Performer G27022Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002270220), received between Feb 28, 2018 and Sep 11, 2020 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 16, 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.

• MalfunctionSep 11, 2020Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, A PERFORMER INTRODUCER LEAKED BETWEEN THE HUB AND SHEATH. BLOOD LOSS WAS REPORTED; HOWEVER, IT IS UNKNOWN IF ANY INTERVENTION WAS REQUIRED TO TREAT BLOOD LOSS. NO ADDITIONAL PROCEDURES WERE REQUIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10520557 ↗
• MalfunctionSep 9, 2020Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: Blood Loss; No Known Impact Or Consequence To Patient

  MAUDE report 10508079 ↗
• InjuryMar 14, 2018Material Separation; Material Separation

  PER USER FACILITY VOLUNTARY MEDWATCH 5200980000-2018-8001, "WHILE PERFORMING A RIGHT POPLITEAL AND TIBIAL ARTERY ANGIOPLASTY, THE COOK 4 FR SHEATH [PERFORMER INTRODUCER] CAME APART AT THE HUB IN THE PATIENT'S ARTERY. MULTIPLE ATTEMPTS TO RETRIEVE THE SHEATH WERE MADE WHILE STAYING ENDOVASCULAR. SURGEONS NEEDED TO CUT DOWN ON PATIENT'S LEG TO OPEN ARTERY AND RETRIEVE THE SHEATH. PATIENT HAD TO BE CONVERTED FROM MONITORED ANESTHESIA CARE (MAC) TO GENERAL ANESTHESIA." ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Code Available

  MAUDE report 7338442 ↗
• InjuryFeb 28, 2018Difficult to Remove; Material Separation

  WHILE PERFORMING A RIGHT POPLITEAL AND TIBIAL ARTERY ANGIOPLASTY, THE COOK 4FR SHEATH CAME APART AT THE HUB IN THE PT'S ARTERY. MULTIPLE ATTEMPTS TO RETRIEVE THE SHEATH WERE MADE WHILE STAYING ENDOVASCULAR. SURGEONS NEEDED TO CUT DOWN ON PT'S LEG TO OPEN ARTERY AND RETRIEVE THE SHEATH. PT HAD TO BE CONVERTED FROM MONITORED ANESTHESIA CARE (MAC) TO GENERAL ANESTHESIA. PLEASE DESCRIBE THE OTHER PRODUCTS AND EQUIPMENT USED DURING THE PROCEDURE (ENDOSCOPE TYPE AND MODEL, INTRODUCER, WIRE GUIDE, ETC.): CATH. PD, VIATRAC 4MM X 30MM X 135CM. CATHETER BALLOON 4 X 80 X 150 ARMADA 18. CATHETER BALLOON 2 X 200 X 150 ARMADA 19. CATHETER BALLOON 6 X 20 X 150 ARMADA 18. CATHETER BALLOON 6 X 80 X 150 ARMADA 18. CATHETER BALLOON ARMADA 14 2.0MM/200MM ON 150CM. CATHETER BALLOON ARMADA 14 2.5MM/120MM ON 150CM. CATHETER BALLOON ARMADA 14 2.5MM/200MM ON 150CM. CATHETER BALLOON ARMADA 14 2.5MM/40MM ON 150CM. CATHETER BALLOON ARMADA 14 2.5MM/80MM ON 150CM. CATHETER BALLOON ARMADA 14 3.0MM/200MM ON 150CM. CATHETER PERIPHERAL DILATATION VIATRAC 14 PLUS 4 MM X 20 MM / 135 CM. CATHETER PERIPHERAL DILATATION VIATRAC 14 PLUS 4 MM X 40 MM / 135 CM. CATHETER SUPPORT NAVICROSS 4FR 135CM STRAIGHT. CATHETER SUPPOR

  Patient problems: Tissue Damage

  MAUDE report 7302263 ↗