1588 AIMRecalls & reported problems across all models
Stryker Corporation · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 112
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 0
We found 4 models of 1588 AIM by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 112 adverse event reports in the FDA's MAUDE database, received between Oct 17, 2018 and Sep 24, 2026 — classified as 6 injuries, 106 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (59 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 1588 AIM problems
Device problems
- Poor Quality Image59
- No Display/Image40
- Product Quality Problem7
- Erratic or Intermittent Display5
- Output Problem5
- Biocompatibility4
- Device Dislodged or Dislocated4
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions83
- No Known Impact Or Consequence To Patient37
- Insufficient Information15
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Electric Shock2
- No Code Available2
- Laceration(s)1
- Superficial (First Degree) Burn1
1588 AIM models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 1588 AIM 1588210105Laparoscope, general & plastic surgery40 reports
- 1588 AIM 1588010000Confocal optical imaging35 reports
- 1588 AIM 1588020122Confocal optical imaging26 reports
- 1588 AIM 1588610122Laparoscope, general & plastic surgery11 reports
Recent 1588 AIM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50888689 ↗InjuryJun 26, 2026No Display/Image
IT WAS REPORTED THAT THE VIEW ON THE CAMERA WAS NOT STARTING. WHEN THE DECISION TO CANCEL THE MEDICAL PROCEDURE WAS MADE, THE PATIENT HAD ALREADY RECEIVED ANESTHESIA AND INCISIONS HAD ALREADY BEEN MADE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25640873 ↗MalfunctionDec 4, 2024Poor Quality Image; Optical Problem; Poor Quality Image; Optical Problem
IT WAS REPORTED THAT THERE WAS POOR IMAGE QUALITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20845800 ↗MalfunctionSep 19, 2024No Display/Image; No Device Output; No Display/Image; No Device Output
IT WAS REPORTED THAT THERE WAS LOSS IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20260645 ↗MalfunctionMay 10, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS DARK OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19293330 ↗MalfunctionApr 11, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS DARK OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19091761 ↗MalfunctionApr 10, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19084722 ↗MalfunctionApr 3, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19038151 ↗MalfunctionMar 8, 2024Poor Quality Image; Output Problem; Poor Quality Image; Output Problem
IT WAS REPORTED THAT THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18870759 ↗MalfunctionMar 8, 2024No Device Output; No Device Output
IT WAS REPORTED THAT THERE WAS FULL LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18870648 ↗MalfunctionMar 6, 2024No Display/Image; No Device Output; No Display/Image; No Device Output
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18852907 ↗MalfunctionJan 25, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18584715 ↗MalfunctionJan 25, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS POOR IMAGE QUALITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18580221 ↗MalfunctionJan 4, 2024Fogging; Fogging
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18449482 ↗MalfunctionDec 6, 2023Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS POOR QUALITY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18279509 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 recalls
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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