Perclose ProGlide™ 12673-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 10,588 adverse event reports that list this exact device (DI 08717648013089), received between Oct 28, 2015 and Sep 29, 2026 — classified as 13 deaths, 10,261 injuries, 314 malfunctions.

The most frequently reported specific device problem is “Failure to Cycle” (4,088 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 10,588 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Separation

  It was reported that this was closure of an unspecified access site using a ProGlide device using the pre-close technique prior to a Endovascular leak repair interventional procedure. Reportedly, a cuff miss "[suture retrieval issue]" occurred with three ProGlide devices. The sutures of two new ProGlide devices were successfully pre-placed. The Endovascular leak repair procedure was completed. Post procedure during knot advancement, one of the pre-placed sutures snapped/separated. It is unknown which of the two pre-placed sutures snapped. The remaining suture/knot was advanced to the vessel and tightened as intended. Manual compression was applied to achieve hemostasis. There was no reported adverse patient effect. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935351 ↗
• MalfunctionSep 29, 2026Improper or Incorrect Procedure or Method; Malposition of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932508 ↗
• MalfunctionSep 28, 2026Difficult to Remove; Failure to Advance

  From Staff: Unable to advance Proglide in or out of Right Femoral artery. Patient brought to the operating room. patient was here for heart Cath - unable to do heart Cath through the radial artery due to tortuosity so we switched to femoral approach. Unable to determine the reason why this happened.From Operative Report: At the end of the procedure, Perclose ProGlide device was used to close the arteriotomy. During device deployment, device foot plate was stuck in the subcutaneous tissue and was unable to be retrieved with manual traction. Manual pressure was immediately held over the right groin and Vascular surgery assessed the patient and recommended taking patient to the Operating Room emergently for surgical cutdown, device retrieval and closure of arteriotomy.

  Patient problems: Foreign Body In Patient

  MAUDE report 50913336 ↗
• MalfunctionSep 24, 2026Material Separation; Improper or Incorrect Procedure or Method

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885679 ↗
• MalfunctionSep 22, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859322 ↗
• MalfunctionSep 22, 2026Difficult to Open or Close

  It was reported that this was an arteriotomy closure of the calcified right common femoral artery using the pre-close technique via an 8F sheath hole prior to an endovascular aneurysm repair (EVAR) procedure. Reportedly, with 4 ProGlide devices, the footplates would not close. After removal of the devices, the sheath was upsized to a16F, and the EVAR procedure was completed. Hemostasis was achieved via cutdown. There were no reported adverse patient effects. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859321 ↗
• MalfunctionSep 22, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859254 ↗
• MalfunctionSep 22, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859151 ↗
• MalfunctionSep 14, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50760261 ↗
• MalfunctionSep 14, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50760258 ↗
• MalfunctionSep 9, 2026Failure to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50693485 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this was an arteriotomy closure of the calcified left common femoral artery using three ProGlide devices after a revascularization of the right lower extremity procedure using a 6F sheath. Reportedly, a cuff miss "[suture retrieval issue]" occurred with the first ProGlide device. A second ProGlide device was attempted; however, it did not have adequate blood marker from the marker lumen (the device was flushed before insertion and re-flushed out of the body when marker was insufficient). An 8F sheath was inserted and repeat femoral angiogram completed, no abnormalities noted. A third ProGlide device successfully deployed and hemostasis was achieved. The patient was taken to recovery for usual post-op care. The patient was transferred to the hospital after 2.5 hours of recovery. During that recovery period, patient reported nausea and ¿not feeling well¿. The patient was treated for a vagal reaction (hypotension and bradycardia) with 1,100ml normal saline and 0.5mg Atropine. Vital signs returned to normal limits, nausea was relieved. The patient was ambulated at 2.5 hours of recovery and the patient's nausea returned. The left groin was soft, no bleeding, no hema

  Patient problems: Bradycardia; Hematoma; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Nausea

  MAUDE report 50672588 ↗
• InjurySep 4, 2026Device Damaged by Another Device

  It was reported that this was an arteriotomy closure of the right common femoral artery using a ProGlide device using the pre-close technique via an 18F sheath hole prior to a Fenestrated abdominal aortic aneurysm (AAA) repair interventional procedure. The first device was deployed and pre-placed as intended. Reportedly, during use of the second device after deployment, during step 4, the footplate would not retract and was stuck. The lever was stuck and could not be returned to the original position/lowered. A cut-down was performed to remove the device and a guide break held together by the actuator wire was noted. All broken sections of the device were removed. During the cut-down, when the device was removed, it had the first replaced suture stuck on the device along with the second suture. No vessel damage was noted, and no additional devices were used. The sheath size remained an 18F, and the AAA procedure was completed. Hemostasis was achieved with manual compression. There was no reported adverse patient effect. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50614462 ↗
• MalfunctionSep 1, 2026Unintended System Motion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50547824 ↗
• InjuryAug 27, 2026Entrapment of Device; Device Damaged by Another Device; Difficult to Open or Close

  It was reported that this was an arteriotomy closure of the right common femoral artery using a ProGlide device using the pre-close technique via an 18F sheath hole prior to a Fenestrated abdominal aortic aneurysm (AAA) repair interventional procedure. The first device was deployed and pre-placed as intended. Reportedly, during use of the second device after deployment, during step 4, the footplate would not retract and was stuck. The lever was stuck and could not be returned to the original position/lowered. A cut-down was performed to remove the device and a guide break held together by the actuator wire was noted. All broken sections of the device were removed. During the cut-down, when the device was removed, it had the first replaced suture stuck on the device along with the second suture. No vessel damage was noted, and no additional devices were used. The sheath size remained an 18F, and the AAA procedure was completed. Hemostasis was achieved with manual compression. There was no reported adverse patient effect. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50479362 ↗
• InjuryJul 29, 2026Difficult to Open or Close

  It was reported that this was an arteriotomy closure of the right common femoral artery using a ProGlide device using the pre-close technique via a 6F sheath hole prior to a premature ventricular contraction (PVC) ablation interventional procedure. Reportedly, when using the first ProGlide, the footplate didn¿t deploy/open at all. Resistance was noted lifting the lever and had to abandon access and start over. The suture of one new ProGlide device "[second device]" was successfully pre-placed. The sheath was upsized to an 8F, and the PVC procedure was completed. Post procedure, the suture broke "[second device]" during knot advancement and did not provide hemostasis. The suture was then trimmed and removed, and manual compression was applied to achieve hemostasis. There was no reported adverse patient effect. No additional information was provided.

  Patient problems: Hematoma; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50076064 ↗
• MalfunctionJul 27, 2026Material Separation

  It was reported this was a venotomy closure of a right common femoral vein using the pre-close technique via a small-bore sheath prior to a cardiac ablation procedure. The suture of one ProGlide device was successfully pre-placed. The sheath was upsized to and the procedure was completed. Reportedly post procedure, a suture break occurred while advancing the knot. Therefore, a non-Abbott 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 50021317 ↗
• MalfunctionJun 18, 2026Entrapment of Device; Improper or Incorrect Procedure or Method; Malposition of Device

  IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF A LEFT COMMON FEMORAL ARTERY USING A PROGLIDE DEVICE IN A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE WITH A SMALL-BORE SHEATH. REPORTEDLY, THE KNOT WAS DEPLOYED OVER THE WIRE AND ENTRAPPED THE WIRE DURING THE PROCESS. THE SUTURE AND DEVICE ALSO BECAME TANGLED. THE KNOT WAS LOCATED ABOVE THE SKIN; THEREFORE, THE PHYSICIAN WAS ADVISED TO CUT AND REMOVE THE SUTURE. ONCE THE SUTURE WAS REMOVED, THE DEVICE WAS FREED AND WAS REMOVED SAFELY UNDER GUIDANCE. WIRE ACCESS WAS MAINTAINED, AND ANOTHER PERCLOSE DEVICE 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 25555381 ↗
• InjuryJun 18, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT BILATERAL SUTURE PLACEMENT IN THE RIGHT AND LEFT COMMON FEMORAL ARTERIES (RCFA AND LCFA) WITH FOUR PROGLIDE DEVICES (THREE IN THE RCFA AND ONE IN THE LCFA) USING THE PRE-CLOSE TECHNIQUE PRIOR TO TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) INTERVENTIONAL PROCEDURE. REPORTEDLY, THREE PROGLIDE DEVICES WERE PLACED IN THE RCFA; HOWEVER, TWO OF THE THREE PROGLIDE DEVICES FAILED. THE TAVR PROCEDURE WAS COMPLETED. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS FOR 20 MINUTES; HOWEVER, RIGHT LEG AND FOOT PULSES WERE ABSENT/OCCLUDED. THE METHOD USED TO TREAT THE OCCLUSION WAS NOT PROVIDED. ADDITIONALLY, ONE PROGLIDE DEVICE WAS PLACED IN THE LCFA BUT THAT DEVICE ALSO FAILED. THE TAVR PROCEDURE WAS COMPLETED. THE METHOD USED TO ACHIEVE HEMOSTASIS WAS NOT PROVIDED. THERE WAS NO ADVERSE PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 25546756 ↗
• MalfunctionJun 3, 2026Malposition of Device

  IT WAS REPORTED THAT THIS WAS A VENOTOMY CLOSURE OF A RIGHT COMMON FEMORAL VEIN USING A PROGLIDE DEVICE AFTER AN INTERVENTIONAL ABLATION PROCEDURE WITH AN 8F SHEATH. REPORTEDLY, WHEN REMOVING THE PLUNGER, THE SUTURE CONTINUED TO COME OUT OF THE DEVICE AS THERE WAS NO TENSION FELT WHEN PULLING BACK. THE SUTURE WAS MANUALLY CUT AND AN ATTEMPT WAS MADE TO HARVEST THE SUTURE; HOWEVER, THE KNOT WAS UNRAVELED. A NEW PROGLIDE 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 25376929 ↗
• MalfunctionJun 1, 2026Malposition of Device

  IT WAS REPORTED THIS WAS A VENOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL VEIN USING THE PRE-CLOSE TECHNIQUE PRIOR TO A PULSED FIELD ABLATION (PFA) PROCEDURE. THE SUTURE OF A PROGLIDE DEVICE WAS SUCCESSFULLY PLACED. THE SHEATH WAS UPSIZED TO 13F AND THE PFA PROCEDURE WAS COMPLETED. REPORTEDLY POST PROCEDURE, THE KNOT WAS ADVANCED BUT THE SUTURE HAD PARTIALLY CAPTURED THE VESSEL; THEREFORE, HEMOSTASIS WAS NOT ACHIEVED. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THERE WERE NO REPORTED 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 25355067 ↗
• MalfunctionMay 26, 2026Improper or Incorrect Procedure or Method; Malposition of Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THIS WAS AN VENOUS CLOSURE OF THE RIGHT COMMON FEMORAL VEIN USING A PROGLIDE DEVICE USING THE PRE-CLOSE TECHNIQUE VIA A 6F SHEATH HOLE PRIOR TO A ATRIAL SEPTAL DEFECT (ASD) INTERVENTIONAL PROCEDURE. REPORTEDLY, THE DEVICE WAS DEPLOYED PROPERLY BUT THE KNOT AND THE SUTURE LOOP WAS VISIBLE OUTSIDE OF THE TISSUE TRACT, AND THE KNOT LOCKED PREMATURELY, THEREFORE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE KNOT AND REMOVED THE DEVICE. THE KNOT WAS FORMED AND INTACT. THE SUTURE OF ONE NEW PROGLIDE DEVICE WAS SUCCESSFULLY PRE-PLACED. THE SHEATH WAS UPSIZED TO A 14F AND THE ASD PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED PROGLIDE SUTURE AND A FIGURE OF 8 STITCH. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. DURING RETURN DEVICE ANALYSIS, IT WAS NOTED THAT THE RETURNED SUTURE WAS REMOVED FROM THE GUIDE TUBE FOR FURTHER INSPECTION AND WAS ALSO PULLED FROM THE SUTURE BEARING WITH NO ANOMALIES NOTED. IT APPEARS TWO SUTURES WERE RETURNED IN THE LOOPS. BOTH SUTURES WERE CUT APPROXIMATELY 10 INCHES FROM THE KNOT AND WERE NOT SCRATCHED NOR TORN. THE TOTAL LENGTH OF BOTH SUTURES WAS APPROXIMATELY 19 INCHES IN LENGTH. AN ADDITIONAL COMPLAINT (CN-370534) WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25285245 ↗
• MalfunctionMay 26, 2026Improper or Incorrect Procedure or Method; Failure to Advance; Malposition of Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THIS WAS AN VENOUS CLOSURE OF THE RIGHT COMMON FEMORAL VEIN USING A PROGLIDE DEVICE USING THE PRE-CLOSE TECHNIQUE VIA A 6F SHEATH HOLE PRIOR TO AN ATRIAL SEPTAL DEFECT (ASD) INTERVENTIONAL PROCEDURE. REPORTEDLY, THE DEVICE WAS DEPLOYED PROPERLY BUT THE KNOT AND THE SUTURE LOOP WAS VISIBLE OUTSIDE OF THE TISSUE TRACT, AND THE KNOT LOCKED PREMATURELY, THEREFORE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE KNOT AND REMOVED THE DEVICE. THE KNOT WAS FORMED AND INTACT. THE SUTURE OF ONE NEW PROGLIDE DEVICE WAS SUCCESSFULLY PRE-PLACED. THE SHEATH WAS UPSIZED TO A 14F AND THE ASD PROCEDURE WAS COMPLETED. HEMOSTASIS WAS ACHIEVED WITH THE PRE-PLACED PROGLIDE SUTURE AND A FIGURE OF 8 STITCH. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. DURING RETURN DEVICE ANALYSIS, IT WAS NOTED THAT THE RETURNED SUTURE WAS REMOVED FROM THE GUIDE TUBE FOR FURTHER INSPECTION AND WAS ALSO PULLED FROM THE SUTURE BEARING WITH NO ANOMALIES NOTED. IT APPEARS TWO SUTURES WERE RETURNED IN THE LOOPS. BOTH SUTURES WERE CUT APPROXIMATELY 10 INCHES FROM THE KNOT AND WERE NOT SCRATCHED NOR TORN. THE TOTAL LENGTH OF BOTH SUTURES WAS APPROXIMATELY 19 INCHES IN LENGTH. AN ADDITIONAL COMPLAINT (B)(4) WAS CRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25282506 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THIS WAS AN ARTERIOTOMY CLOSURE OF A LEFT COMMON FEMORAL ARTERY USING A PROGLIDE DEVICE AFTER A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE WITH A 7F SHEATH. REPORTEDLY, A PROGLIDE DEVICE WAS DEPLOYED, BUT BLEEDING STILL OCCURRED. THEREFORE, A STARCLOSE DEVICE WAS INSERTED AND SUCCESSFULLY DEPLOYED. HOWEVER, BLEEDING STILL REMAINED. MANUAL COMPRESSION WAS THEN 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: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25246813 ↗
• MalfunctionMay 19, 2026Malposition of Device

  IT WAS REPORTED THIS WAS A VENOTOMY CLOSURE OF A RIGHT COMMON FEMORAL VEIN USING THE PRE-CLOSE TECHNIQUE VIA A 7F SHEATH HOLE PRIOR TO A DIAGNOSTIC PROCEDURE. REPORTEDLY, ONE PROGLIDE SUTURE WAS SUCCESSFULLY PRE-PLACED. THE SHEATH WAS UPSIZED TO 12F AND THE PROCEDURE WAS COMPLETED. HOWEVER, WHEN PERFORMING SUTURE MANAGEMENT, IT WAS OBSERVED SUTURE HAD ONLY CAPTURED ONE SIDE OF VESSEL WALL AND DIDN'T CLOSE. AN ADDITIONAL PROGLIDE WAS INSERTED AND DEPLOYED, BUT THE SAME ISSUE OCCURRED. AN ADDITIONAL CLOSURE 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: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25219491 ↗