SYNFLATE 03.804.701SRecalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 10705034722719), received between Mar 30, 2018 and May 19, 2026 — classified as 1 injury, 59 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (27 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THIS WAS A VERTEBROPLASTY FOR A VERTEBRAL FRACTURE ON (B)(6) 2026. THE BALLOON COULD NOT BE INSERTED INTO THE WORKING SLEEVE. THE NEGATIVE PRESSURE OPERATION WAS PERFORMED, AND INSERTION WAS TRIED MULTIPLE TIMES, BUT THE BALLOON STILL COULD NOT BE INSERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY USING ANOTHER NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25219674 ↗
• MalfunctionMay 13, 2026Material Integrity Problem

  IT WAS REPORTED THAT SYNFLATE VERTEBRAL BALLOON MED WAS INVOLVED IN AN INTRAOPERATIVE EVENT DURING A BALLOON KYPHOPLASTY PROCEDURE. THE REPORTED FAILURE INVOLVED THE BALLOON TEARING DURING INFLATION, RESULTING IN CONTRAST MEDIUM DISPERSING WITHIN THE VERTEBRAL BODY, LIKELY DUE TO CONTACT WITH A BONE EDGE. WHEN ATTEMPTING TO REMOVE THE DAMAGED BALLOON, A PORTION TORE OFF AND REMAINED IN SITU. THIS LED TO A 30-MINUTE SURGICAL DELAY, REQUIRED ADDITIONAL X-RAYS AND CT IMAGING, NECESSITATED AN EXTENSION OF ACCESS, AND RESULTED IN INCREASED BLOOD LOSS AND A HIGHER RISK OF INFECTION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25160795 ↗
• MalfunctionMay 13, 2026Material Integrity Problem

  IT WAS REPORTED THAT SYNFLATE VERTEBRAL BALLOON MED WAS INVOLVED IN AN INTRAOPERATIVE EVENT DURING A BALLOON KYPHOPLASTY PROCEDURE. THE REPORTED FAILURE INVOLVED THE BALLOON TEARING DURING INFLATION, RESULTING IN CONTRAST MEDIUM DISPERSING WITHIN THE VERTEBRAL BODY, LIKELY DUE TO CONTACT WITH A BONE EDGE. WHEN ATTEMPTING TO REMOVE THE DAMAGED BALLOON, A PORTION TORE OFF AND REMAINED IN SITU. THIS LED TO A 30-MINUTE SURGICAL DELAY, REQUIRED ADDITIONAL X-RAYS AND CT IMAGING, NECESSITATED AN EXTENSION OF ACCESS, AND RESULTED IN INCREASED BLOOD LOSS AND A HIGHER RISK OF INFECTION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25160727 ↗
• MalfunctionFeb 19, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THIS WAS A BKP +FIXATION(L3) PERFORMED ON (B)(6) 2026. WHEN THE SURGEON TRIED TO INSERT THE BALLOON INTO THE WORKING SLEEVE, IT WOULDN'T GO IN. THE SURGEON USED A DIFFERENT ONE AND IT WORKED WITHOUT ANY PROBLEMS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINS OF DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390664 ↗
• MalfunctionJan 27, 2026Inflation Problem; Compatibility Problem

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS VERTEBROPLASTY(L1) FOR VERTEBRAL FRACTURE ON (B)(6) 2026. AFTER DEFLATION, DIFFICULTY IN REMOVING THE BALLOONS OCCURRED ON BOTH SIDES. DESPITE TRYING TO RESOLVE THE ISSUE, THE BALLOONS COULD NOT BE REMOVED, SO THE SURGEON REMOVED THE WORKING SLEEVE, AND THE BALLOONS WERE CUT AND REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINS OF DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24189263 ↗
• MalfunctionJan 27, 2026Inflation Problem; Compatibility Problem

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS VERTEBROPLASTY(L1) FOR VERTEBRAL FRACTURE ON (B)(6) 2026. AFTER DEFLATION, DIFFICULTY IN REMOVING THE BALLOONS OCCURRED ON BOTH SIDES. DESPITE TRYING TO RESOLVE THE ISSUE, THE BALLOONS COULD NOT BE REMOVED, SO THE SURGEON REMOVED THE WORKING SLEEVE, AND THE BALLOONS WERE CUT AND REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINS OF DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24189251 ↗
• MalfunctionJan 26, 2026Inflation Problem; Compatibility Problem

  IT WAS REPORTED A PERCUTANEOUS VERTEBROPLASTY(T12) FOR VERTEBRAL FRACTURE OCCURRED ON JAN 13, 2026. AFTER DEFLATION, WHEN THE SURGEON TRIED TO REMOVE THE BALLOON, IT BECAME DIFFICULT TO REMOVE THE BALLOON. DESPITE TRYING VARIOUS METHODS, IT WAS NOT POSSIBLE TO REMOVE IT, SO THE WORKING SLEEVE WAS REMOVED AND THE ACCESS NEEDLE WAS REINSERTED, AND THE PROCEDURE HAD TO BE REPEATED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINS OF DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24177346 ↗
• MalfunctionJan 26, 2026Inflation Problem; Compatibility Problem

  IT WAS REPORTED A PERCUTANEOUS VERTEBROPLASTY(L1) FOR VERTEBRAL FRACTURE WAS PERFORMED ON (B)(6) 2026. AFTER DEFLATION, WHEN THE SURGEON TRIED TO REMOVE THE BALLOON, IT BECAME DIFFICULT TO REMOVE THE BALLOON. DESPITE TRYING VARIOUS METHODS, IT WAS NOT POSSIBLE TO REMOVE IT, SO THE WORKING SLEEVE WAS REMOVED AND THE ACCESS NEEDLE WAS REINSERTED, AND THE PROCEDURE HAD TO BE REPEATED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINS OF DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24176886 ↗
• MalfunctionJan 26, 2026Inflation Problem; Compatibility Problem

  IT WAS REPORTED A PERCUTANEOUS VERTEBROPLASTY(L1) FOR VERTEBRAL FRACTURE WAS PERFORMED ON (B)(6) 2026. AFTER DEFLATION, WHEN THE SURGEON TRIED TO REMOVE THE BALLOON, IT BECAME DIFFICULT TO REMOVE THE BALLOON. DESPITE TRYING VARIOUS METHODS, IT WAS NOT POSSIBLE TO REMOVE IT, SO THE WORKING SLEEVE WAS REMOVED AND THE ACCESS NEEDLE WAS REINSERTED, AND THE PROCEDURE HAD TO BE REPEATED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINS OF DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24176879 ↗
• MalfunctionDec 29, 2025Inflation Problem; Compatibility Problem; Inflation Problem; Compatibility Problem

  IT WAS REPORTED A VERTEBROPLASTY(L4) WAS PERFORMED ON (B)(6) 2025. THE PROCEDURE WAS PERFORMED ACCORDING TO THE PROCEDURE MANUAL AND THE BALLOON WAS INFLATED. WHEN ATTEMPTING TO EXTRACT THE BALLOON FOR CEMENT INJECTION, THE BALLOON WAS DIFFICULT TO REMOVE FROM THE OUTER TUBE, AND THE SHAFT EVENTUALLY CAME OUT STRETCHED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23913563 ↗
• MalfunctionDec 29, 2025Inflation Problem; Compatibility Problem; Inflation Problem; Compatibility Problem

  IT WAS REPORTED A VERTEBROPLASTY(L4) WAS PERFORMED ON (B)(6) 2025. THE PROCEDURE WAS PERFORMED ACCORDING TO THE PROCEDURE MANUAL AND THE BALLOON WAS INFLATED. WHEN ATTEMPTING TO EXTRACT THE BALLOON FOR CEMENT INJECTION, THE BALLOON WAS DIFFICULT TO REMOVE FROM THE OUTER TUBE, AND THE SHAFT EVENTUALLY CAME OUTSTRETCHED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23913415 ↗
• MalfunctionDec 4, 2025Inflation Problem; Compatibility Problem; Inflation Problem; Compatibility Problem

  IT WAS REPORTED THAT THIS WAS A VERTEBROPLASTY (TH12) PERFORMED ON (B)(6) 2025. THE BALLOON WAS INFLATED ACCORDING TO THE PROCEDURE, BUT WHEN THE SURGEON TRIED TO REMOVE IT, IT WOULDN'T COME OUT. IN THE END, THE SURGEON REMOVED THE WORKING SLEEVE AND THEN THE BALLOON WAS ABLE TO REMOVE, SO THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30MINS OF DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720243 ↗
• MalfunctionNov 5, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS VERTEBROPLASTY(TH12) PERFORMED ON (B)(6) 2025. DURING SURGERY, WHEN ATTEMPTING TO INSERT THE BALLOON INTO THE BODY, THE BALLOON WOULD NOT PASS THROUGH THE NEEDLE. THE SURGEON TRIED REMOVING THE AIR AGAIN BUT WERE UNABLE TO INSERT THE BALLOON. WHEN THE SURGEON CHECKED THE BALLOON ITSELF, IT WAS FLATTENED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478917 ↗
• MalfunctionSep 3, 2025Inflation Problem; Activation, Positioning or Separation Problem; Inflation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2025. DURING SURGERY, THE SURGEON ATTEMPTED TO APPLY NEGATIVE PRESSURE TO THE SYNFLATE BALLOON AND INSERT IT THROUGH THE SLEEVE BUT WAS UNABLE TO DO SO EASILY. THE SURGEON THEN MANAGED TO INSERT THE SYNFLATE BALLOON, BUT THIS TIME IT WAS DIFFICULT TO REMOVE, SO HE REMOVED IT ALONG WITH THE SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22951493 ↗
• MalfunctionSep 3, 2025Inflation Problem; Activation, Positioning or Separation Problem; Inflation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2025. DURING SURGERY, THE SURGEON ATTEMPTED TO APPLY NEGATIVE PRESSURE TO THE SYNFLATE BALLOON AND INSERT IT THROUGH THE SLEEVE BUT WAS UNABLE TO DO SO EASILY. THE SURGEON THEN MANAGED TO INSERT THE SYNFLATE BALLOON, BUT THIS TIME IT WAS DIFFICULT TO REMOVE, SO HE REMOVED IT ALONG WITH THE SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22951323 ↗
• MalfunctionAug 26, 2025Inflation Problem; Compatibility Problem; Inflation Problem; Compatibility Problem

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS VERTEBROPLASTY PERFORMED ON (B)(6) 2025. DURING SURGERY, IT WAS DIFFICULT TO REMOVE THE BALLOON. THEREFORE, THE SURGEON REMOVED THE ENTIRE BALLOON'S OUTER TUBE AND CUT THE BALLOON WITH SCISSORS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893411 ↗
• MalfunctionAug 21, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2025. DURING SURGERY, THE SURGEON ATTEMPTED TO PASS THE BALLOON AFTER THE NEGATIVE PRESSURE THROUGH THE ACCESS NEEDLE BUT WAS UNABLE TO DO SO. THE SURGEON WAS ABLE TO GET THROUGH IT BY APPLYING NEGATIVE PRESSURE AGAIN AND SLIGHTLY ADJUSTING THE SHAPE WITH THE BALLOON COVER. THE SURGEON HAD PERFORMED MANY SURGERIES, BUT THIS WAS THE FIRST TIME THIS HAD HAPPENED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22865610 ↗
• MalfunctionAug 21, 2025Inflation Problem; Compatibility Problem; Inflation Problem; Compatibility Problem

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6)., 2025. IN THE SURGERY, THE USUAL PREPARATION WAS PERFORMED, BUT THE BALLOON COLLAPSED AND COULD NOT BE PASSED THROUGH THE WORKING SLEEVE. THEREFORE, THE SURGEON COMPLETED THE OPERATION BY INJECTING CEMENT WITHOUT INFLATING THE BALLOON INSIDE THE VERTEBRAL BODY. OF THE TWO PRODUCTS USED ON THE LEFT AND RIGHT SIDES, THE HOSPITAL AND DISTRIBUTOR WERE UNABLE TO CONFIRM WHICH LOT WAS DEFECTIVE AND DISCARDED THE PRODUCTS. IT WAS POSSIBLE THAT THE LOT IN QUESTION (LOT# 82326040) WAS DEFECTIVE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22865044 ↗
• MalfunctionAug 21, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2025. IN THE SURGERY, THE USUAL PREPARATION WAS PERFORMED, BUT THE BALLOON COLLAPSED AND COULD NOT BE PASSED THROUGH THE WORKING SLEEVE. THEREFORE, THE SURGEON COMPLETED THE OPERATION BY INJECTING CEMENT WITHOUT INFLATING THE BALLOON INSIDE THE VERTEBRAL BODY. OF THE TWO PRODUCTS USED ON THE LEFT AND RIGHT SIDES, THE HOSPITAL AND DISTRIBUTOR WERE UNABLE TO CONFIRM WHICH LOT WAS DEFECTIVE AND DISCARDED THE PRODUCTS. IT WAS POSSIBLE THAT THE LOT IN QUESTION (LOT# 82336835) WAS DEFECTIVE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22860956 ↗
• MalfunctionAug 19, 2025Inflation Problem; Compatibility Problem; Inflation Problem; Compatibility Problem

  THE SYNFLATE BALLOON COULD NOT BE COMPLETELY VENTILATED AFTER THE DILATION AND NO LONGER FIT THROUGH THE WORKING SLEEVE. THIS WORKING SLEEVE HAD TO BE PULLED TOGETHER WITH THE BALLOON. A NEW WORKING SLEEVE HAD TO BE INSERTED. THIS DELAYED THE OPERATION. THE PATIENT WAS NOT HURT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22842972 ↗
• MalfunctionJul 16, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2025. IN THE SURGERY, IT WAS CONFIRMED THAT TWO BALLOONS WERE BROKEN. THE SALES REPRESENTATIVE WAS NOT PRESENT DURING THE SURGERY, SO DETAILS SUCH AS THE INSTALLATION PROCEDURES OF THE BALLOON AND INFLATION SYSTEM AND CONDITIONS WERE UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22525750 ↗
• MalfunctionJul 16, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2025. IN THE SURGERY, IT WAS CONFIRMED THAT TWO BALLOONS WERE BROKEN. THE SALES REPRESENTATIVE WAS NOT PRESENT DURING THE SURGERY, SO DETAILS SUCH AS THE INSTALLATION PROCEDURES OF THE BALLOON AND INFLATION SYSTEM AND CONDITIONS WERE UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22525710 ↗
• MalfunctionJun 16, 2025Inflation Problem; Compatibility Problem; Inflation Problem; Compatibility Problem

  IT WAS REPORTED THAT THIS WAS A BKP FOR COMPRESSION FRACTURE ON (B)(6) 2025. DURING SURGERY, AFTER THE SURGEON INFLATED AND DEFLATED THE BALLOON, HE ATTEMPTED TO PULL IT OUT, BUT THE BALLOON GOT CAUGHT ON THE WORKING SLEEVE AND COULD NOT BE REMOVED. THEREFORE, THE SURGEON REMOVED THE ENTIRE WORKING SLEEVE, REMOVED THE BALLOON, AND THEN REINSTALLED THE WORKING SLEEVE. THEN THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. THE BALLOON WAS DISCARDED AT THE HOSPITAL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22215841 ↗
• MalfunctionJun 16, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS VERTEBROPLASTY PERFORMED ON MAY 22, 2025. IN THE SURGERY, WHEN THE SURGEON WAS INFLATING THE LEFT 2CC TO INFLATE THE SYNFLATE BALLOON, THE BALLOON BROKE. SUBSEQUENTLY, WHEN THE RIGHT 4CC SIDE OF THE SYNFLATE BALLOON WAS INFLATED, IT ALSO BROKE. THE BROKEN SYNFLATE BALLOONS WERE RETRIEVED, CEMENT WAS INJECTED, AND THE SURGERY WAS COMPLETED. THE PREPARATION AND TECHNIQUE WAS AS USUAL.THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22213074 ↗
• MalfunctionJun 16, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS VERTEBROPLASTY PERFORMED ON (B)(6) 2025. IN THE SURGERY, WHEN THE SURGEON WAS INFLATING THE LEFT 2CC TO INFLATE THE SYNFLATE BALLOON, THE BALLOON BROKE. SUBSEQUENTLY, WHEN THE RIGHT 4CC SIDE OF THE SYNFLATE BALLOON WAS INFLATED, IT ALSO BROKE. THE BROKEN SYNFLATE BALLOONS WERE RETRIEVED, CEMENT WAS INJECTED, AND THE SURGERY WAS COMPLETED. THE PREPARATION AND TECHNIQUE WAS AS USUAL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22213044 ↗