NA 2C6218Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00085412003863), received between Oct 16, 2018 and Dec 3, 2024 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K130245); they may or may not involve this specific model.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2024Backflow; Fracture; Backflow; Fracture

  IT WAS REPORTED THE STOP COCK JOINT OF A THREE GANG LARGE BORE STOPCOCK MANIFOLD APPEARED CRACKED AND SUBSEQUENTLY THE PATIENT¿S BLOOD PRESSURE (BP) DROPPED. THIRTY SECONDS AFTER TURNING THE PATIENT, THE NURSES OBSERVED THE PATIENT¿S BP DROPPED (VALUES NOT REPORTED). THE NURSE IMMEDIATELY ASSESSED ALL SITES AND NOTED A BACKFLOW OF BLOOD WHERE THE EPINEPHRINE WAS INFUSING. UPON FOLLOWING THE LINE, THE NURSE SAW THE ¿MEDICATION BRIDGE LINE WAS CRACKED IN HALF (THE 3-WAY BRIDGE THAT IS FUSED TOGETHER NOT THE 3 WAY STOP COCKS THAT ARE PIECED TOGETHER)¿. THE NURSE IMMEDIATELY RELOCATED THE INFUSION TO ANOTHER PORT. THE EMERGENCY TEAM WAS CALLED TO PATIENT BEDSIDE AND CALCIUM CHLORIDE STICK WAS ADMINISTERED. PATIENT BLOOD PRESSURE RESPONDED APPROPRIATELY, AND A ¿NEW BRIDGE¿ WAS CREATED FOR MEDICATION. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Low Blood Pressure/ Hypotension

  MAUDE report 20832667 ↗
• InjuryOct 15, 2024Break; Break

  IT WAS REPORTED A THREE GANG LARGE BORE STOPCOCK MANIFOLD BROKE. THE PATIENT HAD A RIGHT SUBCLAVIAN CENTRAL LINE WITH ONE PORT. ALL MEDICATIONS INCLUDING VASOPRESSIN, NOREPINEPHRINE, AND PHENYLEPHRINE WERE ALL ON ONE ¿LONG STOPCOCK¿. THE STOPCOCK SNAPPED AND BROKE OFF. THE PATIENT¿S MEAN ARTERIAL PRESSURE (MAP) DROPPED TO THE 50¿S. THE NURSE REPLACED THE STOPCOCK AND THE PATIENT¿S BLOOD PRESSURE RECOVERED WITHOUT FURTHER INCIDENT. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 20457913 ↗
• MalfunctionSep 23, 2024Backflow; Backflow

  IT WAS REPORTED THAT THE BLOOD BACK FLOWED IN A THREE GANG LARGE BORE STOPCOCK MANIFOLD DURING INFUSION. FURTHER DESCRIBED AS, THE ARTERIAL LINE OF A PATIENT WAS FOUND TO BE BACKING UP WITH BLOOD, DESPITE PROPER POSITIONING OF STOPCOCKS AND TIGHT CONNECTIONS. UPON INSPECTION, IT WAS DISCOVERED THAT THE DRAW PORT VALVE WAS STUCK IN A DEPRESSED POSITION, LEADING TO THE INAPPROPRIATE BACKFLOW OF BLOOD. TUBING WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20279258 ↗
• InjurySep 17, 2024Break; Break

  IT WAS REPORTED A THREE GANG LARGE BORE STOPCOCK MANIFOLD BROKE WHEN TURNING A PATIENT. DURING A NOREPINEPHRINE AND VASOPRESSIN INFUSION, THE PATIENT WAS TURNED, AND THE NURSE NOTED THE PATIENT NEEDED TO HAVE ¿INCREASED VASOPRESSIN REQUIREMENT¿. AFTER THE NURSE INVESTIGATED THE LINES, THE MANIFOLD WAS OBSERVED TO BE BROKEN. THE PATIENT BECAME HYPOTENSIVE WITH SYSTOLIC BLOOD PRESSURE IN THE 80'S; HOWEVER, A NEW MANIFOLD WAS IMMEDIATELY PLACED ON THE CENTRAL LINE, DRIPS WERE RECONNECTED, AND THE BP RECOVERED WITHIN A MINUTE. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 20241600 ↗
• InjurySep 17, 2024Break; Break

  IT WAS REPORTED A THREE GANG LARGE BORE STOPCOCK MANIFOLD BROKE WHEN TURNING A PATIENT. DURING A NOREPINEPHRINE AND VASOPRESSIN INFUSION, THE PATIENT WAS TURNED, AND THE NURSE NOTED THE PATIENT NEEDED TO HAVE "INCREASED VASOPRESSIN REQUIREMENT". AFTER THE NURSE INVESTIGATED THE LINES, THE MANIFOLD WAS OBSERVED TO BE BROKEN. THE PATIENT BECAME HYPOTENSIVE WITH SYSTOLIC BLOOD PRESSURE IN THE 80'S; HOWEVER, A NEW MANIFOLD WAS IMMEDIATELY PLACED ON THE CENTRAL LINE, DRIPS WERE RECONNECTED, AND THE BP RECOVERED WITHIN A MINUTE. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Low Blood Pressure/ Hypotension; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20241258 ↗
• InjuryJul 3, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THE STOPCOCK MANIFOLD OF A THREE GANG LARGE BORE STOPCOCK MANIFOLD WAS OBSERVED BROKEN. DURING AN UNSPECIFIED MEDICATION INFUSION VIA A HICKMAN CATHETER, THE NURSE WENT TO CHECK THE PATIENT AND OBSERVED A ¿LARGE AMOUNT OF BLOOD WAS ON THE BED¿ (VOLUME OF BLOOD NOT REPORTED). ONE UNIT OF PACKED RED BLOOD CELLS WERE TRANSFUSED TO THE PATIENT. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19664615 ↗
• MalfunctionJul 3, 2024Backflow; Crack; Fluid/Blood Leak; Backflow; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT A THREE GANG LARGE BORE STOPCOCK MANIFOLD BROKE DURING PATIENT INFUSION AND LED TO BLOOD BACKFLOWING. THE CRACK/LEAK APPEARS TO HAVE ORIGINATED AT THE CONNECTION SITE. PATIENT WAS CONNECTED WITH ¿IMPELLA¿ AND SWAN GANZ CATHETER. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19662868 ↗
• InjuryOct 16, 2018Disconnection; Detachment of Device or Device Component; Disconnection; Detachment of Device or Device Component

  IT WAS REPORTED A PATIENT EXPERIENCED SIGNIFICANT BLOOD LOSS LEADING TO A NEAR FATAL ARREST AFTER A SEPARATION/ DISCONNECTION OF A THREE GANG LARGE BORE STOPCOCK MANIFOLD OCCURRED WHILE IN USE. THE DEVICE BECAME SEPARATED/ DISCONNECTED AT "THE POINTS WHERE THE STOPCOCKS ARE FUSED". THE DEVICE WAS IN USE WITH AN UNREPORTED MEDICATION. THE CAUSE OF THE SEPARATION WAS NOT REPORTED. IT WAS REPORTED AFTER THE SEPARATION OCCURRED, THE PATIENT SUBSEQUENTLY EXSANGUINATED AND ¿ARRESTED¿ (NO FURTHER DETAILS). TREATMENT AND INTERVENTIONS FOR THE EVENTS WERE NOT REPORTED. AT THE TIME OF THIS REPORT THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Cardiac Arrest; Exsanguination

  MAUDE report 7970790 ↗
• MalfunctionOct 16, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A THREE GANG LARGE BORE STOPCOCKMANIFOLD PRESENTED WITH SOME SEPARATION AROUND THE POINTS WHERE THE STOPCOCKS WERE FUSED. THIS WAS NOTICED BEFORE USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7969522 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130245. One submission often covers many models, so check the product and lot details in each record.

• Z-0189-2026 · Aug 29, 2025 · Open, Classified
  CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set with two CLEARLINK Luer Activated Valve, Pfoduct code