Sphere™ Inflation Device QL2030Recalls & reported problems
Atrion Medical Products, Inc. · Inflation Device Atrion Part Number 96271A: 20mL, 30atm · Class 2
All models of Sphere Inflation Device (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Atrion Sphere inflation device is a hand-held syringe used to inflate balloons. The 27 reports mostly describe white powder or other foreign material found on the handle and gauge when the package was opened, plus fittings that did not seat properly and parts coming loose. No deaths or injuries are described, and in the reported cases the device was wiped off and used without problems. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00827002310278), received between Jan 24, 2018 and Apr 1, 2021 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (4 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 16, 2026.
Most reported problems
Device problems
- Contamination /Decontamination Problem4
- Device Contamination with Chemical or Other Material4
- Fitting Problem4
- Appropriate Device Problem Term/Code Not Available3
- Packaging Problem3
- Detachment Of Device Component2
- Detachment of Device or Device Component2
- Material Separation2
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- No Known Impact Or Consequence To Patient11
- No Consequences Or Impact To Patient4
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 27 reports, 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 ↗MalfunctionSep 11, 2018Misconnection; Misconnection
IT WAS REPORTED, DURING AN UNSPECIFIED PROCEDURE, THE STOPCOCK OF THE SPHERE INFLATION DEVICE WOULD NOT ATTACH TO THE COOK BALLOON. THE STOPCOCK WOULD NOT SEAL CORRECTLY. IT KEPT SPINNING AS IF IT WERE STRIPPED. THE PHYSICIAN REMOVED THE STOPCOCK AND PROCEEDED WITH NO FURTHER ISSUES. NO PATIENT HARM WAS REPORTED AND NO ADDITIONAL PROCEDURES WERE REQUIRED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7865529 ↗MalfunctionAug 27, 2018Material Separation; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7819528 ↗MalfunctionAug 24, 2018Fitting Problem; Fitting Problem
IT WAS REPORTED, THE STOP COCK OF THE SPHERE INFLATION DEVICE WOULD NOT PROPERLY CONNECT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE. INITIAL ACCESS WAS GAINED THROUGH THE LEFT RADIAL VEIN TO THE CEPHALIC VEIN. THE PHYSICIAN ATTEMPTED TO CONNECT THE STOP COCK OF THE SPHERE INFLATION DEVICE TO AN ANGIOPLASTY BALLOON DEVICE, BUT IT WAS UNSUCCESSFUL. THEREFORE, ANOTHER MANUFACTURE'S DEVICE WAS USED INSTEAD. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7812840 ↗MalfunctionAug 3, 2018Fitting Problem; Fitting Problem
IT WAS REPORTED, THE THREE WAY STOP COCK WOULD NOT TIGHTEN ON THE SPHERE INFLATION DEVICE. THE DEVICE WAS BEING USED DURING A BALLOON ANGIOPLASTY PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS NOR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7748802 ↗MalfunctionJul 31, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7736742 ↗MalfunctionJul 26, 2018Fitting Problem; Fitting Problem
IT WAS REPORTED, THE STOP COCK ON THE SPHERE INFLATION DEVICE WOULD NOT LOCK/ATTACH TO THE COOK 35 LP BALLOON. THIS DEVICE DOES NOT MAKE PATIENT CONTACT. THE RIGHT LOWER LEG ANGIOPLASTY PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER INFLATION DEVICE. ACCORDING TO THE COMPLAINANT, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7722083 ↗MalfunctionJul 25, 2018Fracture; Fracture
IT WAS REPORTED, AN ARTERIOVENOUS FISTULA (AVF) ANGIOPLASTY PROCEDURE WAS INITIATED VIA BRACHIAL ARTERY TO TREAT A LESION IN THE CEPHALIC VEIN ARCH. PATIENT'S ANATOMY WAS NEITHER TORTUROUS, ANGULATED NOR CALCIFIED. THE PHYSICIAN INTENDED TO INFLATE A 6X10 CENTIMETER (CM) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON (MANUFACTURER NOT SPECIFIED) TO 10 ATMOSPHERES (ATM) USING A MIXTURE OF CONTRAST TO SALINE IN A 1:1 RATIO WITHOUT SUCCESS. A FRACTURE WAS NOTED AT THE BODY OF THE SPHERE INFLATION DEVICE. AS A RESULT, THE PHYSICIAN WAS UNABLE TO INFLATE THE ANGIOPLASTY BALLOON. THE COMPLAINT DEVICE WAS CHANGED OUT FOR A NEW SPHERE INFLATION DEVICE WHICH ALLOWED THE PROCEDURE TO BE COMPLETED SUCCESSFULLY. ACCORDING TO THE COMPLAINANT, NO PATIENT ADVERSE EFFECTS OCCURRED AS A RESULT OF THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7720205 ↗MalfunctionJul 24, 2018Fitting Problem; Fitting Problem
IT WAS REPORTED, THE STOP COCK OF THE SPHERE INFLATION DEVICE WOULD NOT TIGHTEN. AT THE TIME OF THE EVENT, A BALLOON ANGIOPLASTY WAS BEING PERFORMED; HOWEVER, THE COMPLAINT DEVICE NEVER MADE PATIENT CONTACT. THE COMPLAINANT REPORTED THIS EVENT DID NOT NEGATIVELY AFFECT THE PROCEDURE. IT WAS COMPLETED WITHOUT ANY ADVERSE EFFECTS TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7713956 ↗MalfunctionJul 11, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED, THE 3-WAY STOP COCK DOES NOT TIGHTEN AND "POPS" OFF OF THE SPHERE INFLATION DEVICE. THE DEVICE DID NOT MAKE PATIENT CONTACT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR INVESTIGATION.
Patient problems: No Patient Involvement
MAUDE report 7678111 ↗MalfunctionMay 31, 2018Detachment Of Device Component; Detachment Of Device Component
IT WAS REPORTED THAT THE STOPCOCK ON THE SPHERE INFLATION DEVICE REPEATEDLY POPPED OFF PRIOR TO PATIENT CONTACT. ANOTHER DEVICE WAS OPENED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7558509 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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