Sphere™ Inflation Device QL2030PRRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002255715), received between Dec 12, 2016 and Aug 10, 2018 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, THE SPHERE INFLATION DEVICE LEAKED DURING A BALLOON ARTERY DILATATION PROCEDURE. IT WAS INITIALLY REPORTED THAT A MIXTURE OF BLOOD AND CONTRAST BEGAN LEAKING FROM THE "PLUNGER" OF THE DEVICE DURING INFLATION OF ANOTHER MANUFACTURER'S BALLOON CATHETER, BUT LATER CLARIFIED THAT "THERE WAS NO AMOUNT OF BLOOD LOSS, JUST SOME LEAKING THROUGH THE SYRINGE/BARREL." ANOTHER SPHERE INFLATION DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. 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 7774239 ↗
• InjuryJun 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, A FEMALE PATIENT IN HER "(B)(6)" WITH A LEFT FOOT, NON-HEALING VASCULAR ULCER, UNDERWENT A STENT PLACEMENT (SITE NOT SPECIFIED) ON (B)(6) 2018 IN AN OUTPATIENT FACILITY. MULTIPLE COOK PRODUCTS WERE USED. ON (B)(6) 2018, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A FEVER (TEMPERATURE UNKNOWN TO COMPLAINANT) AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT WAS DIAGNOSED WITH SEPSIS WHICH WAS TREATED WITH "FLUIDS AND IV ANTIBIOTICS" AND IS "DOING FINE". REPORTEDLY, LAB RESULTS INDICATE A STRAIN OF STREP WAS IDENTIFIED, HOWEVER, NO FURTHER INFORMATION HAS BEEN PROVIDED. PER THE COMPLAINANT: "SEVERAL COOK PRODUCTS WERE INVOLVED WITH ORIGINAL PROCEDURE, UNKNOWN AND NOT ALLEGED AT THIS TIME IF ANY OF THEM MAY HAVE CONTRIBUTED TO THIS." A SECTION OF THE DEVICES DID NOT REMAIN IN THE PATIENT'S ANATOMY. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND RELEVANT MEDICAL HISTORY HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME. PLEASE REFERENCE ADDITIONAL MEDWATCH NUMBERS REGARDING ALL COOK PRODUCTS IN USE DURING THE PROCEDURE: CID-20-30-NG (1820334-2018-01470) THIS REPORT; KCFW-5.0-38-RB (1820334-2018-01613); KCFW-6.0-18/38-45-RB-ANL0-HC (1820334-201

  Patient problems: Sepsis

  MAUDE report 7633760 ↗
• MalfunctionMay 10, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A SMALL PIECE OF BLACK PLASTIC WAS FOUND INSIDE THE SYRINGE OF THE SPHERE INFLATION DEVICE. IT APPEARED AS IF IT WAS SOME DEBRIS FROM THE PLUNGER. THE UNSPECIFIED PROCEDURE WAS COMPLETED AS PLANNED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE NOR WAS ANY FOREIGN MATERIAL RETAINED IN THE PATIENT'S ANATOMY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7502447 ↗
• MalfunctionDec 12, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  INFORMATION WAS PROVIDED THAT A PIECE OF METAL WAS NOTED TO BE IN THE CHAMBER OF THE DEVICE WHERE THE SALINE GOES IN. THIS HAD NOT BEEN INTRODUCED IN THE PATIENT; HOWEVER, IT WAS ON THE TABLE WITH THE PATIENT. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6167381 ↗