PDBRecalls & reported problems across all models
Covidien LP · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,114
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls
- 0
We found 2 models of PDB by Covidien LP in the FDA's device registry (GUDID). Together they are named in 1,114 adverse event reports in the FDA's MAUDE database, received between Nov 7, 2016 and Sep 29, 2026 — classified as 14 injuries, 1,100 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (658 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 PDB problems
Device problems
- Inflation Problem658
- Break473
- Detachment of Device or Device Component152
- Gas/Air Leak42
- Material Split, Cut or Torn38
- Leak/Splash27
- Detachment Of Device Component21
- Noise, Audible15
Patient problems
- No Clinical Signs, Symptoms or Conditions708
- No Known Impact Or Consequence To Patient203
- No Consequences Or Impact To Patient146
- Insufficient Information50
- No Code Available10
- No Patient Involvement10
- No Information9
- Foreign Body In Patient5
PDB models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PDB OMS-PDB1000Laparoscope, general & plastic surgery859 reports
- PDB OMS-PDBS2Powered laser surgical instrument255 reports
Recent PDB adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Break; Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935670 ↗MalfunctionSep 29, 2026Break; Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935648 ↗MalfunctionSep 28, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926358 ↗MalfunctionSep 21, 2026Inflation Problem; Gas/Air Leak
It was reported that during a TEP (totally extraperitoneal) hernioplasty, the balloon did not inflate and leaked gas/air. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50839509 ↗MalfunctionSep 17, 2026Break; Inflation Problem
It was reported that during a TEP hernioplasty, the balloon did not inflate. Upon examination, it was observed that the balloon had a hole and was physically broken. Their was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802549 ↗MalfunctionSep 16, 2026Difficult to Insert; Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794327 ↗MalfunctionSep 15, 2026Inflation Problem
According to the reporter during the totally extraperitoneal hernioplasty, balloon did not inflate. A new balloon was used to resolve the issue. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50766588 ↗MalfunctionSep 15, 2026Break
According to the reporter, during the laparoscopic totally extraperitoneal hernia repair, the device was being used in the preperitoneal space when the balloon physically broke and deflated. The balloon ruptured after approximately 5 to 10 inflations. It was removed without difficulty and replaced with a new balloon, which functioned normally and allowed the procedure to be completed. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50766509 ↗MalfunctionAug 18, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50311665 ↗MalfunctionAug 11, 2026Break; Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50216962 ↗MalfunctionAug 10, 2026Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50194058 ↗MalfunctionAug 5, 2026Break; Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50138614 ↗MalfunctionAug 4, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50131739 ↗MalfunctionJul 29, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50065754 ↗MalfunctionJul 29, 2026Break; Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50065642 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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