DAR 444SP02012 (UDI 20884522035191)Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 20884522035191), received between May 23, 2024 and Jun 5, 2025 — classified as 50 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (23 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2025Use of Device Problem; Material Split, Cut or Torn; Use of Device Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER THE CUSTOMER OPENED THE PACKAGE AND CONNECTED THE NEGATIVE PRESSURE SUCTION TUBE, THE SUCTION CONTROL VALVE COULD NOT BE PRESSED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND A COMPONENT DAMAGED/TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22154349 ↗
• MalfunctionJun 5, 2025Use of Device Problem; Material Split, Cut or Torn; Use of Device Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER THE CUSTOMER OPENED THE PACKAGE AND CONNECTED THE NEGATIVE PRESSURE SUCTION TUBE, THE SUCTION CONTROL VALVE COULD NOT BE PRESSED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND A COMPONENT DAMAGED/TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22154078 ↗
• MalfunctionMay 14, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER THE CUSTOMER OPENED THE PACKAGE AND CONNECTED THE NEGATIVE PRESSURE SUCTION LINE, THE SUCTION CONTROL VALVE COULD NOT BE PRESSED. THIS ISSUE OCCURRED AT A HOSPITAL AND HAD NOT BEEN OBSERVED DURING PREVIOUS USE. THERE WAS NO PATIENT INVOLVED. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND A COMPONENT DAMAGE/TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22021758 ↗
• MalfunctionMay 14, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER THE CUSTOMER OPENED THE PACKAGE AND CONNECTED THE NEGATIVE PRESSURE SUCTION LINE, THE SUCTION CONTROL VALVE COULD NOT BE PRESSED. THIS ISSUE OCCURRED AT A HOSPITAL AND HAD NOT BEEN OBSERVED DURING PREVIOUS USE. THERE WAS NO PATIENT INVOLVED. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND A COMPONENT DAMAGE/TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22021739 ↗
• MalfunctionMay 14, 2025Use of Device Problem; Material Split, Cut or Torn; Use of Device Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER THE CUSTOMER OPENED THE PACKAGE AND THE NEGATIVE PRESSURE SUCTION LINE WAS CONNECTED TO THE PRODUCT, THE SUCTION CONTROL VALVE COULD NOT BE PRESSED. THIS ISSUE OCCURRED AT A HOSPITAL AND HAD NOT BEEN OBSERVED DURING PREVIOUS USE. THERE WAS NO PATIENT INVOLVED. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND A COMPONENT DAMAGE/TORN AND THE SUCTION VALVE WITH THE CAP THAT COULD NOT ROTATE PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22020632 ↗
• MalfunctionApr 25, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21914851 ↗
• MalfunctionMar 19, 2025Connection Problem; Gas/Air Leak; Connection Problem; Gas/Air Leak

  IT WAS REPORTED THAT WHEN TESTING WITH A TEST LUNG BEFORE STARTING THE VENTILATOR, THERE WAS A LEAK NOTED ON THE SIX DEVICES. THERE WAS ALSO A CRACK IN THE Y-PIECE REGION (ON THE VENTILATOR SIDE). THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21642909 ↗
• MalfunctionMar 13, 2025Connection Problem; Gas/Air Leak; Connection Problem; Gas/Air Leak

  IT WAS REPORTED THAT WHEN TESTING WITH A TEST LUNG BEFORE STARTING THE VENTILATOR, THERE WAS A LEAK NOTED ON THE SIX DEVICES. THERE WAS ALSO A CRACK IN THE Y-PIECE REGION (ON THE VENTILATOR SIDE). THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21601227 ↗
• MalfunctionMar 13, 2025Connection Problem; Gas/Air Leak; Connection Problem; Gas/Air Leak

  IT WAS REPORTED THAT WHEN TESTING WITH A TEST LUNG BEFORE STARTING THE VENTILATOR, THERE WAS A LEAK NOTED ON THE SEVEN DEVICES. THERE WAS ALSO A CRACK IN THE Y-PIECE REGION (ON THE VENTILATOR SIDE). THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21601038 ↗
• MalfunctionMar 13, 2025Connection Problem; Gas/Air Leak; Connection Problem; Gas/Air Leak

  IT WAS REPORTED THAT WHEN TESTING WITH A TEST LUNG BEFORE STARTING THE VENTILATOR, THERE WAS A LEAK NOTED ON THE SIX DEVICES. THERE WAS ALSO A CRACK IN THE Y-PIECE REGION (ON THE VENTILATOR SIDE). THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21591657 ↗
• MalfunctionMar 13, 2025Connection Problem; Gas/Air Leak; Connection Problem; Gas/Air Leak

  IT WAS REPORTED THAT WHEN TESTING WITH A TEST LUNG BEFORE STARTING THE VENTILATOR, THERE WAS A LEAK NOTED ON THE SIX DEVICES. THERE WAS ALSO A CRACK IN THE Y-PIECE REGION (ON THE VENTILATOR SIDE). THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21591627 ↗
• MalfunctionMar 12, 2025Connection Problem; Gas/Air Leak; Connection Problem; Gas/Air Leak

  IT WAS REPORTED THAT WHEN TESTING WITH A TEST LUNG BEFORE STARTING THE VENTILATOR, THERE WAS A LEAK NOTED ON THE SIX DEVICES. THERE WAS ALSO A CRACK IN THE Y-PIECE REGION (ON THE VENTILATOR SIDE). THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21590662 ↗
• MalfunctionMar 12, 2025Connection Problem; Gas/Air Leak; Connection Problem; Gas/Air Leak

  IT WAS REPORTED THAT WHEN TESTING WITH A TEST LUNG BEFORE STARTING THE VENTILATOR, THERE WAS A LEAK NOTED ON THE SEVEN DEVICES. THERE WAS ALSO A CRACK IN THE Y-PIECE REGION (ON THE VENTILATOR SIDE). THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21590660 ↗
• MalfunctionJan 31, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER THE CUSTOMER OPENED THE PACKAGE AND CONNECTED THE NEGATIVE PRESSURE SUCTION LINE, THE NEGATIVE PRESSURE SUCTION BUTTON COULD NOT BE PRESSED. THIS PROBLEM HAD NOT OCCURRED DURING PREVIOUS USE. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE THREE SUCTION VALVES WITH THE CAP COULD NOT ROTATE PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21283722 ↗
• MalfunctionJan 31, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER THE CUSTOMER OPENED THE PACKAGE AND CONNECTED THE NEGATIVE PRESSURE SUCTION LINE, THE NEGATIVE PRESSURE SUCTION BUTTON COULD NOT BE PRESSED. THIS PROBLEM HAD NOT OCCURRED DURING PREVIOUS USE. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE THREE SUCTION VALVES WITH THE CAP COULD NOT ROTATE PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21283691 ↗
• MalfunctionJan 31, 2025Nonstandard Device; Material Split, Cut or Torn; Nonstandard Device; Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER THE CUSTOMER OPENED THE PACKAGE AND CONNECTED THE NEGATIVE PRESSURE SUCTION LINE, THE NEGATIVE PRESSURE SUCTION BUTTON COULD NOT BE PRESSED. THIS PROBLEM HAD NOT OCCURRED DURING PREVIOUS USE. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE THREE SUCTION VALVES WITH THE CAP COULD NOT ROTATE PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21283663 ↗
• MalfunctionDec 11, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USAGE, THE BREATHING SYSTEM SUCTION HAD FAILED THE PERFORMED LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20901776 ↗
• MalfunctionDec 11, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USAGE, THE BREATHING SYSTEM SUCTION HAD FAILED THE PERFORMED LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20901745 ↗
• MalfunctionDec 10, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USAGE, THE BREATHING SYSTEM SUCTION HAD FAILED THE PERFORMED LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20891678 ↗
• MalfunctionDec 10, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD FAIL LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20889903 ↗
• MalfunctionNov 29, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SUCTION CATHETER FAILED LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20810888 ↗
• MalfunctionNov 29, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SUCTION CATHETER FAILED LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20810832 ↗
• MalfunctionNov 28, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USAGE, THE BREATHING SYSTEM SUCTION HAD FAILED THE PERFORMED LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20805992 ↗
• MalfunctionNov 26, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USAGE, THE BREATHING SYSTEM SUCTION HAD FAILED THE PERFORMED LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20788664 ↗
• MalfunctionNov 8, 2024Device Damaged Prior to Use; Gas/Air Leak; Device Damaged Prior to Use; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, BOTH BREATHING SYSTEM SUCTION HAD A LEAK. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20641859 ↗