Peel-Away G11564Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002115644), received between Oct 9, 2017 and Oct 7, 2019 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Collapse” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 7, 2019Material Separation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9161764 ↗
• MalfunctionNov 12, 2018Collapse; Material Frayed; Collapse; Material Frayed

  IT WAS REPORTED A PEEL-AWAY DENNY SHEATH INTRODUCER SET WAS USED FOR PLACEMENT OF A PERIPHERALLY INSERTED CENTRAL CATHETER IN THE INNER PORTION OF THE UPPER ARM OF THE PATIENT (NO ANOMALIES/PREVIOUS SCARRING). THE PHYSICIAN ACCESSED THE VESSEL WITH ULTRASOUND GUIDANCE AND SUCCESSFULLY ADVANCED THE WIRE. UPON ATTEMPTING TO ADVANCE THE DENNY SHEATH, THE PRODUCT BUCKLED AND THE TIP OF THE SHEATH WAS FOUND TO HAVE FRAYED. THIS HAPPENED A TOTAL OF FIVE TIMES WITH DIFFERENT DENNY SHEATHS EACH TIME. A SIXTH DENNY SHEATH WAS USED SUCCESSFULLY AND ALTHOUGH PROLONGED, THE PROCEDURE WAS COMPLETED. THIS REPORT RECORDS TWO OF THE FIVE SHEATHS. THE OTHER THREE SHEATHS HAVE DIFFERENT OR UNKNOWN LOT NUMBERS AND ARE RECORDED UNDER MEDWATCH REPORT # 1820334-2018-03343 AND 1820334-2018-03390. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING PATIENT DEMOGRAPHICS AND PRE-EXISTING CONDITIONS HAS BEEN REQUESTED BUT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8061200 ↗
• MalfunctionNov 12, 2018Collapse; Material Frayed; Material Deformation; Collapse; Material Frayed; Material Deformation

  IT WAS REPORTED A PEEL-AWAY DENNY SHEATH INTRODUCER SET WAS USED FOR PLACEMENT OF A PERIPHERALLY INSERTED CENTRAL CATHETER IN THE INNER PORTION OF THE UPPER ARM OF THE PATIENT (NO ANOMALIES/PREVIOUS SCARRING). THE PHYSICIAN ACCESSED THE VESSEL WITH ULTRASOUND GUIDANCE AND SUCCESSFULLY ADVANCED THE WIRE. UPON ATTEMPTING TO ADVANCE THE DENNY SHEATH, THE PRODUCT BUCKLED AND THE TIP OF THE SHEATH WAS FOUND TO HAVE FRAYED. THIS HAPPENED A TOTAL OF FIVE TIMES WITH DIFFERENT DENNY SHEATHS EACH TIME. A SIXTH DENNY SHEATH WAS USED SUCCESSFULLY AND ALTHOUGH PROLONGED, THE PROCEDURE WAS COMPLETED. THIS REPORT RECORDS TWO OF THE FIVE SHEATHS. THE OTHER THREE SHEATHS HAVE DIFFERENT OR UNKNOWN LOT NUMBERS AND ARE RECORDED UNDER MEDWATCH REPORT # 1820334-2018-03343 AND 1820334-2018-03344. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING PATIENT DEMOGRAPHICS AND PRE-EXISTING CONDITIONS HAS BEEN REQUESTED BUT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8061199 ↗
• MalfunctionOct 9, 2017Device Operates Differently Than Expected

  THE .018 WIRES (QUANTITY 2) COULD NOT PASS THRU THE PEEL AWAY SHEATH DURING A PICC LINE INSERTION. IT WAS FURTHER NOTED THAT THE SHAFT OF THE DILATOR WAS ELONGATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME RPN. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THIS PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6930816 ↗