE, THE CLIP WAS NOT DEPLOYED. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23783552 ↗
• MalfunctionDec 9, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF A CALCIFIED RIGHT COMMON FEMORAL ARTERY USING A STARCLOSE DEVICE AFTER A DIAGNOSTIC PROCEDURE WITH A 6F SHEATH. REPORTEDLY, THE STARCLOSE SE DID NOT DEPLOY CORRECTLY. COMPUTED TOMOGRAPHY WAS PERFORMED AND IT WAS FOUND THAT THE CLIP HAD DEPLOYED INSIDE THE POSTERIOR WALL. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23761079 ↗
• MalfunctionNov 24, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THIS WAS AN ARTERIOTOMY CLOSURE OF A RIGHT COMMON FEMORAL ARTERY USING A PROSTYLE DEVICE AFTER AN INTERVENTIONAL PROCEDURE WITH A 6F SHEATH. REPORTEDLY, DUE TO SCAR TISSUE, THE STARCLOSE DID NOT TAKE TO THE VESSEL WALL. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23638615 ↗
• MalfunctionNov 20, 2025Off-Label Use; Mechanical Jam; Off-Label Use; Mechanical Jam

  IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE MILDLY CALCIFIED RIGHT COMMON FEMORAL ARTERY USING A STARCLOSE SE DEVICE AFTER A LEFT SUPERFICIAL FEMORAL ARTERY INTERVENTIONAL PROCEDURE USING A 6F SHEATH. SCAR TISSUE WAS PRESENT AT THE ACCESS SITE. REPORTEDLY, RESISTANCE WAS MET DURING THUMB ADVANCEMENT IN STEP 3 AND AT THE SAME TIME THE WHOLE STARCLOSE DEVICE POPPED OUT OF THE VESSEL; HOWEVER, THE VESSEL LOCATOR WINGS REMAINED OPENED WITH THE PLUNGER WAS STILL ENGAGED. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23607651 ↗

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