SYNFLATE 03.804.702SRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705034722726), received between Mar 2, 2018 and Aug 15, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2025Inflation Problem; Compatibility Problem; Inflation Problem; Compatibility Problem

  IT WAS REPORTED THAT THIS WAS A SPINAL FUSION (L1) FOR SPINAL CANAL STENOSIS ON (B)(6) 2025. IN THE SURGERY, THE SURGEON INFLATED THE BALLOON TO 6.0 CC AND THEN DEFLATED IT. AFTER MIXING THE CEMENT, THE SURGEON ATTEMPTED TO REMOVE THE BALLOON, BUT IT SEEMED TO GET CAUGHT ON THE TIP OF THE WORKING SLEEVE AND COULD NOT BE PULLED OUT. REPEATED DILATION AND DEFLATION PROCEDURES WERE PERFORMED, BUT THE BALLOON COULD NOT BE REMOVED. THE WORKING SLEEVE WAS REMOVED, THE BALLOON CATHETER WAS CUT, AND THE WORKING SLEEVE WAS REINSTALLED AND FILLED WITH CEMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22819577 ↗
• MalfunctionJul 21, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THIS WAS A PERCUTANEOUS VERTEBROPLASTY(LUMBER) FOR VERTEBRAL FRACTURE ON (B)(6) 2025. THE BALLOON HAD A LARGE HOLE IN THE SHAFT AND WAS THEREFORE IN NO CONDITION TO BE USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22561653 ↗
• MalfunctionMar 11, 2024Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024 A PERCUTANEOUS VERTEBROPLASTY WAS PERFORMED. DURING THE PROCEDURE, AFTER INFLATING AND DEFLATING THE BALLOON IN QUESTION, THE BALLOON WAS STUCK WHEN IT WAS ATTEMPTED TO BE REMOVED. THE BALLOON WAS RE-DILATED AND OTHER ATTEMPTS WERE MADE TO PULL IT OUT, BUT THE BALLOON REMAINED STUCK. THE SURGEON ULTIMATELY DECIDED TO PULL THE BALLOON OUT WITH FORCE, AND THE BALLOON BROKE WHEN IT WAS REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH UNDER 30 MINUTES OF SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SYNFLATE BALLOON/LARGE- STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18874195 ↗
• MalfunctionJan 17, 2024Inflation Problem; Compatibility Problem; Inflation Problem; Compatibility Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 A PERCUTANEOUS VERTEBROPLASTY WAS BEING PERFORMED. DURING THE PROCEDURE, THE SURGEON DILATED THE BALLOON ACCORDING TO THE PROCEDURE. WHEN ATTEMPTING TO REMOVE THE BALLOON UNDER NEGATIVE PRESSURE, THE BALLOON WAS CAUGHT IN THE WORKING SLEEVE AND COULD NOT BE REMOVED. APPLYING NEGATIVE PRESSURE AGAIN DID NOT RESOLVE THE SNAGGING, SO THE ENTIRE WORKING SLEEVE WAS REMOVED. WHEN THE BALLOON WAS CHECKED OUTSIDE OF THE BODY, THE TIP APPEARED TO BE SLIGHTLY INFLATED, CAUSING THE SNAGGING. THE BALLOON SHAFT WAS CUT AND REMOVED FROM THE WORKING SLEEVE. THE WORKING SLEEVE WAS THEN REINSERTED AND THE SURGERY CONTINUED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SYNFLATE BALLOON/LARGE- STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18524906 ↗
• MalfunctionNov 21, 2022Compatibility Problem; Material Integrity Problem; Compatibility Problem; Material Integrity Problem

  IT WAS FURTHER REPORTED THAT PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15835527 ↗
• MalfunctionJul 8, 2022Inflation Problem; Inflation Problem

  DEVICE REPORT FROM SWITZERLAND REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A KYPHOPLASTY ON L5 PROCEDURE ON (B)(6) 2022, THE SYNFLATE LARGE ON THE RIGHT SIDE OF THE VERTEBRA DID NOT EXPAND AS WISHED. THE SYNFLATE LARGE WAS REMOVED AND THE DIRECTION OF THE WORKING CANULA CHANGED. THE SYNFLATE LARGE WAS PREPARED AGAIN AND THE SURGEON TRIED TO ENTER IT THROUGH THE WORKING CANULA. THE SURGEON WAS NOT ABLE TO PUSH THE BALLOON THROUGH THE WHOLE CANULA. A NEW BALLOON HAD TO BE OPENED TO FINISH SURGERY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF TEN MINUTES. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A SYNFLATE BALLOON/LARGE- STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14957125 ↗
• MalfunctionApr 25, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A SURGEON PERFORMED A THREE-LEVEL KYPHOPLASTY WITH FOUR SYNFLATE BALLOONS AND THREE OF THEM BROKE. THERE WAS NO PATIENT CONSEQUENCE AND THE SURGERY WAS COMPLETED. THIS REPORT IS FOR THE 3RD OF THREE SYNFLATE BALLOONS. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14196500 ↗
• MalfunctionApr 25, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A SURGEON PERFORMED A THREE-LEVEL KYPHOPLASTY WITH FOUR SYNFLATE BALLOONS AND THREE OF THEM BROKE. THERE WAS NO PATIENT CONSEQUENCE AND THE SURGERY WAS COMPLETED. THIS REPORT IS FOR THE 1ST OF THREE SYNFLATE BALLOONS. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14196498 ↗
• MalfunctionApr 25, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A SURGEON PERFORMED A THREE-LEVEL KYPHOPLASTY WITH FOUR SYNFLATE BALLOONS AND THREE OF THEM BROKE. THERE WAS NO PATIENT CONSEQUENCE AND THE SURGERY WAS COMPLETED. THIS REPORT IS FOR THE 2ND OF THREE SYNFLATE BALLOONS. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14196469 ↗
• InjuryMar 2, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT A VERTEBRAL BODY PROCEDURE. DURING THE PROCEDURE, THE SYNFLATE BALLOON MALFUNCTIONED. THE SURGEON PLACED THE SYNFLATE BALLOON INTO THE VERTEBRAL BODY THROUGH THE PEDICLE, INFLATED THE BALLOON, THEN DEFLATED THE BALLOON UNTIL THE BUBBLES STOPPED COMING. HE TRIED TO PULL OUT THE BALLOON AND FELT RESISTANCE AND STOPPED. TRIED AGAIN AND FELT RESISTANCE THEN STOPPED, AND THEN ROTATED THE BALLOON. SURGEON WAS ABLE TO PULL OUT THE BALLOON. AT THIS POINT THE SURGEON PUT THE SYNFLATE BALLOON ON THE SCRUB TABLE AND NOTICED THAT 20 % OF THE BALLOON WAS LEFT IN THE PATIENT. NO HARM WAS DONE TO THE PATIENT AND THE SURGEON WAS ABLE TO FILL THE VOID IN THE VERTEBRAL BODY WITH CEMENT. PATIENT AND SURGERY OUTCOME WERE NOT REPORTED. CONCOMITANT DEVICES REPORTED: BALLOON INFLATION SYSTEM (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY:1). THIS REPORT IS FOR ONE (1) SYNFLATE BALLOON/LARGE- STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7310702 ↗