InSpace™ 0131Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 17290013396058), received between Jun 22, 2022 and Jul 7, 2026 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERSISTENT WEAKNESS OF LEFT ROTATOR CUFF, PAIN OF LEFT SHOULDER, AND ¿HARD BUMP¿ FELT IN LEFT SHOULDER AFTER APPROXIMATELY 3 MONTHS. PATIENT REQUIRED RE-ADMISSION TO HOSPITAL, MEDICAL CLEARANCE AND PROCEDURE TO REMOVE IMPLANT.

  Patient problems: Pain

  MAUDE report 25742100 ↗
• InjuryJun 23, 2026Material Fragmentation

  IT WAS REPORTED THAT THE DOCTOR USED AN INSPACE BALLOON AND THE SURGERY AND PROCEDURE WENT SMOOTHLY WITH NO ISSUES. THE DOCTOR THEN INFORMED ME HE RECEIVED POST-OP X RAYS, SHOWING THE INSPACE SMALL METAL INSERTER PIECE WAS LEFT BEHIND IN THE SHOULDER JOINT.

  Patient problems: Foreign Body In Patient

  MAUDE report 25602123 ↗
• MalfunctionNov 10, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AFTER INSERTING THE RECOMMENDED AMOUNT OF SALINE INTO A SIZE MEDIUM INSPACE BALLOON, IT WAS NOTICED THAT THE METAL TIP OF THE INSERTER HAD BROKEN OFF INTO THE BALLOON. THE BALLOON WAS THEN REMOVED AND ANOTHER BALLOON WAS INSERTED IT WAS ALSO A SIZE MEDIUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23516135 ↗
• InjuryJun 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT 6 WEEKS AFTER THE PATIENT¿S SURGERY THE BALLOON SLID ANTERIORLY AND LATERAL. MRI WAS PERFORMED. DOCTOR PERFORMED A REVISION SURGERY ON (B)(6) AND THE BALLOON WAS COMPLETELY DEFLATED UPON SCOPING THE SHOULDER. WHEN THE BALLOON WAS REMOVED, THERE WAS A HUGE HOLE IN THE SIDE OF IT, INDICATING THAT IT HAD POPPED AT SOME POINT. THIS PROCEDURE WAS DONE ON TOP OF A REPAIR AND THE SUTURES WERE NOTICEABLY TORN WHEN WE WENT IN AS WELL. DURING THE 2ND PROCEDURE, THE DOCTOR PLACED A NEW LARGE BALLOON IN THE PATIENT WHICH WENT IN WITHOUT ISSUES. HE ALSO DID AN OPEN SUBPECTENODESIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22206834 ↗
• InjuryNov 6, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING LAST FOLLOW UP AFTER INSPACE IMPLANTATION, THE DOCTOR DISCOVERED THE PATIENT HAS AXILLARY NERVE PALSY. THE DOCTOR IS UNSURE IF THIS IS DUE TO THE BALLOON OR ANOTHER FACTOR. THE PATIENT ALSO RECEIVED A NECK INJECTION ABOUT 6 WEEKS AFTER THE SPACER, WHICH COULD HAVE DONE DAMAGE, BUT IT¿S UNCLEAR. THE PATIENT NOW HAS PSEUDO PARALYSIS OF THE SHOULDER.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 20616130 ↗
• InjuryAug 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INSPACE BALLOON IMPLANT SHIFTED POSTERIORLY IN THE SUBACROMIAL SPACE 2 WEEKS POST OP. THE BALLOON WAS DEFLATED UPON EXAMINATION PRIOR TO REMOVAL. THE BALLOON WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19968454 ↗
• InjuryJun 7, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT HAD A SUBCUTANEOUS DEVELOPMENT OF ¿COTTAGE CHEESE¿ TYPE CONSISTENCY AFTER SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 19486707 ↗
• InjuryJun 7, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT HAD A SUBCUTANEOUS DEVELOPMENT OF ¿COTTAGE CHEESE¿ TYPE CONSISTENCY.

  Patient problems: Unspecified Infection

  MAUDE report 19486602 ↗
• InjuryMay 3, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE INITIAL PROCEDURE HAD NO ISSUES AND WAS SUCCESSFUL AT THE TIME OF INSERTION. AT NO TIME WAS THERE ANY BELIEF THE PRODUCT WAS DAMAGED OR BROKEN AFTER INSERTION. THE PROCEDURE WAS FINISHED AND WENT WELL. ON LATER DATE, AFTER OPERATION, THE PATIENT FELL AND AGGRAVATED HIS SHOULDER. PATIENT HAD X-RAYS ON WHICH SHOWED ¿A NEW TINY MAN-MADE DENSITY PROJECTING BETWEEN THE ACROMION AND THE HUMERAL HEAD MEASURING 4 X 1 MM.¿ FURTHER X-RAYS ON THEN SHOWED ¿THERE IS A METALLIC CLIP IN THE SUBACROMIAL SPACE.¿ AN ULTRASOUND ALSO SHOWED ¿A SMALL AMOUNT OF FLUID IS IDENTIFIED IN BETWEEN THE ACROMION AND HEAD OF THE HUMERUS. MORE INFERIOR AND DEEPER, ALONG THE PROXIMAL/MEDIAL HUMERAL HEAD THERE IS A COLLECTION OF FLUID MEASURING 3.4 X 2.2 X 2.3 CM.¿ AN ADDITIONAL SURGERY WAS THEN COMPLETED BY THE SURGEON TO REMOVE THE INSPACE BALLOON WITH ¿BALLOON REMOVED INTACT WITHOUT FLUID WITH METAL FRAGMENT INSIDE IT.¿ ACCORDING TO THE SURGEON, THE TIP OF THE INFLATION CANNULA BROKE OFF IN THE NECK OF THE DEVICE. WITH THE INFLATION CANNULA NOT VISIBLE PRIOR TO THE DEPLOYMENT AND INFLATION OF THE DEVICE, STAFF DID NOT NOTICE A DIFFERENCE IN THE CANNULA.

  Patient problems: Foreign Body In Patient

  MAUDE report 19240164 ↗
• InjuryMar 22, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THERE WAS PATIENT PAIN THAT REQUIRED AN ADDITIONAL SURGERY TO REMOVE THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16591959 ↗
• InjuryJun 22, 2022Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AND REQUIRED A WASH OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 14778111 ↗