CooperSurgical® DP-SDP001Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00888937027792), received between May 29, 2026 and Sep 30, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (10 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948063 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948062 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948060 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948059 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948058 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948057 ↗
• MalfunctionSep 30, 2026Electrical /Electronic Property Problem

  It was reported that during a DIEP Flap procedure, the Doppler Probe did not consistently emit quality audio feedback when attached to the patient. This probe did not meet the expected standard. It did not provide adequate audio feedback through the Doppler Monitor. No patient harm. 1216677-2026-00167 DP-SDP001 Swartz Probe (b)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948056 ↗
• MalfunctionSep 29, 2026No Device Output

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937642 ↗
• MalfunctionSep 28, 2026No Device Output

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917821 ↗
• MalfunctionSep 28, 2026No Device Output

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917820 ↗
• MalfunctionSep 28, 2026No Device Output

  It was reported that during a Tranmandibular resection, bilateral neck dessection, reconstruction with left radial freeflap, doppler probes were determined to be defective. New probe was opened to complete the surgery. No patient harm reported. (b)(4) DP-SDP001 Swartz Probe (b)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917819 ↗
• MalfunctionSep 28, 2026No Device Output

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917818 ↗
• MalfunctionSep 25, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903870 ↗
• MalfunctionSep 24, 2026No Device Output

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884811 ↗
• MalfunctionAug 27, 2026Electrical /Electronic Property Problem

  It was reported that the hospital is having issues with the probe performance. Hospital reported that they had discarded defective devices. Additional communication revealed that the issues they have been having are related to sound. They cannot hear the sound waves from the probe when applied to the vessel. No patient harm reported. No additional information is available. (b)(6)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50476908 ↗
• MalfunctionJun 17, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING A HEAD/NECK FLAP PROCEDURE, THE DOPPLER PROBE FAILED TO PRODUCE SOUND. A SECOND PROBE WAS OPENED AND USED. PROCEDURE COMPLETED SUCCESSFULLY. NO PATIENT HARM REPORTED; IMPACT LIMITED TO PROCEDURAL DELAY AND DEVICE REPLACEMENT INTRA-PROCEDURE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. . DP-SDP001 SWARTZ PROBE 2026-05-0000409.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25534770 ↗
• MalfunctionMay 29, 2026Product Quality Problem

  IT WAS REPORTED THAT DURING A DIEP FLAP PROCEDURE, THE PHYSICIAN PLACED A COOK DOPPLER PROBE IN THIS PATIENT. IT WAS ACCIDENTALLY BROKEN AND NEEDED TO BE REPLACED. SIX PROBES WERE OPENED, AND NONE OF THEM WERE FUNCTIONAL. THE PATIENT WAS TAKEN OUT OF THE OPERATING ROOM WITHOUT AN IMPLANTED DOPPLER PROBE. FLAP MONITORING IS BEING ACCOMPLISHED WITH A PENCIL DOPPLER, WHICH IS LESS THAN OPTIMAL AND NOT THE USUAL STANDARD OF CARE. 1216677-2026-00041 DP-SDP001 SWARTZ PROBE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334511 ↗
• MalfunctionMay 29, 2026Product Quality Problem

  IT WAS REPORTED THAT DURING A DIEP FLAP PROCEDURE, THE PHYSICIAN PLACED A COOK DOPPLER PROBE IN THIS PATIENT. IT WAS ACCIDENTALLY BROKEN AND NEEDED TO BE REPLACED. SIX PROBES WERE OPENED, AND NONE OF THEM WERE FUNCTIONAL. THE PATIENT WAS TAKEN OUT OF THE OPERATING ROOM WITHOUT AN IMPLANTED DOPPLER PROBE. FLAP MONITORING IS BEING ACCOMPLISHED WITH A PENCIL DOPPLER, WHICH IS LESS THAN OPTIMAL AND NOT THE USUAL STANDARD OF CARE. 1216677-2026-00042 DP-SDP001 SWARTZ PROBE 2026-05-0000369

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334497 ↗