Cook-Swartz G21363Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00827002213630), received between Nov 17, 2016 and May 15, 2025 — classified as 20 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (9 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2025No Audible Prompt/Feedback; Adverse Event Without Identified Device or Use Problem; No Audible Prompt/Feedback; Adverse Event Without Identified Device or Use Problem

  WHEN THE DOPPLER WAS BEING IMPLANTED INTO THE PATIENT ON (B)(6) 2025, WHEN CONNECTED TO THE DOPPLER MACHINE, THERE WAS A LOUD SQUEALING NOISE BUT THE DOPPLER READ APPROPRIATELY. ON (B)(6), THE DOPPLER STOPPED READING COMPLETELY AND THE PATIENT HAD TO BE BROUGHT BACK TO THE OPERATING ROOM TO GET THE DOPPLER EXCHANGED. IT SEEMED LIKE THE WIRES ON THE DOPPLER WERE TWISTED AND THAT'S WHY IT WASN'T WORKING PROPERLY.

  Patient problems: Failure of Implant

  MAUDE report 22027800 ↗
• InjuryMar 28, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS: GENTLE TRACTION WAS USED ON THE WIRE AT THE POINT OF ENTRY TO THE SKIN. THE LEFT BREAST PROBE WAS REMOVED WITHOUT INCIDENCE BUT THE ON THE RIGHT SIDE, IT APPEARS THAT ONE STRAND OF THE BRAIDED WIRE CAME OUT FULLY (BUT WITHOUT THE CRYSTAL PROBE) AND THE OTHER STRAND BROKE. EACH TIME THE BROKEN STRAND WAS GRABBED IT BROKE. XRAY DOES NOT SHOW THE WIRE. OBVIOUSLY THERE IS SIGNIFICANT RISK IN TRYING TO GO BACK AND REMOVE THE PROBE SURGICALLY. GIVEN, THE FINDINGS OF THE ARTICLE I HAVE INCLUDED, WHAT IS THE BASIS FOR THE COMPANY¿S RECOMMENDATION TO SURGICALLY REMOVE THE WIRE?

  Patient problems: Foreign Body In Patient

  MAUDE report 18990995 ↗
• InjuryOct 26, 2023Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  EXPLANTING THE DOPPLER PROBE RESULTED IN AN INCOMPLETE REMOVAL OF THE PROBE. THE REMOVED PART WAS DISPOSED, THE DISTAL PART OF THE PROBE LEFT IN SITU. IT IS NOT CLEAR YET WHETHER THE INCOMPLETE REMOVAL IS DUE TO CUTTING OR TEARING OFF. A MEETING WITH THE DR. TO COMPLETE THIS INFORMATION COULD NOT TAKE PLACE EARLIER, AND IS SCHEDULED ON 24TH OCTOBER. NONETHELESS WE WANTED TO PROVIDE YOU THIS INFORMATION ALREADY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18010747 ↗
• InjuryAug 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER REP - (B)(6) 2023 - THE CLIP THAT WAS SECURING THE DOPPLER TO THE VEIN SLIPPED DOWN THE VEIN AND OCCLUDED THE BLOOD SUPPLY. THE PATIENT ORIGINALLY HAD SURGERY ON (B)(6) 2023. THE PATIENT HAD TO RETURN TO THE O.R. ON (B)(6) 2023 DUE TO THE OCCLUDED BLOOD SUPPLY. THE CAUSE OF THE OCCLUDED VEIN WAS DETERMINED DURING THE RETURN TO THE O.R.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17486661 ↗
• InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON (B)(6) 2021 AFTER MONITORING HAD ENDED, AN UNEXPECTED EVENT OCCURRED DURING REMOVAL OF THE PROBE. THE CRYSTAL DID NOT DETACH AS NORMAL. THE WIRE BROKE AND REMAINED IN THE PATIENT'S BODY. ON (B)(6) 2022 A SURGEON PERFORMED AN ADDITIONAL OPERATION TO REMOVE THE CRYSTAL PROBE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL NORMALLY AND SMOOTHLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 13580118 ↗
• InjuryFeb 22, 2021Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  AS REPORTED TO CUSTOMER RELATIONS VIA COMPLAINT FORM "WE HAVE HAD MANY WIRES BREAK OFF WHEN PULLING THEM OUT OVER THE PAST FEW MONTHS. WE TYPICALLY PULL THE WIRES ON POD5-7 AND DID NOT HAVE ISSUES BUT RECENTLY, THEY ARE EXTREMELY HARD TO PULL OUT AND BREAK OFF PROXIMAL TO THE DOPPLER ITSELF. THIS LED TO A PRACTICE CHANGE THAT THE WIRE WOULD BE CUT WITH A TAIL EXTERNAL TO THE PATIENT AND PULLED OUT TWO WEEKS LATER IN CLINIC. THE HOSPITAL REQUIRED ANOTHER PRACTICE CHANGE AS THEY CONSIDERED THAT A RETAINED FOREIGN BODY. THEREFORE, MY PARTNER PULLED THIS ONE AND AGAIN, HAD SIGNIFICANT RESISTANCE AND THE WIRE BROKE. THIS CAUSED AN ARTERIAL INJURY ON AN OTHERWISE VIABLE FLAP ON POD 5-7. THE FLAP ULTIMATELY REQUIRED REVISION TWICE AND HAS NOW FAILED. THERE IS NO DOUBT IT WAS RELATED TO THE TRAUMA CAUSED BY THE WIRE."

  Patient problems: Perforation of Vessels

  MAUDE report 11359799 ↗
• MalfunctionFeb 9, 2021Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UNKNOWN PROCEDURE WHICH INVOLVED THE COOK-SWARTZ DOPPLER FLOW PROBE STANDARD CUFF (DP-SDP001), IN WHICH AN UNKNOWN PORTION OF WIRE BROKE OFF DURING ATTEMPTED REMOVAL OF THE DEVICE. THE MALFUNCTION WAS NOT OBVIOUS TO THE PROVIDER WHO REMOVED THE DEVICE. THE FRAGMENT OF WIRE REMAINING IN THE PATIENT WAS DISCOVERED SEVERAL DAYS LATER AND REMAINS IN THE PATIENT, BASED ON THE INFORMATION PROVIDED TO THE MANUFACTURER. THE FRAGMENT WAS LEFT IN PATIENT DUE TO RISK OF REMOVAL. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE USER FACILITY.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 11304624 ↗
• MalfunctionSep 5, 2018Detachment of Device or Device Component; Audible Prompt/Feedback Problem; Detachment of Device or Device Component; Audible Prompt/Feedback Problem

  AS PER REPORT ON (B)(6) 2018, A DOPPLER PROBE FAILED AND THE PATIENT HAD TO BE TAKEN BACK TO THE OPERATING ROOM FOR AN ADDITIONAL SURGERY.

  Patient problems: No Code Available

  MAUDE report 7847762 ↗
• MalfunctionApr 30, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  A DOPPLER CRYSTAL PREMATURELY SEPARATED FROM THE CUFF AND THE PATIENT HAD TO GO THROUGH AN ADDITIONAL PROCEDURE TO REPLACE THE DOPPLER.

  Patient problems: No Code Available

  MAUDE report 7472072 ↗
• MalfunctionMar 29, 2018Detachment Of Device Component; Detachment Of Device Component

  THE CRYSTAL DETACHED FROM THE CUFF TWO DAYS AFTER THE PATIENTS INITIAL SURGERY, WHEN THE DOPPLER WAS PLACED. THE PATIENT HAD TO RETURN TO THE OPERATING ROOM FOR A SECOND SURGERY TO REPLACE THE DEFECTIVE DOPPLER FLOW PROBE.

  Patient problems: No Code Available

  MAUDE report 7381334 ↗
• InjuryMar 12, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE DEVICE DETACHED FROM THE CUFF PREMATURELY, REQUIRING AN ADDITIONAL PROCEDURE TO REPLACE THE DEVICE. NO ADDITIONAL CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 7330226 ↗
• InjuryFeb 2, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A NECK FLAP SURGERY AND TWO DOPPLER PROBES WERE PLACED TO MONITOR BLOOD FLOW, ONE ON THE ARTERY AND ONE ON THE VEIN. THE SIGNAL FROM THE PROBES WAS LOST POST-OPERATIVELY AND THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM FOR AN ADDITIONAL SURGERY TO REPLACE THE PROBES. UPON RETRIEVAL OF THE INITIALLY PLACED PROBES, IT WAS DISCOVERED THERE WAS A LOOSE CONNECTION AT THE CUFF. NEW PROBES WERE PLACED SUCCESSFULLY AND NO ADDITIONAL CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 7236929 ↗
• InjuryJan 18, 2018Loss of or Failure to Bond; Detachment of Device or Device Component; Loss of or Failure to Bond; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DUE TO THE COOK-SWARTZ DOPPLER PROBE NOT WORKING CORRECTLY, THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM FOR A FREE-FLAP REVISION SURGERY. ONCE THE OPERATION STARTED, THE PHYSICIAN FOUND THAT THE CRYSTAL WAS DETACHED FROM THE PROBE. THIS ADDITIONAL PROCEDURE RESULTED IN A LONGER HOSPITAL STAY FOR THE PATIENT. NO OTHER PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 7203369 ↗
• MalfunctionDec 21, 2017Detachment Of Device Component; Defective Component; Detachment Of Device Component; Defective Component

  THE CUSTOMER REPORTED THAT, FOR A DEEP INFERIOR EPIGASTRIC PERFORATORS (DIEP) FLAP BREAST RECONSTRUCTION APPLICATION, THE PROBE WAS NOT GLUED WELL ENOUGH TO THE CUFF. AS A RESULT, THE DEVICE DID NOT WORK. NO OTHER INCIDENT INFORMATION WAS PROVIDED. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED; AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7138735 ↗
• MalfunctionDec 20, 2017Detachment Of Device Component; Disconnection; Detachment Of Device Component; Disconnection

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE COOK-SWARTZ DOPPLER PROBE CUFF PREMATURELY DISCONNECTED AFTER IT HAD ALREADY BEEN IMPLANTED IN THE PATIENT. THE DEVICE HAD TO BE REMOVED AND REPLACED WITH ANOTHER PROBE TO CORRECT THE CONDITION. THE CUSTOMER CONFIRMED THAT NO HARM CAME TO THE PATIENT, BUT IT WAS REPORTEDLY INCONVENIENT FOR THE STAFF INVOLVED. IT IS UNKNOWN IF THE PRODUCT WILL BE RETURNED; AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7133040 ↗
• InjuryDec 6, 2017Detachment Of Device Component; Material Separation; Detachment Of Device Component; Material Separation

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE COOK-SWARTZ DOPPLER PROBE CRYSTAL CAME OFF PREMATURELY AT THE END OF SURGERY. THE OPERATOR HAD TO REPLACE THE CRYSTAL AND RE-OPEN THE PATIENT'S NECK. THE CIRCUMSTANCES SURROUNDING THE USAGE AND HANDLING OF THE DEVICE LEADING UP TO THE PRODUCT MALFUNCTION WERE NOT REPORTED. THE DEVICE IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: No Code Available

  MAUDE report 7088265 ↗
• InjuryNov 21, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED TO CUSTOMER RELATIONS: "THE DOPPLER WAS INITIALLY WORKING WHEN PUT IN THE PATIENT, BUT CRYSTAL DETACHED/SLIPPED AFTER THE SURGERY WAS COMPLETE. THE PATIENT HAD TO GO BACK FOR A SECOND SURGERY IN ORDER TO REPLACE THE DOPPLER. THIS REQUIRED THE PATIENT TO UNDERGO A SECOND GENERAL ANESTHESIA, INCREASED THE RISK OF INFECTION, INCREASED THE RISK OF NEUROVASCULAR ISSUES AND DELAYED DISCHARGE FROM HOSPITAL.

  Patient problems: No Code Available

  MAUDE report 7048217 ↗
• InjuryNov 21, 2017Defective Component; Detachment of Device or Device Component; Defective Component; Detachment of Device or Device Component

  AS REPORTED TO CUSTOMER RELATIONS: "THE DOPPLER WAS INITIALLY WORKING WHEN IT WAS PUT INTO THE PATIENT, BUT THE CRYSTAL STOPPED WORKING AFTER THE SURGERY WAS COMPLETE. THE PATIENT HAD TO GO BACK FOR A SECOND SURGERY IN ORDER TO REPLACE THE DOPPLER. THIS REQUIRED THE PATIENT TO UNDERGO A SECOND GENERAL ANESTHESIA, INCREASED THE RISK OF INFECTION, INCREASED THE RISK OF NEUROVASCULAR ISSUES AND DELAYED DISCHARGE FROM HOSPITAL."

  Patient problems: No Code Available

  MAUDE report 7048212 ↗
• MalfunctionNov 21, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED TO CUSTOMER RELATIONS: ": (B)(6) ¿ THE CRYSTAL PREMATURELY SEPARATED FROM THE COVER AFTER THE SURGERY WAS COMPLETE. THE PATIENT HAD TO RETURN TO THE OPERATING ROOM FOR A SECOND SURGERY TO HAVE A NEW DOPPLER PUT IN."

  Patient problems: No Code Available

  MAUDE report 7048197 ↗
• InjuryNov 3, 2017Detachment Of Device Component; Detachment Of Device Component

  THE CUSTOMER REPORTED THAT, DURING A FREE TISSUE TRANSFER PROCEDURE, THE COOK-SWARTZ DOPPLER PROBE MALFUNCTIONED POSTOPERATIVELY, RESULTING IN A DECREASE IN SIGNAL. THE PATIENT HAD TO BE RETURNED TO THE OPERATING ROOM TO DETERMINE THE CAUSE OF THE DECREASE IN THE VENOUS SIGNAL. IT WAS ULTIMATELY DISCOVERED THAT THE DOPPLER PROBE HAD COME LOOSE FROM THE SILASTIC CUFF. ANOTHER IMPLANTABLE DOPPLER WAS ULTIMATELY PLACED. THE DEVICE WAS RETURNED, AND THE INVESTIGATION OF THE DEVICE WAS COMPLETED.

  Patient problems: No Code Available

  MAUDE report 6998730 ↗
• InjuryOct 27, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  THE CUSTOMER REPORTED THAT, DURING A PHARYNGEAL-MANDIBULAR TUMOR EXCISION WITH AN ANTERIOR LATERAL THIGH OSTEO-CUTANEOUS FREE TISSUE TRANSFER, THE COOK-SWARTZ DOPPLER PROBE SIGNAL BECAME FAINT. THIS REPORTEDLY OCCURRED IN THE INTENSIVE CARE UNIT, 4 HOURS STATUS POST PROCEDURE. THE PATIENT HAD TO RETURN TO THE OPERATING ROOM DUE TO THIS REPORTED DECREASE IN THE DOPPLER SIGNAL, WHICH IS BELIEVED TO BE SECONDARY TO A FAULTY IMPLANTABLE DOPPLER WIRE. THE PATIENT RECEIVED UNINTENDED ANESTHESIA, AND AN OPERATION TO DETERMINE THE CAUSE OF THE DECREASE IN DOPPLER SIGNAL. THE DEVICE IS REPORTEDLY UNAVAILABLE FOR RETURN.

  Patient problems: No Code Available

  MAUDE report 6983447 ↗
• InjuryOct 25, 2017Detachment Of Device Component; Detachment Of Device Component

  THE CUSTOMER REPORTED THAT THE COOK-SWARTZ DOPPLER PROBE DOPPLER WIRES WERE COMING LOOSE POST OPERATIVELY, WHICH NECESSITATED THE REOPENING OF THE PATIENT'S NECK INCISION TO DETERMINE WHAT RESULTED IN THE LOSS OF THE DOPPLER SIGNAL. THE DOPPLER MALFUNCTION REPORTEDLY DIRECTLY CONTRIBUTED TO THE ADDITIONAL MEDICAL INTERVENTION. THE PATIENT'S ORIGINAL PROCEDURE WAS A PHARYNGECTOMY WITH ANTERIOR LATERAL THIGH FREE TISSUE TRANSFER.

  Patient problems: No Code Available

  MAUDE report 6977434 ↗
• InjuryOct 25, 2017Detachment Of Device Component; Detachment Of Device Component

  THE CUSTOMER REPORTED THAT THE COOK-SWARTZ DOPPLER PROBE DOPPLER WIRES WERE COMING LOOSE POST OPERATIVELY, WHICH NECESSITATED THE REOPENING OF THE PATIENT'S NECK INCISION TO DETERMINE WHAT RESULTED IN THE LOSS OF THE DOPPLER SIGNAL. THE DOPPLER MALFUNCTION REPORTEDLY DIRECTLY CONTRIBUTED TO THE ADDITIONAL MEDICAL INTERVENTION. THE PATIENT'S ORIGINAL PROCEDURE WAS A PHARYNGECTOMY WITH ANTERIOR LATERAL THIGH FREE TISSUE TRANSFER.

  Patient problems: No Code Available

  MAUDE report 6977047 ↗
• InjuryOct 12, 2017Detachment Of Device Component; Detachment of Device or Device Component; Detachment Of Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE COOK-SWARTZ DOPPLER PROBE DID NOT ADHERE TO THE SILASTIC CUFF THAT WRAPS AROUND THE VESSEL. THIS ALLEGEDLY RESULTED IN POST OPERATIVE COMPLICATIONS, AND MAY HAVE REPORTEDLY NECESSITATED THE NEED FOR A TRIP BACK TO THE OPERATING ROOM.

  Patient problems: No Code Available

  MAUDE report 6945250 ↗
• MalfunctionApr 18, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ESOPHAGECTOMY PROCEDURE WITH JEJUNAL GRAFT. THE PHYSICIAN ATTACHED A COOK-SWARTZ DOPPLER PROBE BUT IT MALFUNCTIONED. THE PHYSICIAN USED ANOTHER COOK-SWARTZ DOPPLER PROBE, WHICH FUNCTIONED FOR A CERTAIN AMOUNT OF TIME, BUT LATER FAILED. THE PATIENT UNDERWENT TWO ADDITIONAL PROCEDURES IN RELATION TO THIS ISSUE SINCE THE PHYSICIAN WAS NOT ABLE TO DETECT THE BLOOD FLOW VIA THE PROBE. ADDITIONAL INFORMATION WAS REQUESTED REGARDING THE FAILURE OF THE DEVICE AND THE TWO ADDITIONAL PROCEDURES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: No Information

  MAUDE report 6499539 ↗