Spacemaker Plus SMSBTOVLRecalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 10884521067820), received between Nov 7, 2016 and Mar 31, 2022 — classified as 2 injuries, 57 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (30 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 59 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2022Difficult to Insert; Material Deformation; Packaging Problem; Difficult to Insert; Material Deformation; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA PROCEDURE, WHILE INSERTING THE BALLOON, THE BALLOON WAS DIFFICULT TO INSERT INTO THE PATIENT. THE SURGEON EXTENDED THE INCISION FOR LESS THAN AN INCH AND INSERTED THE DEVICE WITH FORCE TO RESOLVE THE ISSUE. THIS RESULTED TO THE PATIENT HAVING A TISSUE DAMAGE, PERMANENT LARGER SCAR. A PROBLEM WITH THE INNER PACKAGING OF THE DEVICE WAS ALSO NOTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13966236 ↗
• MalfunctionMar 11, 2021Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTAL EXTRA PERITONEAL INGUINAL HERNIA, ON THE ABDOMINAL INGUINAL CAVITY, THE RUBBER VALVE SEAL WAS DAMAGED AND WAS BROKEN IN THE SHAFT. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11467831 ↗
• MalfunctionMar 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHILE PERFORMING LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE BALLOON DISENGAGED FROM THE TROCAR/SLEEVE DURING INSUFFLATION. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11404383 ↗
• MalfunctionFeb 8, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING INSUFFLATION IN A LAPAROSCOPIC HERNIA REPAIR, THE BALLOON BURST AND SOME FRAGMENTS WERE DISENGAGED INTO THE PATIENT'S CAVITY. SURGEON WAS ABLE TO RETRIEVE THE FRAGMENTS. SURGEON HAD TO TAKE THE ENTIRE PORT OUT OF THE PATIENT AND RETRIEVE THE LARGE PIECE OF BALLOON PLASTIC FROM THE PATIENT PORT HOLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11293602 ↗
• MalfunctionDec 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AT THE BEGINNING OF THE AN INGUINAL HERNIA REPAIR, THE BALLOON DISENGAGED FROM THE TROCAR AND FELL INTO THE PATIENT'S CAVITY BUT THEN RETRIEVED WITHOUT PROBLEM. THE SPACE HAD TO BE CREATED MANUALLY. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10975256 ↗
• MalfunctionDec 9, 2020Inflation Problem; Product Quality Problem; Inflation Problem; Product Quality Problem

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC INGUINAL HERNIA REPAIR, WHILE IN THE ABDOMEN, THE BALLOON DID NOT INFLATE. THE TOTAL OPENING OF THE BALLOON DID NOT OCCUR DUE TO THE FORMATION OF RING IN THE MIDDLE OF THE BALLOON. THE SURGERY WAS COMPLETED WITHOUT THE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10974808 ↗
• MalfunctionNov 9, 2020Break; Inflation Problem; Break; Inflation Problem

  ACCORDING TO THE REPORTER, DURING INITIAL ACCESS ON A LAPAROSCOPIC VENTRAL HERNIA REPAIR, THE BALLOON WOULD NOT PROPERLY INFLATE AND BURST. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10813860 ↗
• MalfunctionJul 29, 2020Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE BALLOON DID NOT INFLATE.

  Patient problems: No Information

  MAUDE report 10341646 ↗
• MalfunctionJun 15, 2020Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, WHEN TRYING TO INFLATE THE DISSECTION BALLOON DURING A LAPAROSCOPIC HERNIA REPAIR, THE BALLOON WAS DIFFICULT TO INFLATE COMPLETELY. THE SURGEON STATED THAT THE VALVE WAS PROPERLY FIXATED TO THE PLASTIC, WHICH CAUSED TO HAVE A LEAK. THE BALLOON WAS CONTINUED TO INFLATE TO CREATE THE SPACE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10153051 ↗
• MalfunctionMay 19, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC INGUINAL HERNIA REPAIR, WHILE USING THE BALLOON FOR DISSECTION, THE BALLOON BROKE INSIDE THE ABDOMEN. THE SURGEON FISHED OUT THE PIECES OF PLASTIC FROM THE BROKEN BALLOON OUT OF THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10071655 ↗
• MalfunctionFeb 3, 2020Device Misassembled During Manufacturing /Shipping

  A SPACEMAKER PLUS DISSECTOR SYSTEM WAS OPENED AND IT WAS DISCOVERED THAT THE SEAL ON THE DISSECTOR BALLOON WAS OPEN, CAUSING IT TO FALL OFF THE APPARATUS. ANOTHER PRODUCT OF SAME TYPE WAS BROUGHT INTO THE OR AND PERFORMED AS EXPECTED. THERE WAS NO HARM TO THE PATIENT AND NO DELAY IN PROCEDURE. MANUFACTURER RESPONSE FOR LAPAROSCOPE, GENERAL PLASTIC SURGERY, SPACEMAKER PLUS (PER SITE REPORTER). THE DEVICE WILL BE RETURNED FOR FAILURE ANALYSIS.

  Patient problems: No Patient Involvement

  MAUDE report 9659263 ↗
• MalfunctionJan 30, 2020Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE BALLOON END WAS NOT INFLATING INSIDE THE ABDOMINAL CAVITY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9646879 ↗
• MalfunctionJan 10, 2020Inflation Problem

  SPACEMAKER PLUS DISSECTOR SYSTEM WAS FAULTY DURING PROCEDURE. THE BALLOON END WAS NOT INFLATING INSIDE THE ABDOMINAL CAVITY. A NEW DEVICE WAS OPENED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO HARM CAME TO THE PATIENT. MANUFACTURER RESPONSE FOR LAPAROSCOPE, GENERAL PLASTIC SURGERY, SPACEMAKER PLUS (PER SITE REPORTER). INFORMATION WAS SENT TO QUALITY AND FIELD REP. AWAITING REPLY AND RETURN KIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9575249 ↗
• MalfunctionJan 6, 2020Deflation Problem; Inflation Problem; Leak/Splash; Detachment of Device or Device Component; Packaging Problem; Material Split, Cut or Torn; Deflation Problem; Inflation Problem; Leak/Splash; Detachment of Device or Device Component; Packaging Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS BEING IN THE ABDOMINAL DURING A LAPAROSCOPIC RIGHT INGUINAL HERNIA, THERE WAS A HOLE IN THE BALLOON. IT WAS ALSO STATED THAT VALVE SEAL WAS DAMAGED AND DISENGAGED AND THE BALLOON WOULD NOT INFLATE AND INSUFFLATE. IT WAS ALSO STATED THAT BALLOON LEAKED GAS OR AIR. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9551236 ↗
• MalfunctionDec 26, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING LEFT INGUINAL HERNIA SURGERY, THE BALLOON DID NOT INFLATE DURING SURGERY. ANOTHER BALLOON WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9519712 ↗
• MalfunctionDec 6, 2019Inflation Problem; Leak/Splash; Human-Device Interface Problem; Inflation Problem; Leak/Splash; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC INGUINAL HERNIA, DURING DISSECTION AND INFLATION OF THE BALLOON, BALLOON CAN'T BE INFLATED FOR AIR STARTED TO LEAK OUT OF THE TROCAR WHERE THE SCOPE GOES INTO THE TROCAR. SURGEON USED A LAPAROSCOPIC SPONGE TO STOP THE AIR FROM LEAKING OUT NEAR THE SCOPE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9429630 ↗
• MalfunctionNov 25, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE BALLOON BROKE. IT WAS NOTED THAT THE PATIENT WAS UNDER ANESTHESIA LONGER THAN THEY WOULD HAVE BEEN DUE TO THE PRODUCT MALFUNCTION.

  Patient problems: No Information

  MAUDE report 9371681 ↗
• MalfunctionNov 15, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA REPAIR, THE DISSECTION BALLOON PART OF THE DEVICE WORKED PROPERLY AND THE STRUCTURAL BALLOON WOULD NOT INFLATE, A NEW BALLOON WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9328140 ↗
• MalfunctionOct 1, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC INGUINAL PROCEDURE, THE DEVICE BALLOON WAS PHYSICALLY BROKE. A NEW DEVICE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9142904 ↗
• MalfunctionOct 1, 2019Deflation Problem; Inflation Problem; Gas/Air Leak; Noise, Audible; Material Split, Cut or Torn; Deflation Problem; Inflation Problem; Gas/Air Leak; Noise, Audible; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA REPAIR, DURING BALLOON DISSECTION, THE DEVICE COULD NOT GET OPTIMUM OPERATING SPACE DUE TO PRODUCT ISSUE. THE BALLOON MADE STRANGE NOISE AND WOULD NOT INFLATE. BALLOON DEFLATED AND LEAKED GAS/AIR FOR THERE WAS A HOLE IN THE BALLOON. SURGEON WORKED AROUND ISSUE WITH LIMITED SPACE. PROCEDURE CONTINUED. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9142900 ↗
• MalfunctionSep 30, 2019Inflation Problem; Human-Device Interface Problem; Noise, Audible; Inflation Problem; Human-Device Interface Problem; Noise, Audible

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC INGUINAL HERNIA PROCEDURE, THE 3 DEVICES MADE STRANGE NOISE, DID NOT INFLATE, AND DID NOT INSUFFLATE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9137889 ↗
• MalfunctionSep 27, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL PROCEDURE, THE BALLOON DID NOT INFLATE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9128946 ↗
• MalfunctionSep 26, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, WHEN THE BALLOON WAS INSERTED INTO THE ABDOMEN DURING A LAPAROSCOPIC BILATERAL INGUINAL HERNIA, THE BALLOON DID NOT INFLATE. IT WAS STATED THAT THE SURGEON FELT SOMETHING CHANGED WITH THE BALLOON AND FELT THE QUALITY OF THE BALLOON HAS REDUCED. THE BALLOON NEVER INFLATED NO MATTER HOW MANY TIMES THEY PUMPED AIR INTO THE BULB. A SECOND BALLOON WAS OPENED AND THE SAME ISSUE OCCURRED. A THIRD BALLOON WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9124343 ↗
• MalfunctionAug 29, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC TOTAL EXTRAPERITONEAL SURGERY, THE BALLOON DIDN'T INSUFFLATE GOOD ENOUGH. IT INSUFFLATED A LITTLE BIT, BUT NOT TO FULL SHAPE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8945296 ↗
• MalfunctionAug 2, 2019Break; Break

  ACCORDING TO THE REPORTER, THREE DEVICES WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8855088 ↗