Maquet Sterigrip ARD567203900Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 03700712405120), received between Jan 18, 2024 and Jan 22, 2024 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Crack” (12 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2024Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  ON 9TH JANUARY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL EQUIPMENT - MAQUET STERIGRIP. IT WAS STATED THE MOUNTING WAS BROKEN WITH MISSING PARTICLES ON STERIGRIP, AND AS A RESULT THERE WAS A RISK OF DETACHMENT OF HANDLE. IT WAS CONFIRMED BY PHOTOGRAPHIC EVIDENCE THE SCREW SUPPORTS FROM HANDLE WERE BROKEN WITH MISSING PARTICLES. IT WAS FOUND THAT THE LIKELY CAUSE OF THE PROBLEM WOULD BE FAILURE TO COMPLY WITH THE MAXIMUM NUMBER OF USES/STERILIZATIONS RECOMMENDED BY THE MANUFACTURER. ACCORDING TO THE CUSTOMER'S CALCULATION, THE NUMBER OF TIMES USED/STERILIZED IS ON AVERAGE AROUND 104 TIMES, THUS FAR EXCEEDING THE RECOMMENDED AMOUNT- ACCORDING TO THE IFU 01781 EN 18 PAGE 92, THE HANDLES HAVE A MAXIMUM NUMBER OF 50 RECOMMENDED STERILIZATION CYCLES, WITH THE RISK OF FALLING OFF THE SUPPORT IF EXCEEDED. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES OR PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18550159 ↗
• MalfunctionJan 22, 2024Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  ON 9TH JANUARY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL EQUIPMENT - MAQUET STERIGRIP. IT WAS STATED THE MOUNTING WAS BROKEN WITH MISSING PARTICLES ON STERIGRIP, AND AS A RESULT THERE WAS A RISK OF DETACHMENT OF HANDLE. IT WAS CONFIRMED BY PHOTOGRAPHIC EVIDENCE THE SCREW SUPPORTS FROM HANDLE WERE BROKEN WITH MISSING PARTICLES. IT WAS FOUND THAT THE LIKELY CAUSE OF THE PROBLEM WOULD BE FAILURE TO COMPLY WITH THE MAXIMUM NUMBER OF USES/STERILIZATIONS RECOMMENDED BY THE MANUFACTURER. ACCORDING TO THE CUSTOMER'S CALCULATION, THE NUMBER OF TIMES USED/STERILIZED IS ON AVERAGE AROUND 104 TIMES, THUS FAR EXCEEDING THE RECOMMENDED AMOUNT- ACCORDING TO THE IFU 01781 EN 18 PAGE 92, THE HANDLES HAVE A MAXIMUM NUMBER OF 50 RECOMMENDED STERILIZATION CYCLES, WITH THE RISK OF FALLING OFF THE SUPPORT IF EXCEEDED. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES OR PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18550102 ↗
• MalfunctionJan 22, 2024Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  ON 9TH JANUARY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL EQUIPMENT - MAQUET STERIGRIP. IT WAS STATED THE MOUNTING WAS BROKEN WITH MISSING PARTICLES ON STERIGRIP, AND AS A RESULT THERE WAS A RISK OF DETACHMENT OF HANDLE. IT WAS CONFIRMED BY PHOTOGRAPHIC EVIDENCE THE SCREW SUPPORTS FROM HANDLE WERE BROKEN WITH MISSING PARTICLES. IT WAS FOUND THAT THE LIKELY CAUSE OF THE PROBLEM WOULD BE FAILURE TO COMPLY WITH THE MAXIMUM NUMBER OF USES/STERILIZATIONS RECOMMENDED BY THE MANUFACTURER. ACCORDING TO THE CUSTOMER'S CALCULATION, THE NUMBER OF TIMES USED/STERILIZED IS ON AVERAGE AROUND 104 TIMES, THUS FAR EXCEEDING THE RECOMMENDED AMOUNT- ACCORDING TO THE IFU 01781 EN 18 PAGE 92, THE HANDLES HAVE A MAXIMUM NUMBER OF 50 RECOMMENDED STERILIZATION CYCLES, WITH THE RISK OF FALLING OFF THE SUPPORT IF EXCEEDED. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES OR PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18550100 ↗
• MalfunctionJan 22, 2024Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  MANUFACTURER'S REFERENCE NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18550099 ↗
• MalfunctionJan 22, 2024Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  ON 9TH JANUARY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL EQUIPMENT - MAQUET STERIGRIP. IT WAS STATED THE MOUNTING WAS BROKEN WITH MISSING PARTICLES ON STERIGRIP, AND AS A RESULT THERE WAS A RISK OF DETACHMENT OF HANDLE. IT WAS CONFIRMED BY PHOTOGRAPHIC EVIDENCE THE SCREW SUPPORTS FROM HANDLE WERE BROKEN WITH MISSING PARTICLES. IT WAS FOUND THAT THE LIKELY CAUSE OF THE PROBLEM WOULD BE FAILURE TO COMPLY WITH THE MAXIMUM NUMBER OF USES/STERILIZATIONS RECOMMENDED BY THE MANUFACTURER. ACCORDING TO THE CUSTOMER'S CALCULATION, THE NUMBER OF TIMES USED/STERILIZED IS ON AVERAGE AROUND 104 TIMES, THUS FAR EXCEEDING THE RECOMMENDED AMOUNT- ACCORDING TO THE IFU 01781 EN 18 PAGE 92, THE HANDLES HAVE A MAXIMUM NUMBER OF 50 RECOMMENDED STERILIZATION CYCLES, WITH THE RISK OF FALLING OFF THE SUPPORT IF EXCEEDED. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES OR PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18550098 ↗
• MalfunctionJan 22, 2024Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  MANUFACTURER'S REFERENCE NUMBER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18550097 ↗
• MalfunctionJan 22, 2024Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  MANUFACTURER'S REFERENCE NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18550096 ↗
• MalfunctionJan 22, 2024Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  ON 9TH JANUARY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL EQUIPMENT - MAQUET STERIGRIP. IT WAS STATED THE MOUNTING WAS BROKEN WITH MISSING PARTICLES ON STERIGRIP, AND AS A RESULT THERE WAS A RISK OF DETACHMENT OF HANDLE. IT WAS CONFIRMED BY PHOTOGRAPHIC EVIDENCE THE SCREW SUPPORTS FROM HANDLE WERE BROKEN WITH MISSING PARTICLES. IT WAS FOUND THAT THE LIKELY CAUSE OF THE PROBLEM WOULD BE FAILURE TO COMPLY WITH THE MAXIMUM NUMBER OF USES/STERILIZATIONS RECOMMENDED BY THE MANUFACTURER. ACCORDING TO THE CUSTOMER'S CALCULATION, THE NUMBER OF TIMES USED/STERILIZED IS ON AVERAGE AROUND 104 TIMES, THUS FAR EXCEEDING THE RECOMMENDED AMOUNT- ACCORDING TO THE IFU 01781 EN 18 PAGE 92, THE HANDLES HAVE A MAXIMUM NUMBER OF 50 RECOMMENDED STERILIZATION CYCLES, WITH THE RISK OF FALLING OFF THE SUPPORT IF EXCEEDED. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES OR PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18550095 ↗
• MalfunctionJan 22, 2024Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  ON 9TH JANUARY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL EQUIPMENT - MAQUET STERIGRIP. IT WAS STATED THE MOUNTING WAS BROKEN WITH MISSING PARTICLES ON STERIGRIP, AND AS A RESULT THERE WAS A RISK OF DETACHMENT OF HANDLE. IT WAS CONFIRMED BY PHOTOGRAPHIC EVIDENCE THE SCREW SUPPORTS FROM HANDLE WERE BROKEN WITH MISSING PARTICLES. IT WAS FOUND THAT THE LIKELY CAUSE OF THE PROBLEM WOULD BE FAILURE TO COMPLY WITH THE MAXIMUM NUMBER OF USES/STERILIZATIONS RECOMMENDED BY THE MANUFACTURER. ACCORDING TO THE CUSTOMER'S CALCULATION, THE NUMBER OF TIMES USED/STERILIZED IS ON AVERAGE AROUND 104 TIMES, THUS FAR EXCEEDING THE RECOMMENDED AMOUNT- ACCORDING TO THE IFU 01781 EN 18 PAGE 92, THE HANDLES HAVE A MAXIMUM NUMBER OF 50 RECOMMENDED STERILIZATION CYCLES, WITH THE RISK OF FALLING OFF THE SUPPORT IF EXCEEDED. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES OR PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18550094 ↗
• MalfunctionJan 22, 2024Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  MANUFACTURER'S REFERENCE NUMBER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18550093 ↗
• MalfunctionJan 22, 2024Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  ON 9TH JANUARY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL EQUIPMENT - MAQUET STERIGRIP. IT WAS STATED THE MOUNTING WAS BROKEN WITH MISSING PARTICLES ON STERIGRIP, AND AS A RESULT THERE WAS A RISK OF DETACHMENT OF HANDLE. IT WAS CONFIRMED BY PHOTOGRAPHIC EVIDENCE THE SCREW SUPPORTS FROM HANDLE WERE BROKEN WITH MISSING PARTICLES. IT WAS FOUND THAT THE LIKELY CAUSE OF THE PROBLEM WOULD BE FAILURE TO COMPLY WITH THE MAXIMUM NUMBER OF USES/STERILIZATIONS RECOMMENDED BY THE MANUFACTURER. ACCORDING TO THE CUSTOMER'S CALCULATION, THE NUMBER OF TIMES USED/STERILIZED IS ON AVERAGE AROUND 104 TIMES, THUS FAR EXCEEDING THE RECOMMENDED AMOUNT- ACCORDING TO THE IFU 01781 EN 18 PAGE 92, THE HANDLES HAVE A MAXIMUM NUMBER OF 50 RECOMMENDED STERILIZATION CYCLES, WITH THE RISK OF FALLING OFF THE SUPPORT IF EXCEEDED. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES OR PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18550092 ↗
• MalfunctionJan 18, 2024Crack; Detachment of Device or Device Component; Crack; Detachment of Device or Device Component

  ON 9TH JANUARY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL EQUIPMENT - MAQUET STERIGRIP. IT WAS STATED THE MOUNTING WAS BROKEN WITH MISSING PARTICLES ON STERIGRIP, AND AS A RESULT THERE WAS A RISK OF DETACHMENT OF HANDLE. IT WAS CONFIRMED BY PHOTOGRAPHIC EVIDENCE THE SCREW SUPPORTS FROM HANDLE WERE BROKEN WITH MISSING PARTICLES. IT WAS FOUND THAT THE LIKELY CAUSE OF THE PROBLEM WOULD BE FAILURE TO COMPLY WITH THE MAXIMUM NUMBER OF USES/STERILIZATIONS RECOMMENDED BY THE MANUFACTURER. ACCORDING TO THE CUSTOMER'S CALCULATION, THE NUMBER OF TIMES USED/STERILIZED IS ON AVERAGE AROUND 104 TIMES, THUS FAR EXCEEDING THE RECOMMENDED AMOUNT- ACCORDING TO THE IFU 01781 EN 18 PAGE 92, THE HANDLES HAVE A MAXIMUM NUMBER OF 50 RECOMMENDED STERILIZATION CYCLES, WITH THE RISK OF FALLING OFF THE SUPPORT IF EXCEEDED. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES OR PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18533561 ↗