Spacemaker Plus SMBTTRNDRecalls & reported problems

Summary

The FDA's MAUDE database contains 211 adverse event reports that list this exact device (DI 10884521067578), received between Oct 18, 2016 and Jul 1, 2022 — classified as 3 injuries, 208 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (76 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 211 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEP) HERNIA REPAIR, DURING INSERTION OF THE DEVICE THROUGH THE TROCAR, THE BALLOON WERE DAMAGED. THE BALLOON WAS TORN OPEN DURING WELDING SEAM. THE BALLOON ALSO DISENGAGED FROM THE TROCAR OR SLEEVE. HENCE, THE DEVICE COULD NOT BE INFLATED. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14887787 ↗
• MalfunctionApr 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE PULLING OUT THE BALLOON, THE BALLOON CAME OFF AND WAS PLACED IN THE RETROPERITONEAL CAVITY. IT DID NOT LOOK LIKE IT GOT CAUGHT AND NO RESISTANCE WAS FELT. THE REMAINING BALLOON WAS PULLED OUT USING FORCEPS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13980479 ↗
• MalfunctionMar 8, 2022Inflation Problem; Material Split, Cut or Torn; Inflation Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA SURGERY, THE FIRST BALLOON WAS TORN AND DID NOT INSUFFLATE AND THE SECOND BALLOON HAD A HOLE AND DID NOT INFLATE. A NEW BALLOON WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 13693614 ↗
• MalfunctionMar 8, 2022Inflation Problem; Material Split, Cut or Torn; Inflation Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA SURGERY, THE FIRST BALLOON WAS TORN AND DID NOT INSUFFLATE AND THE SECOND BALLOON HAD A HOLE AND DID NOT INFLATE. A NEW BALLOON WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 13693514 ↗
• MalfunctionFeb 8, 2022Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE BALLOON DEFLATED.

  Patient problems: Insufficient Information

  MAUDE report 13485316 ↗
• MalfunctionFeb 3, 2022Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, THE BALLOON DID NOT INFLATE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446676 ↗
• MalfunctionJan 12, 2022Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE BALLOON OF THE ACCESS CANNULA IS FOUND TORN. A NEW PRODUCT WAS USED AND THE SURGERY WAS PERFORMED WITHOUT ANY PROBLEMS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13235889 ↗
• MalfunctionDec 30, 2021Break; Leak/Splash; Break; Leak/Splash

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, THE DEVICE BURST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13118077 ↗
• MalfunctionDec 29, 2021Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA PROCEDURE, WHILE EXPANDING THE ABDOMINAL CAVITY WITH THE BALLOON, THE DEVICE DID NOT INFLATE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13112501 ↗
• MalfunctionDec 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, THE SEAL DISENGAGED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13010065 ↗
• MalfunctionDec 10, 2021Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC PROSTATECTOMY PROCEDURE, WHILE INITIATING OF PROCEEDINGS, THERE WAS A HOLE IN THE BALLOON. THE BALLOON DID NOT INFLATE. THE DEVICE WAS REPLACED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12976109 ↗
• MalfunctionDec 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, THE BALLOON DISENGAGED FROM THE TROCAR OR SLEEVE. THE TROCAR'S SILICON TIP WAS OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12941739 ↗
• MalfunctionNov 17, 2021Break; Human-Device Interface Problem; Break; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE BALLOON PHYSICALLY BROKE, THE DEVICE WAS UNABLE TO INSUFFLATE. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY. IT WAS NOTED THAT A STAPLER WAS ALSO INCLUDED WITH AN UNSPECIFIED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12827525 ↗
• MalfunctionOct 26, 2021Break; Break

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE BALLOON BROKE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12701434 ↗
• MalfunctionOct 1, 2021Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO PROCEDURE, THE BALLOON WITH AN OBTURATOR WAS BROKEN. THE TIP OF THE OBTURATOR PIERCED THE BALLOON AND MADE A HOLE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12562057 ↗
• MalfunctionSep 24, 2021Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE TROCAR WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12526556 ↗
• MalfunctionSep 14, 2021Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO SURGERY, THE BALLOON WAS FOUND BURST AND PHYSICALLY BROKE BEFORE USE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12467393 ↗
• MalfunctionAug 9, 2021Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12293597 ↗
• MalfunctionAug 4, 2021Detachment of Device or Device Component; Gas/Air Leak; Detachment of Device or Device Component; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE'S BALLOON HAD AIR/GAS LEAK. THE RING WAS OUT, AND CO2 WAS LEAKING.

  Patient problems: Insufficient Information

  MAUDE report 12273742 ↗
• MalfunctionJul 30, 2021Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE BALLOON BROKE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12252897 ↗
• MalfunctionJul 25, 2021Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, PREOPERATIVE TO LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE BALLOON DID NOT INFLATE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12223007 ↗
• MalfunctionJul 25, 2021Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC NEPHRECTOMY, THERE WAS DIFFICULTY WITH TAKING OUT AND INSERTING THE SCOPE. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12222995 ↗
• MalfunctionJun 30, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE BALLOON PHYSICALLY BROKE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12092069 ↗
• MalfunctionJun 30, 2021Break; Break

  ACCORDING TO THE REPORTER, BEFORE A LAPAROSCOPIC PROCEDURE, THE BALLOON PHYSICALLY BROKE. ANOTHER ONE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12091886 ↗
• MalfunctionJun 29, 2021Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO PROCEDURE, THE BALLOON PHYSICALLY BROKE. IN ORDER TO FIX THE ISSUE A NEW INSTRUMENT WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12086588 ↗