SpacemakerRecalls & reported problems across all models
Covidien LP · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,210
- Deaths reported
- 0
- Injuries reported
- 33
- Recalls
- 0
We found 5 models of Spacemaker by Covidien LP in the FDA's device registry (GUDID). Together they are named in 1,210 adverse event reports in the FDA's MAUDE database, received between Jul 19, 2016 and Sep 30, 2026 — classified as 33 injuries, 1,177 malfunctions.
The most frequently reported specific device problem is “Break” (517 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Spacemaker problems
Device problems
- Break517
- Inflation Problem439
- Detachment of Device or Device Component178
- Packaging Problem139
- Leak/Splash77
- Gas/Air Leak70
- Material Split, Cut or Torn49
- Difficult to Insert41
Patient problems
- No Clinical Signs, Symptoms or Conditions698
- No Known Impact Or Consequence To Patient202
- No Consequences Or Impact To Patient184
- Insufficient Information99
- No Patient Involvement20
- Unspecified Tissue Injury20
- No Information14
- Hemorrhage/Blood Loss/Bleeding9
Spacemaker models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Spacemaker SMBTTRNDXLaparoscope, general & plastic surgery590 reports
- Spacemaker SMBTTOVLXLaparoscope, general & plastic surgery422 reports
- Spacemaker SMSBTOVLXLaparoscope, general & plastic surgery114 reports
- Spacemaker SMSBTRNDXLaparoscope, general & plastic surgery74 reports
- Spacemaker SMCYLCSTLaparoscope, general & plastic surgery10 reports
Recent Spacemaker adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955101 ↗MalfunctionSep 30, 2026Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952399 ↗MalfunctionSep 30, 2026Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951279 ↗MalfunctionSep 30, 2026Inflation Problem
It was reported during a laparoscopic procedure that two balloons did not inflate. A new product was used to resolve the issue. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947179 ↗MalfunctionSep 30, 2026Inflation Problem
It was reported during a laparoscopic procedure that two balloons did not inflate. A new product was used to resolve the issue. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946724 ↗MalfunctionSep 24, 2026Break
According to the reporter, intra-operatively of a laparoscopic inguinal hernia repair, during dissection, two balloons physically ruptured. Another device was used to resolve the issue. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876990 ↗MalfunctionSep 24, 2026Break
According to the reporter, intra-operatively of a laparoscopic inguinal hernia repair, during dissection, two balloons physically ruptured. Another device was used to resolve the issue. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876983 ↗MalfunctionSep 21, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846974 ↗MalfunctionSep 21, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846972 ↗MalfunctionSep 21, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846834 ↗MalfunctionSep 21, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50843081 ↗MalfunctionSep 21, 2026Break
According to the reporter, during a laparoscopic surgery, the balloon burst and could not be inflated. A new device was used to resolve the issue. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842769 ↗MalfunctionSep 16, 2026Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796534 ↗MalfunctionSep 16, 2026Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50788479 ↗MalfunctionSep 15, 2026Inflation Problem
According to the reporter, pre-operatively, the balloon did not inflate. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50769832 ↗
Other Covidien LP products
- Endo GIA48 models · 26,277 reports · 8 recalls
- Endo GIA Ultra3 models · 15,650 reports
- Shiley387 models · 9,392 reports · 5 recalls
- Signia16 models · 8,201 reports · 6 recalls
- LigaSure32 models · 7,283 reports · 1 recall
- Tri-Staple 2.037 models · 4,892 reports · 2 recalls
- Polysorb291 models · 4,564 reports · 2 recalls
- EEA39 models · 4,432 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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