Flex Extenders 7-5132Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00709078008405), received between Sep 12, 2024 and Mar 21, 2025 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (11 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 27, 2024Open, Classified

   Due to connector within the circuit flex extender not meeting specifications resulting in a low connection force and as a result, the connector may leak or disconnect and may cause life threating conditions or death.

   Z-0263-2025 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 2028807-2025-00007 FOR THE SECOND REPORT. REFER TO 2028807-2025-00008 FOR THE THIRD REPORT. IT WAS REPORTED, WHEN BEING ATTACHED TO THE ENDOTRACHEAL TUBE (ETT) THE FLEX CONNECTOR DID NOT FIT AND SLID OFF WHILE THE PATIENT WAS ASLEEP, DURING THE SURGERY. THE FLEX CONNECTOR WAS 'STERILELY' REATTACHED TO THE ETT, USING A PIECE OF TAPE; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21665228 ↗
• MalfunctionMar 21, 2025Connection Problem; Connection Problem

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 2028807-2025-00006 FOR THE FIRST REPORT, REFER TO 2028807-2025-00007 FOR THE SECOND REPORT. IT WAS REPORTED, WHEN BEING ATTACHED TO THE ENDOTRACHEAL TUBE (ETT) THE FLEX CONNECTOR DID NOT FIT AND SLID OFF WHILE THE PATIENT WAS ASLEEP, DURING THE SURGERY. THE FLEX CONNECTOR WAS 'STERILELY' REATTACHED TO THE ETT, USING A PIECE OF TAPE; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21665227 ↗
• MalfunctionMar 21, 2025Connection Problem; Connection Problem

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 2028807-2025-00006 FOR THE FIRST REPORT. REFER TO 2028807-2025-00008 FOR THE THIRD REPORT. IT WAS REPORTED, WHEN BEING ATTACHED TO THE ENDOTRACHEAL TUBE (ETT) THE FLEX CONNECTOR DID NOT FIT AND SLID OFF WHILE THE PATIENT WAS ASLEEP, DURING THE SURGERY. THE FLEX CONNECTOR WAS [?] STERILELY' REATTACHED TO THE ETT, USING A PIECE OF TAPE; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21665225 ↗
• MalfunctionOct 3, 2024Connection Problem; Connection Problem

  IT WAS REPORTED, DURING PATIENT TRANSPORT THE FLEX EXTENDER AND AMBU DISCONNECTED FROM THE PATIENT (WITH EVERY BREATH); THERE WAS NO REPORTED INJURY. IT WAS ADDITIONALLY REPORTED, THE CERTIFIED REGISTERED NURSE ANESTHETIST (CRNA) MADE DO [MADE IT WORK] UNTIL THE TRANSPORT WAS COMPLETE; IT ONLY SEEMED TO BE AN ISSUE DURING TRANSPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20363709 ↗
• MalfunctionSep 30, 2024Connection Problem; Connection Problem

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 2028807-2024-00034 FOR THE FIRST REPORT. REFER TO 2028807-2024-00053 FOR THE SECOND REPORT. IT WAS REPORTED, THE FLEX CONNECTOR SEPARATED FROM THE BREATHING CIRCUIT, AS IT HEATED, IN THE MIDDLE OF THE CASE; THEY HAD TO FIND THE CONNECTION ISSUE DURING THE CASE AND REATTACH IT. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334080 ↗
• MalfunctionSep 30, 2024Connection Problem; Connection Problem

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 2028807-2024-00034 FOR THE FIRST REPORT. REFER TO 2028807-2024-00054 FOR THE THIRD REPORT. IT WAS REPORTED, THE FLEX CONNECTOR SEPARATED FROM THE BREATHING CIRCUIT, AS IT HEATED, IN THE MIDDLE OF THE CASE; THEY HAD TO FIND THE CONNECTION ISSUE DURING THE CASE AND REATTACH IT. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334065 ↗
• MalfunctionSep 30, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 2028807-2024-00053 FOR THE SECOND REPORT REFER TO 2028807-2024-00054 FOR THE THIRD REPORT. IT WAS REPORTED, THE FLEX CONNECTOR SEPARATED FROM THE BREATHING CIRCUIT, AS IT HEATED, IN THE MIDDLE OF THE CASE; THEY HAD TO FIND THE CONNECTION ISSUE DURING THE CASE AND REATTACH IT. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334026 ↗
• MalfunctionSep 27, 2024Connection Problem; Connection Problem

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 2028807-2024-00049 FOR THE FIRST REPORT, REFER TO 2028807-2024-00052 FOR THE THIRD REPORT. THE ACCOUNT REPORTED, THE ANESTHESIA DEPARTMENT WAS HAVING ISSUES WITH THE FLEX EXTENDERS COMING APART AT THE SMALL END. ADDITIONAL INFORMATION RECEIVED 13SEP2024 REPORTED, THE ISSUE WAS NOTICED DUE TO LEAK IN THE CIRCUIT (DURING PATIENT USE); IT WAS FOUND THE END CAP WAS NOT HOLDING IN PLACE. IT WAS ADDITIONALLY REPORTED; THE CAP WAS STUCK IN AS SNUG AS POSSIBLE TO RESOLVE THE ISSUE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20327715 ↗
• MalfunctionSep 27, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 2028807-2024-00051 FOR THE SECOND REPORT. REFER TO 2028807-2024-00052 FOR THE THIRD REPORT. THE ACCOUNT REPORTED, THE ANESTHESIA DEPARTMENT WAS HAVING ISSUES WITH THE FLEX EXTENDERS COMING APART AT THE SMALL END. ADDITIONAL INFORMATION RECEIVED 13SEP2024 REPORTED, THE ISSUE WAS NOTICED DUE TO LEAK IN THE CIRCUIT (DURING PATIENT USE); IT WAS FOUND THE END CAP WAS NOT HOLDING IN PLACE. IT WAS ADDITIONALLY REPORTED; THE CAP WAS STUCK IN AS SNUG AS POSSIBLE TO RESOLVE THE ISSUE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20327580 ↗
• MalfunctionSep 27, 2024Connection Problem; Connection Problem

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 2028807-2024-00049 FOR THE FIRST REPORT, REFER TO 2028807-2024-00051 FOR THE SECOND REPORT. THE ACCOUNT REPORTED, THE ANESTHESIA DEPARTMENT WAS HAVING ISSUES WITH THE FLEX EXTENDERS COMING APART AT THE SMALL END. ADDITIONAL INFORMATION RECEIVED 13SEP2024 REPORTED, THE ISSUE WAS NOTICED DUE TO LEAK IN THE CIRCUIT (DURING PATIENT USE); IT WAS FOUND THE END CAP WAS NOT HOLDING IN PLACE. IT WAS ADDITIONALLY REPORTED, THE CAP WAS STUCK IN AS SNUG AS POSSIBLE TO RESOLVE THE ISSUE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20327510 ↗
• MalfunctionSep 20, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 2028807-2024-00047 FOR THE SECOND REPORT. REFER TO 2028807-2024-00048 FOR THE THIRD REPORT . IT WAS REPORTED, THE CLEAR PIECE CAME APART DURING THE PROCEDURE; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20268378 ↗
• MalfunctionSep 20, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 2028807-2024-00035 FOR THE FIRST REPORT. REFER TO 2028807-2024-00047 FOR THE SECOND REPORT . IT WAS REPORTED, THE CLEAR PIECE CAME APART DURING THE PROCEDURE; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20268371 ↗
• MalfunctionSep 20, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 2028807-2024-00035 FOR THE FIRST REPORT. REFER TO 2028807-2024-00048 FOR THE THIRD REPORT. IT WAS REPORTED, THE CLEAR PIECE CAME APART DURING THE PROCEDURE; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20268370 ↗
• MalfunctionSep 18, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 2028807-2024-00033 FOR THE FIRST REPORT. REFER TO 2028807-2024-00039 FOR THE SECOND REPORT. REFER TO 2028807-2024-00040 FOR THE THIRD REPORT. IT WAS REPORTED, THE NEW CLEAR PLASTIC PIECE EASILY CAME OFF OF THE FLEX EXTENDER(S) AND CREATED A DISCONNECT BETWEEN THE PATIENT(S) AND THE VENTILATOR. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED, 21AUG2024 REPORTED, A NONSERIOUS INJURY WAS NOTED WHEN THE FLEX EXTENDER DISCONNECTED DURING MECHANICAL VENTILATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20252007 ↗
• InjurySep 18, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE FIRST OF FOUR REPORTS. REFER TO 2028807-2024-00039 FOR THE SECOND REPORT, REFER TO 2028807-2024-00040 FOR THE THIRD REPORT, REFER TO 2028807-2024-00041 FOR THE FOURTH REPORT. IT WAS REPORTED, THE NEW CLEAR PLASTIC PIECE EASILY CAME OFF OF THE FLEX EXTENDER(S) AND CREATED A DISCONNECT BETWEEN THE PATIENT(S) AND THE VENTILATOR. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED, 21AUG2024 REPORTED, THE FLEX EXTENDER DISCONNECTED DURING OPERATING ROOM (OR) PROCEDURES; HOWEVER, THE DISCONNECTION WAS NOT NOTICED UNTIL THE PATIENT DESATURATED AND WAS SEEN ON THE MONITOR. THE PATIENT'S CURRENT CONDITION WAS NOT PROVIDED; NO ADDITIONAL INFORMATION WAS PROVIDED CONCERNING THE EVENT.

  Patient problems: Low Oxygen Saturation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20251163 ↗
• MalfunctionSep 18, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 2028807-2024-00033 FOR THE FIRST REPORT, REFER TO 2028807-2024-00040 FOR THE THIRD REPORT, REFER TO 2028807-2024-00041 FOR THE FOURTH REPORT. IT WAS REPORTED, THE NEW CLEAR PLASTIC PIECE EASILY CAME OFF OF THE FLEX EXTENDER(S) AND CREATED A DISCONNECT BETWEEN THE PATIENT(S) AND THE VENTILATOR. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED, 21AUG2024 REPORTED, A NONSERIOUS INJURY WAS NOTED WHEN THE FLEX EXTENDER DISCONNECTED DURING AN OPERATING ROOM PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20250695 ↗
• MalfunctionSep 18, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 2028807-2024-00033 FOR THE FIRST REPORT. REFER TO 2028807-2024-00039 FOR THE SECOND REPORT. REFER TO 2028807-2024-00041 FOR THE FOURTH REPORT. IT WAS REPORTED, THE NEW CLEAR PLASTIC PIECE EASILY CAME OFF OF THE FLEX EXTENDER(S) AND CREATED A DISCONNECT BETWEEN THE PATIENT(S) AND THE VENTILATOR. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED, (B)(6) 2024 REPORTED, A NONSERIOUS INJURY WAS NOTED WHEN THE FLEX EXTENDER DISCONNECTED DURING MECHANICAL VENTILATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20250118 ↗
• MalfunctionSep 12, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  SUN MED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. AS NO SPECIFIC PATIENT OR PROCEDURE IDENTIFYING INFORMATION WAS PROVIDED, THIS REPORT WILL DOCUMENT BOTH INCIDENTS. IT WAS REPORTED, THE PRODUCT NOW APPEARS TO COME IN 2 PIECES AND A CLEAR PIECE BECAME DISLOGDGED TWICE (IN THE MIDDLE OF TWO CASES); THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20206989 ↗