Sphere Inflation DeviceRecalls & reported problems across all models
Atrion Medical Products, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 31
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 2 models of Sphere Inflation Device by Atrion Medical Products, Inc. in the FDA's device registry (GUDID). Together they are named in 31 adverse event reports in the FDA's MAUDE database, received between Dec 12, 2016 and Apr 1, 2021 — classified as 1 injury, 30 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (5 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. 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
Most reported Sphere Inflation Device problems
Device problems
- Device Contamination with Chemical or Other Material5
- Appropriate Device Problem Term/Code Not Available4
- Contamination /Decontamination Problem4
- Fitting Problem4
- Packaging Problem3
- Detachment Of Device Component2
- Detachment of Device or Device Component2
- Material Separation2
Patient problems
- No Known Impact Or Consequence To Patient13
- No Clinical Signs, Symptoms or Conditions11
- No Consequences Or Impact To Patient5
- No Patient Involvement1
- Sepsis1
Sphere Inflation Device models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Sphere™ Inflation Device QL2030Syringe, Balloon Inflation27 reports
- Sphere™ Inflation Device QL2030PRSyringe, Balloon Inflation4 reports
Recent Sphere Inflation Device adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11604335 ↗MalfunctionApr 1, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
AS REPORTED, WHEN THE USER OPENED THE PACKAGE FOR A SPHERE INFLATION DEVICE, A FOREIGN WHITE SUBSTANCE WAS CONFIRMED ON THE DEVICE. THERE WAS A SMALL AMOUNT OF WHITE POWDER ON THE HANDLE AND THE GAUGE METER. THE USER WIPED IT OFF WITH GAUZE AND USED THE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE EFFECTS REPORTED DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11604307 ↗MalfunctionApr 1, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
AS REPORTED, WHEN THE USER OPENED THE PACKAGE FOR A SPHERE INFLATION DEVICE, A FOREIGN WHITE SUBSTANCE WAS CONFIRMED ON THE DEVICE. THERE WAS A SMALL AMOUNT OF WHITE POWDER ON THE HANDLE AND THE GAUGE METER. THE USER WIPED IT OFF WITH GAUZE AND USED THE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE EFFECTS REPORTED DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11601907 ↗MalfunctionApr 1, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
AS REPORTED, WHEN THE USER OPENED THE PACKAGE FOR A SPHERE INFLATION DEVICE, A FOREIGN WHITE SUBSTANCE WAS CONFIRMED ON THE DEVICE. THERE WAS A SMALL AMOUNT OF WHITE POWDER ON THE HANDLE AND THE GAUGE METER. THE USER WIPED IT OFF WITH GAUZE AND USED THE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE EFFECTS REPORTED DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11601906 ↗MalfunctionMar 26, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11574874 ↗MalfunctionMar 26, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11574864 ↗MalfunctionMar 26, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11574862 ↗MalfunctionMar 24, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11564405 ↗MalfunctionMar 12, 2021Packaging Problem; Packaging Problem
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11476190 ↗MalfunctionMar 12, 2021Packaging Problem; Packaging Problem
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11475347 ↗MalfunctionMar 12, 2021Packaging Problem; Packaging Problem
AS REPORTED, PRIOR TO AN UNKNOWN PROCEDURE A SPHERE INFLATION DEVICE WAS OPENED WHEN AN UNKNOWN WHITE SUBSTANCE WAS FOUND ON THE HANDLE AND THE METER. THE USER THEN WIPED OFF THE SECOND DEVICE WITH GAUZE AND USED IT IN THE PROCEDURE. IT WAS NOTED THE SURFACE OF THE TYVEK ON THE INTERIOR OF THE PACKAGE WAS SCRAPED. NO ADVERSE EFFECTS OCCURRED DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11475305 ↗MalfunctionSep 11, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10522499 ↗MalfunctionSep 18, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9082906 ↗MalfunctionSep 18, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9082886 ↗MalfunctionSep 11, 2018Misconnection; Misconnection
IT WAS REPORTED, THE COMPLAINT (B)(4) WAS USED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY IN THE BRACHIAL ARTERY. APPROACH WAS GAINED FROM THE LEFT SHUNT. IN ORDER TO REMOVE THE AIR FROM ANOTHER MANUFACTURER'S BALLOON CATHETER (DETAIL: UNKNOWN) PRIOR TO INSERTION OF IT INTO THE BODY, THE USER ATTEMPTED TO CONNECT THE THREE-WAY STOPCOCK INCLUDED IN THE CID- SET TO THE CATHETER. HOWEVER, THE STOPCOCK WOULD NOT CONNECT PROPERLY. ANOTHER MANUFACTURER'S THREE-WAY STOPCOCK WAS USED INSTEAD AND THE PROCEDURE WAS COMPLETED. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7865855 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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