PINPOINT PC9002Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00858701006551), received between Jun 19, 2019 and Aug 21, 2025 — classified as 1 death, 8 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (8 reports).

1 other recall cover devices cleared under the same FDA submission (K150956); they may or may not involve this specific model.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE IMAGE CUTS OUT WHEN CABLE IS MOVED. THEREFORE, THERE WAS LOSS OF IMAGE.

  Patient problems: Insufficient Information

  MAUDE report 22867698 ↗
• MalfunctionDec 19, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE DURING PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20982311 ↗
• MalfunctionMay 17, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE DURING PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19344920 ↗
• MalfunctionDec 6, 2023No Display/Image; No Display/Image

  IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE DURING PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18279449 ↗
• MalfunctionAug 29, 2022No Display/Image

  IT WAS REPORTED THAT THE DEVICE LOST IMAGE DURING A PROCEDURE, CAUSING A 5 MINUTE DELAY. THERE WERE NO REPORTED ADVERSE CONSEQUENCES AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15312221 ↗
• MalfunctionDec 7, 2020No Display/Image; Intermittent Loss of Power; No Display/Image; Intermittent Loss of Power

  IT WAS REPORTED THAT THERE WAS IMAGE LOSS DURING PROCEDURE. PLEASE NOTE THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10963112 ↗
• DeathSep 14, 2020Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT THERE WAS PATIENT DEATH. PLEASE NOTE THAT THERE IS NO ALLEGED DEFICIENCY WITH THE REPORTED DEVICES AND IT CANNOT BE DETERMINED AT THIS TIME, WHICH, IF ANY, OF THE REPORTED DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO PATIENT OUTCOME.

  Patient problems: Death; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10532262 ↗
• MalfunctionJul 22, 2020No Display/Image; Electrical Shorting; No Display/Image; Electrical Shorting

  IT WAS REPORTED THAT THERE WAS IMAGE LOSS & THERMAL EVENT DURING PROCEDURE. PLEASE NOTE THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTS OF ADVERSE CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10307922 ↗
• MalfunctionJun 19, 2019No Display/Image

  IT WAS REPORTED THAT THERE WAS IMAGE LOSS DURING PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTS OF ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8714593 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150956. One submission often covers many models, so check the product and lot details in each record.

• Z-1428-2021 · Feb 26, 2021 · Terminated
  Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UDI: (01) 00858701006049 - Product Usage: used with both the SPY-PHI and PINPOINT sys