Puritan BennettRecalls & reported problems across all models

We found 119 models of Puritan Bennett by Covidien LP in the FDA's device registry (GUDID). Together they are named in 3,169 adverse event reports in the FDA's MAUDE database, received between Mar 9, 2017 and Sep 28, 2026 — classified as 10 deaths, 40 injuries, 3,119 malfunctions.

The most frequently reported specific device problem is “Improper Flow or Infusion” (1,282 reports).

18 FDA recall records name at least one of these models by its device identifier, 3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Puritan Bennett recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 22, 2023Open, Classified

   Inadequate internal fixation of the power inlet port to the cuff pressure manager device causes the external power inlet to became dislodged within the device housing after several uses, which prevents the device from being charged, and could lead to treatment delay.

   Z-2651-2023 · Root cause: Component design/selection · Recall details · FDA record ↗

2. Mar 25, 2022Open, Classified

   The audible alarm may not sound and/or the omni-directional LED visual alarm may not display during alarm states. Delayed awareness of alarm states may lead to delayed response or a delay of treatment, potentially resulting in hypoxia, dyspnea, cardiac arrest, or death.

   Z-0966-2022 · Root cause: Under Investigation by firm · names 79 of these models · Recall details · FDA record ↗

3. Nov 4, 2021Terminated

   Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

   Z-0353-2022 · Root cause: Reprocessing Controls · Recall details · FDA record ↗

4. Nov 4, 2021Terminated

   Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

   Z-0352-2022 · Root cause: Reprocessing Controls · Recall details · FDA record ↗

5. Nov 4, 2021Terminated

   Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

   Z-0350-2022 · Root cause: Reprocessing Controls · Recall details · FDA record ↗

6. Nov 4, 2021Terminated

   Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

   Z-0349-2022 · Root cause: Reprocessing Controls · Recall details · FDA record ↗

7. Nov 4, 2021Terminated

   Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

   Z-0348-2022 · Root cause: Reprocessing Controls · Recall details · FDA record ↗

8. Nov 4, 2021Terminated

   Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

   Z-0347-2022 · Root cause: Reprocessing Controls · Recall details · FDA record ↗

9. Nov 4, 2021Terminated

   Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

   Z-0346-2022 · Root cause: Reprocessing Controls · Recall details · FDA record ↗

10. Nov 4, 2021Terminated

    Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

    Z-0345-2022 · Root cause: Reprocessing Controls · Recall details · FDA record ↗

11. Nov 4, 2021Terminated

    Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

    Z-0344-2022 · Root cause: Reprocessing Controls · Recall details · FDA record ↗

12. Nov 4, 2021Terminated

    Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

    Z-0343-2022 · Root cause: Reprocessing Controls · Recall details · FDA record ↗

13. Nov 4, 2021Terminated

    Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

    Z-0342-2022 · Root cause: Reprocessing Controls · Recall details · FDA record ↗

14. Nov 4, 2021Terminated

    Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

    Z-0341-2022 · Root cause: Reprocessing Controls · Recall details · FDA record ↗

15. Nov 4, 2021Terminated

    Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

    Z-0340-2022 · Root cause: Reprocessing Controls · Recall details · FDA record ↗

16. Nov 4, 2021Terminated

    Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

    Z-0339-2022 · Root cause: Reprocessing Controls · Recall details · FDA record ↗

17. Nov 4, 2021Terminated

    Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

    Z-0338-2022 · Root cause: Reprocessing Controls · Recall details · FDA record ↗

18. Oct 16, 2020Open, Classified

    In-house lab observations and customer reports of overheating and/or thermal damage to the battery pack, create the risk of exposure to smoke or hazardous materials, which may result in burns and/or bronchospasm,

    Z-0425-2021 · Root cause: Device Design · names 45 of these models · Recall details · FDA record ↗

Most reported Puritan Bennett problems

Puritan Bennett models

119 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.

• Puritan Bennett 980X3ENDIUU

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls3 deaths827 reports
• Puritan Bennett 980X1ENDIUU

  VENTILATOR, CONTINUOUS, FACILITY USE
  3 recalls1 death562 reports
• Puritan Bennett 4-840220DIUA-EN

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 deaths460 reports
• Puritan Bennett 980X1JADIJJ

  VENTILATOR, CONTINUOUS, FACILITY USE
  3 recalls161 reports
• Puritan Bennett 980A1ENNISB

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls86 reports
• Puritan Bennett 980U1ENDICU

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls82 reports
• Puritan Bennett 980A3ENNISB

  VENTILATOR, CONTINUOUS, FACILITY USE
  3 recalls1 death24 reports
• Puritan Bennett 980X3JADIJJ

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls70 reports
• Puritan Bennett 4-840120DIUU-US

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 death159 reports
• Puritan Bennett 980S1ENDICU

  VENTILATOR, CONTINUOUS, FACILITY USE
  3 recalls6 reports
• Puritan Bennett 980S3ENDICU

  VENTILATOR, CONTINUOUS, FACILITY USE
  3 recalls4 reports
• Puritan Bennett 980U1ESDIUC

  VENTILATOR, CONTINUOUS, FACILITY USE
  3 recalls2 reports
• Puritan Bennett 980X1ENAIQC

  VENTILATOR, CONTINUOUS, FACILITY USE
  3 recalls1 report
• Puritan Bennett 980X1ENDIPC

  VENTILATOR, CONTINUOUS, FACILITY USE
  3 recalls0 reports
• Puritan Bennett 980U3ENDICU

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls33 reports
• Puritan Bennett 980X1ENNISB

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls25 reports
• Puritan Bennett 980X1ESDIEC

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls19 reports
• Puritan Bennett 980U1ENASAA

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls17 reports
• Puritan Bennett 980X1PLDIPC

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls12 reports
• Puritan Bennett 980X3PLDIPC

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls6 reports
• Puritan Bennett 980U3ESDIUU

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls6 reports
• Puritan Bennett 980X3ENDIJI

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls5 reports
• Puritan Bennett 980U1PTDIUNA

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls4 reports
• Puritan Bennett 10049998

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 deaths102 reports
• Puritan Bennett 980S1ESDIUU

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls2 reports
• Puritan Bennett 980U1ESDIUU

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls2 reports
• Puritan Bennett 980X1NLDRAC

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls1 report
• Puritan Bennett 980X3ITDIEC

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls1 report
• Puritan Bennett 980X3ENNISB

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls1 report
• Puritan Bennett 980X3SKNISC

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls1 report
• Puritan Bennett 980X3ENDRAC

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls1 report
• Puritan Bennett 980U3ESDIUC

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls1 report
• Puritan Bennett 980U3PTDIUNA

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls1 report
• Puritan Bennett 980X1PTDIPC

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls0 reports
• Puritan Bennett 980X1HUNISC

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls0 reports
• Puritan Bennett 980X1HRDRAC

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls0 reports
• Puritan Bennett 980X1TRDRAC

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls0 reports
• Puritan Bennett 980X1ENDIJI

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls0 reports
• Puritan Bennett 980X1BGDRAC

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls0 reports
• Puritan Bennett 980X3ENASAA

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls0 reports
• Puritan Bennett 980X3PTDIPC

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls0 reports
• Puritan Bennett 980X3FRAIQC

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls0 reports
• Puritan Bennett 980X3HUNISC

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls0 reports
• Puritan Bennett 980X3ENDIPB

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls0 reports
• Puritan Bennett 980X3TRDRAC

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls0 reports
• Puritan Bennett 980X3RUDRAC

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls0 reports
• Puritan Bennett 980S1PTDIUNA

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls0 reports
• Puritan Bennett 980S3ESDIUA

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls0 reports
• Puritan Bennett 980S3ESDIUC

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls0 reports
• Puritan Bennett 980U3ENDIUU-LA

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls0 reports
• Puritan Bennett 980S3ESDIUU

  VENTILATOR, CONTINUOUS, FACILITY USE
  2 recalls0 reports
• Puritan Bennett 4-840120DIJJ-JP

  VENTILATOR, CONTINUOUS, FACILITY USE
  87 reports
• Puritan Bennett 980X3ENDIUU-RMF

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall27 reports
• Puritan Bennett 180-03

  Cuff, tracheal tube, inflatable
  1 recall23 reports
• Puritan Bennett 980X1DEDRAC

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall15 reports
• Puritan Bennett 980X1FRAIQC

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall9 reports
• Puritan Bennett 980S1ESDIUA

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall7 reports
• Puritan Bennett 980U3ENASAA

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall6 reports
• Puritan Bennett 980X1ENASAA

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall3 reports
• Puritan Bennett 980X1ITDIEC

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall3 reports
• Puritan Bennett 980X1ELAIQC

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall2 reports
• Puritan Bennett 980X1SLDRAC

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall2 reports
• Puritan Bennett 980X3DEDRAC

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall2 reports
• Puritan Bennett 980X3ENDIPP

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall1 report
• Puritan Bennett 980X3RODRAC

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall1 report
• Puritan Bennett 980U1ENDIUU-LA

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall1 report
• Puritan Bennett 980S1FRDICU

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall0 reports
• Puritan Bennett 980U1FRDICU

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall0 reports
• Puritan Bennett 980X1CSNISC

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall0 reports
• Puritan Bennett 980X1SKNISC

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall0 reports
• Puritan Bennett 980X1ENDIPP

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall0 reports
• Puritan Bennett 980X1SRDRAC

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall0 reports
• Puritan Bennett 980X1RODRAC

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall0 reports
• Puritan Bennett 980X1ENDRAC

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall0 reports
• Puritan Bennett 980X3ESDIEC

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall0 reports
• Puritan Bennett 980X3ENDISS

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall0 reports
• Puritan Bennett 980X3SVAIQC

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall0 reports
• Puritan Bennett 980X3NLDRAC

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall0 reports
• Puritan Bennett 980X3CSNISC

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall0 reports
• Puritan Bennett 980X3ENAIQC

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall0 reports
• Puritan Bennett 980X3SRDRAC

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall0 reports
• Puritan Bennett 980X3BGDRAC

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall0 reports
• Puritan Bennett 980X3RUDIEC

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall0 reports
• Puritan Bennett 980X2ENDIUU

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall0 reports
• Puritan Bennett 980S1ESDIUC

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall0 reports
• Puritan Bennett 980U1ESDIUA

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall0 reports
• Puritan Bennett 980U3ESDIUA

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall0 reports
• Puritan Bennett 980X1DEDISS

  VENTILATOR, CONTINUOUS, FACILITY USE
  1 recall0 reports
• Puritan Bennett 4-840220DIEC-IT

  VENTILATOR, CONTINUOUS, FACILITY USE
  35 reports
• Puritan Bennett 4-840220DIPC-PL

  VENTILATOR, CONTINUOUS, FACILITY USE
  30 reports
• Puritan Bennett 4-840220DIEC-SP

  VENTILATOR, CONTINUOUS, FACILITY USE
  28 reports
• Puritan Bennett 4-840220DRAC-GR

  VENTILATOR, CONTINUOUS, FACILITY USE
  27 reports
• Puritan Bennett 4-840220NISB-EN

  VENTILATOR, CONTINUOUS, FACILITY USE
  22 reports
• Puritan Bennett G-760110DIUU-JP

  VENTILATOR, CONTINUOUS, FACILITY USE
  19 reports
• Puritan Bennett G-061949-00

  VENTILATOR, CONTINUOUS, FACILITY USE
  18 reports
• Puritan Bennett 4-840120DICU-EN

  VENTILATOR, CONTINUOUS, FACILITY USE
  13 reports
• Puritan Bennett 4-840220AIQC-FR

  VENTILATOR, CONTINUOUS, FACILITY USE
  13 reports
• Puritan Bennett G-760220DIUA-EN

  VENTILATOR, CONTINUOUS, FACILITY USE
  11 reports
• Puritan Bennett 4-840220ASAA-EN

  VENTILATOR, CONTINUOUS, FACILITY USE
  9 reports
• Puritan Bennett 4-840220DIPC-PR

  VENTILATOR, CONTINUOUS, FACILITY USE
  9 reports

Recent Puritan Bennett adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Smoking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926498 ↗
• MalfunctionSep 28, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926443 ↗
• MalfunctionSep 28, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926361 ↗
• MalfunctionSep 24, 2026No Flow

  Patient problems: Bradycardia; Low Oxygen Saturation

  MAUDE report 50891495 ↗
• MalfunctionJun 30, 2026Improper Flow or Infusion

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR DISPLAYED A BACKGROUND FAULT DIAGNOSTIC CODE INDICATING THE VENTILATOR ENTERED INTO BACK UP VENTILATION. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25669423 ↗
• MalfunctionJun 25, 2026Improper Flow or Infusion

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT THIS 980 VENTILATOR GENERATED A BACKGROUND FAULT DIAGNOSTIC CODE INDICATING THE VENTILATOR ENTERED INTO BACK UP VENTILATION. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25619696 ↗
• MalfunctionJun 19, 2026Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT THE 980 VENTILATOR DID NOT PASS THE EXTENDED SELF TEST (EST) WITH AN "INSPIRATORY AUTOZERO SOLENOID NOT OPERATIONAL" MESSAGE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25562364 ↗
• MalfunctionJun 19, 2026Improper Flow or Infusion; Output Problem

  IT WAS REPORTED THAT DURING SERVICE THIS 980 VENTILATOR GENERATED TWO BACKGROUND CODES INSPIRATORY PRESSURE AUTO OFFSET FAILED AND PNEUMATIC DIGITAL CONVERTER FAILURE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25561763 ↗
• MalfunctionJun 18, 2026No Flow

  IT WAS REPORTED BY THE NATIONAL MEDICAL AND PRODUCT ADMINISTRATION (NMPA), AND NOT REPORTED DIRECTLY TO MEDTRONIC BY THE CUSTOMER THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR GENERATED A CONTINUOUS HARDWARE ALARM INDICATING AIR PROPORTIONAL SOLENOID (PSOL) STUCK OPEN AND THE UNIT WAS UNABLE TO OPERATE. THE PATIENT'S OXYGEN SATURATION DROPPED TO 95% AND RECOVERED AFTER UNIT REPLACEMENT. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND WAS PLACED IN AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: Low Oxygen Saturation

  MAUDE report 25553319 ↗
• MalfunctionJun 18, 2026Output Problem

  IT WAS REPORTED THAT THE 980 VENTILATOR DID NOT PASS THE SHORT SELF TEST (SST) AND EXTENDED SELF TEST (EST) FOR THE AUTO ZERO TRANSDUCER ON THE EXHALATION SIDE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25546589 ↗
• MalfunctionJun 12, 2026Improper Flow or Infusion

  IT WAS REPORTED THAT THIS 980 VENTILATOR DID NOT PASS THE EXHALATION SUBSYSTEM PORTION OF THE POWER ON SELF TEST (POST) WITH A PNEUMATICS INTERFACE EXHALATION ANALOG-DIGITAL CONVERTER (ADC) OUT OF RANGE MESSAGE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25488633 ↗
• MalfunctionJun 11, 2026No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR GENERATED A BACKGROUND CHECK BREATH DELIVERY UNIT (BDU) ALERT INDICATING A BD ELECTRICALLY ERASABLE PROGRAMMABLE READ ONLY MEMORY (EEPROM) CHECKSUM ERROR, WHICH COULD LEAD TO LOSS OF VENTILATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25479897 ↗
• MalfunctionMay 27, 2026Improper Flow or Infusion

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR WAS IN AN INOPERATIVE STATUS. THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25300335 ↗
• MalfunctionMay 22, 2026Improper Flow or Infusion

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 980 VENTILATOR WAS INOPERATIVE (VENT INOP). THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25260270 ↗
• MalfunctionMay 22, 2026Product Quality Problem; No Flow

  IT WAS REPORTED THAT DURING ANNUAL PREVENTATIVE MAINTENANCE, WHEN THIS 980 VENTILATOR HAD A NEW BREATH DELIVERY (BD) POWER CONTROL DISTRIBUTION ASSEMBLY WAS REPLACED, WHEN IT WAS POWERED ON, IT ALARMED, WOULD NOT START UP AND COULD NOT BE USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25255627 ↗

Other Covidien LP products

• Endo GIA48 models · 26,277 reports · 8 recalls
• Endo GIA Ultra3 models · 15,650 reports
• Shiley387 models · 9,392 reports · 5 recalls
• Signia16 models · 8,201 reports · 6 recalls
• LigaSure32 models · 7,283 reports · 1 recall
• Tri-Staple 2.037 models · 4,892 reports · 2 recalls
• Polysorb291 models · 4,564 reports · 2 recalls
• EEA39 models · 4,432 reports · 1 recall