Perclose™ ProStyle™ 12773-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 18,037 adverse event reports that list this exact device (DI 08717648235184), received between Apr 23, 2021 and Sep 25, 2026 — classified as 8 deaths, 17,538 injuries, 491 malfunctions.

The most frequently reported specific device problem is “Failure to Cycle” (14,046 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, 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 18,037 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Entrapment of Device

  It was reported that this was an arteriotomy closure of the left common femoral artery using a ProStyle device after an interventional thrombectomy procedure with an 8F sheath. Reportedly, strong resistance was encountered during device removal. Due to concern regarding potential complications, the suture was cut and the device was removed. A new ProStyle device was 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 50897528 ↗
• InjurySep 24, 2026Malposition of Device

  It was reported that this was an arteriotomy closure of the right common femoral artery using a ProStyle device after a cerebral infarction thrombectomy procedure using an 8F sheath. Reportedly, the procedure was performed in the usual manner; however, adequate hemostasis could not be achieved. A second ProStyle device was used to achieve hemostasis. Two days after the procedure during hospitalization, echo examination confirmed stenosis of the vessel near the puncture site and a structure resembling suture material within the vessel near the puncture site. The suture captured the back wall of the vessel, likely due to plaque on the back wall. Vascular repair surgery was performed on (b)(6) 2026. There was a reported clinically significant delay in the procedure or therapy. No additional information was provided.

  Patient problems: Stenosis

  MAUDE report 50890342 ↗
• MalfunctionSep 24, 2026Off-Label Use; Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889840 ↗
• MalfunctionSep 24, 2026Material Separation

  It was reported that this was a venotomy closure of a right common femoral vein using a ProStyle device after an interventional atrial fibrillation ablation procedure with an 8F sheath. Reportedly, the suture broke while advancing the knot for all three devices. A new ProStyle device was 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 50883002 ↗
• MalfunctionSep 24, 2026Material Separation

  It was reported that this was a venotomy closure of a right common femoral vein using a ProStyle device after an interventional atrial fibrillation ablation procedure with an 8F sheath. Reportedly, the suture broke while advancing the knot for all three devices. A new ProStyle device was 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 50883001 ↗
• MalfunctionSep 24, 2026Material Separation

  It was reported that this was a venotomy closure of a right common femoral vein using a ProStyle device after an interventional atrial fibrillation ablation procedure with an 8F sheath. Reportedly, the suture broke while advancing the knot for all three devices. A new ProStyle device was 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 50882996 ↗
• MalfunctionSep 24, 2026Material Separation

  It was reported this was an arteriotomy closure of the calcified right common femoral artery using the pre-close technique prior to a transcatheter aortic valve replacement (TAVR) procedure. The sutures of two ProStyle devices were successfully pre-placed. The sheath was upsized to greater than 10F and the TAVR procedure was completed. Reportedly post procedure, one of the blue rail sutures broke when tightening down the suture over the wire using the snare knot pusher. Enough of the rail suture that broke was left to advance the knot successfully and achieve hemostasis with that same suture and the other successfully pre-placed suture. There were no reported adverse patient effects. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876815 ↗
• MalfunctionSep 23, 2026Failure to Cycle; Unintended System Motion; Improper or Incorrect Procedure or Method

  It was reported that this was venous closure of the right common femoral vein using a ProStyle device using the pre-close technique via a 10F sheath hole prior to an ablation interventional procedure. Reportedly, during step 2, the plunger was pulled back/dislodged (protruding) but still in the device. The plunger was then pushed back into the handle/device. The plunger was then depressed, and a cuff miss was noted when the plunger was removed (step3). The suture of one new ProStyle device was successfully pre-placed. The sheath was upsized to a 13F, and the ablation procedure was completed. Hemostasis was achieved with the pre-placed ProStyle suture. There was no reported adverse patient effect. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869951 ↗
• MalfunctionSep 23, 2026Material Separation; Material Split, Cut or Torn

  It was reported that suture placement in the right common femoral artery using a ProStyle device using the pre-close technique via a 6F sheath hole prior to a transcatheter aortic valve replacement (TAVR) interventional procedure. The sutures of two ProStyle devices were successfully placed. The sheath was upsized to a 16F sheath, and the TAVR procedure was completed. Reportedly post procedure, during knot advancement of the second device suture, a frayed suture was noted. The suture break ultimately occurred after the frayed suture while tightening the knot. The first pre-placed suture worked as intended and achieved hemostasis. There was no reported adverse patient effect. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869249 ↗
• MalfunctionSep 23, 2026Difficult to Remove; Physical Resistance/Sticking

  Per the hospital report, the surgeon deployed the device to close a groin access site. The device was stuck in the femoral artery. Due to the inability of removing the device, a cut-down surgical intervention had to be done. The device was intact once retrieved.

  Patient problems: Foreign Body In Patient

  MAUDE report 50867056 ↗
• MalfunctionSep 22, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858401 ↗
• MalfunctionSep 22, 2026Material Separation

  It was reported that this was an arteriotomy closure of the Left common femoral artery using a ProStyle device after a percutaneous coronary intervention using a 6F sheath. Reportedly, a suture break occurred during knot advancement. A new ProStyle device was used to achieve hemostasis. There was no adverse patient effect. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50855211 ↗
• InjurySep 21, 2026Malposition of Device

  It was reported this was an arteriotomy closure of a right common femoral artery using a ProStyle device after a Percutaneous Coronary Intervention (PCI) procedure with a 6F sheath. Reportedly, after deployment of a ProStyle device, the formed knot came out of the anatomy with the device. It was suspected the suture was deployed in the tissue tract. A non-Abbott device was then used to achieve hemostasis. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50845907 ↗
• MalfunctionSep 21, 2026Malposition of Device

  It was reported this was a venotomy closure of a right common femoral vein using a ProStyle device after a cardiac ablation procedure with a small-bore sheath. Reportedly, after deploying the needles, it was observed the suture was caught around the soft tissue of the tissue tract. The knot was visualized in the tissue tract and was unable to move down to the vein. Therefore, the device was removed and replaced with another ProStyle device. However, the same issue occurred. Manual compression was then 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 50842871 ↗
• MalfunctionSep 21, 2026Malposition of Device

  It was reported this was a venotomy closure of a right common femoral vein using a ProStyle device after a cardiac ablation procedure with a small-bore sheath. Reportedly, after deploying the needles, it was observed the suture was caught around the soft tissue of the tissue tract. The knot was visualized in the tissue tract and was unable to move down to the vein. Therefore, the device was removed and replaced with another ProStyle device. However, the same issue occurred. Manual compression was then 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 50842822 ↗
• MalfunctionSep 18, 2026Detachment of Device or Device Component; Activation Problem

  Perclose suture was not attached to needle and could not be deployed. This happened with two separate Perclose devices.Replaced with a third Perclose device that was deployed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50818050 ↗
• InjurySep 16, 2026Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Open or Close

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Vascular Dissection

  MAUDE report 50794769 ↗
• MalfunctionSep 16, 2026Difficult to Remove; Malposition of Device

  It was reported that this was an arteriotomy closure of the calcified right common femoral artery using a ProStyle device after an endovascular treatment procedure using an 8F sheath. Reportedly, after the plunger was depressed and withdrawn the suture was cut and the foot was retracted. The ProStyle device was attempted to be removed; however, the device could not be removed. The ProStyle device was able to be advanced slightly, the foot was repeatedly closed and opened, after which the device was able to be removed successfully. Under normal circumstances, the suture would engage the vessel wall and, once tied, achieve hemostasis; however, for an unknown reason, the suture did not capture the vessel wall and was instead pulled out without securing the tissue. Hemostasis was achieved with a non-Abbott device. There were no reported adverse patient effects. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794437 ↗
• MalfunctionSep 16, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794077 ↗
• MalfunctionSep 16, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794014 ↗
• MalfunctionSep 16, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794008 ↗
• MalfunctionSep 16, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794005 ↗
• MalfunctionSep 16, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791227 ↗
• InjurySep 15, 2026Entrapment of Device

  It was reported that this was closure of an unspecified access site using a ProStyle device after an unknown procedure. Reportedly, the ProStyle was stuck in the vessel which required a second procedure to remove the device. The method used to achieve hemostasis was not provided. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777286 ↗
• InjurySep 14, 2026Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Difficult to Open or Close

  It was reported this was a venotomy closure of the right common femoral vein using the pre-close technique via an 8F sheath hole prior to a pulsed field ablation (PFA) procedure using Volt. The suture of a ProStyle device was successfully placed. The sheath was upsized to 14F and the PFA procedure was completed. Reportedly, during post close, the knot was advanced but there was still significant oozing at the access site; therefore, a second ProStyle device was deployed. The lever was returned to its original position, and the footplate was retracted after the deployment; however, with the device not able to be removed from the access site, it was thought by the physician to have gotten hung up on a valve. The footplate did not retract fully back into device. The ProStyle device was twisted, bent and pulled against resistance in a manner to try and release it from the inside of the vessel, resulting in a crack and separation where the metal meets the plastic at the elbow of the device. Once seen on Angio, the operating room was immediately notified, and the patient was transferred for surgical cutdown. During the cutdown, the ProStyle device was safely removed. Hemostais was achiev

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50763312 ↗