PERCLOSE 12337-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648013065), received between Dec 8, 2016 and Sep 8, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT ARTERIOTOMY CLOSURE OF A CALCIFIED RIGHT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE AT DEVICE VIA A 5F SHEATH AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE DEVICE DID NOT DEPLOY DUE TO CALCIFICATION; A CUFF MISS WAS NOTED. A PROGLIDE DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PHYSICIAN IS REPORTEDLY TRAINED IN THE USE OF THE PERCLOSE AT AND PROGLIDE DEVICES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6851917 ↗
• InjuryDec 8, 2016Detachment Of Device Component

  IT WAS REPORTED THAT AN ARTERIOTOMY CLOSURE OF THE LEFT COMMON FEMORAL ARTERY WAS ATTEMPTED USING A PERCLOSE AT DEVICE WITH A 6FR SHEATH, AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, WHEN ADVANCING THE KNOT OF THE PERCLOSE A-T DEVICE, THE SUTURE BROKE. A PROGLIDE DEVICE WAS USED AND A CUFF MISS OCCURRED. A NON-ABBOTT DEVICE WAS USED TO ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PHYSICIAN IS REPORTED TO BE IN-TRAINING IN THE USE OF THE PERCLOSE A-T AND THE PROGLIDE DEVICE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE ENTIRE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6156595 ↗