SpyGlass DSRecalls & reported problems across all models

We found 2 models of SpyGlass DS by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 173 adverse event reports in the FDA's MAUDE database, received between Jan 15, 2020 and Sep 10, 2026 — classified as 173 malfunctions.

The most frequently reported specific device problem is “Optical Problem” (89 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

Most reported SpyGlass DS problems

SpyGlass DS models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SpyGlass DS M00546650

  Led light source
  154 reports
• SpyGlass DS M0054665R0

  Choledochoscope and accessories, flexible/rigid
  19 reports

Recent SpyGlass DS adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Optical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716134 ↗
• MalfunctionAug 14, 2026Optical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50252027 ↗
• MalfunctionAug 13, 2026Unexpected Shutdown

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50240133 ↗
• MalfunctionJun 8, 2026Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DEVICE WAS INTENDED FOR USE WITH A SPY CONTROLLER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN INITIALLY HAD NORMAL VISUALIZATION. HOWEVER, AFTER SOME TIME, THE IMAGE WAS SUDDENLY LOST COMPLETELY. MULTIPLE ATTEMPTS WERE MADE TO RESTORE THE IMAGE BY DISCONNECTING AND RECONNECTING THE SYSTEM COMPONENTS; HOWEVER, THE ISSUE PERSISTED AND VISUALIZATION WAS NOT RECOVERED. THE PROCEDURE WAS UNABLE TO BE COMPLETED AS A RESULT OF THIS EVENT, AND THE PATIENT WILL BE RESCHEDULED FOR A REPEAT PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25429704 ↗
• MalfunctionMar 23, 2026Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS DIGITAL CONTROLLER WAS USED WITH A SPYSCOPE DS II DURING A CHOLANGIOSCOPY FOR INTERDUCTAL CLEARANCE ON (B)(6) 2026, FOR THE TREATMENT OF CHOLEDOCHOLITHIASIS. DURING THE PROCEDURE, VISUALIZATION WAS LOST. ALTHOUGH SUFFICIENT STONE CLEARANCE WAS ACHIEVED, THE PROCEDURE WAS NOT ABLE TO BE COMPLETED AS A RESULT OF THIS EVENT AND THE PATIENT WAS RESCHEDULED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24662991 ↗
• MalfunctionMar 20, 2026Poor Quality Image

  NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES WERE USED IN THIS EVENT, THREE SPYSCOPE DS II AND ONE SPYGLASS DS CONTROLLER. THIS RECORD REPRESENTS SPY DS CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS CONTROLLER AND THREE SPYSCOPE DS II WERE ATTEMPTED FOR USE IN THE BILE DUCT DURING A CHOLANGIOSCOPE PROCEDURE ON (B)(6) 2026, FOR THE TREATMENT OF STONES. DURING THE PROCEDURE, NO IMAGING WAS OBTAINED, AND THREE DIFFERENT CATHETERS WERE ATTEMPTED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24649147 ↗
• MalfunctionMar 13, 2026Fitting Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A SPYGLASS DS CONTROLLER AND TWO SPYSCOPE DS II WERE ATTEMPTED FOR USE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND CHOLANGIOSCOPY PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, THE SURGICAL TEAM ATTEMPTED TO CONNECT THE SPYSCOPE TO THE CONSOLE AND IT WAS NOT RECOGNIZED. IT WAS INDICATED THAT THERE WAS DIFFICULTY PLUGGING IN THE SCOPE. TROUBLESHOOTING TASKS INCLUDED SWITCHING OFF THE ENTIRE SYSTEM AND UNPLUGGING THE SCOPE BEFORE RETRYING. THE PROBLEM DID NOT RESOLVE. ANOTHER SPYSCOPE WAS ATTEMPTED FOR USE HOWEVER, THE RESULT WAS THE SAME. THE PROCEDURE WAS UNABLE TO BE COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. BOTH SCOPES WERE TESTED WITH A SECOND CONTROLLER FOLLOWING THE PROCEDURE, BOTH SCOPES FUNCTIONED AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24597380 ↗
• MalfunctionFeb 4, 2026Poor Quality Image; Fitting Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS CONTROLLER WAS ATTEMPTED FOR USE DURING A DIAGNOSTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2026, FOR THE TREATMENT OF BILIARY STRICTURE. DURING THE PROCEDURE, THE SPYSCOPE DS CONTROLLER DID NOT DISPLAY AN IMAGE ON THE MONITOR. AFTER INSPECTION, IT APPEARED THAT THERE WAS NOT A PROPER CONNECTION AT THE PORT WHERE THE CATHETER IS CONNECTED TO THE CONTROLLER. THE PHYSICIAN WAS UNABLE TO COMPLETE THE ERCP DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259765 ↗
• MalfunctionFeb 3, 2026Poor Quality Image

  NOTE: THIS REPORT PERTAINS TO THE SPY DS CONTROLLER USED TOGETHER WITH THE TWO SPYSCOPE DS II DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPY DS CONTROLLER AND THE TWO SPYSCOPE DS II WERE USED DURING A CHOLANGIOSCOPY PROCEDURE PERFORMED FOR THE TREATMENT OF STRICTURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SPYSCOPE DS II DID NOT DISPLAY AN IMAGE. A SECOND SPYSCOPE DS II WAS THEN USED, BUT THE IMAGE STILL FAILED TO APPEAR. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. *ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2026* THE CHOLANGIOSCOPY PROCEDURE TOOK PLACE ON (B)(6) 2026. BOTH SCOPES WERE TESTED WITH ANOTHER SPY DS CONTROLLER AND FUNCTIONED AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24247296 ↗
• MalfunctionNov 24, 2025Connection Problem; Connection Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF 2 DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2025-06263 FOR THE FIRST DEVICE, SPY DS CONTROLLER, AND 3005099803-2025-06270 FOR THE FOR THE SECOND DEVICE, SPYSCOPE DS II. IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A SPYSCOPE DS CONTROLLER WAS USED WITH A SPYSCOPE DS II IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2025. DURING THE PROCEDURE, BEFORE THE SCOPE WAS INSERTED IN THE PATIENT, THE SPY DS CONTROLLER WAS REPORTED TO NOT BE WORKING PROPERLY. THE CONTROLLER POWERED UP, BUT THE LAMP WOULD NOT TURN ON. THE SPYSCOPE DS II COULD NOT BE USED DUE TO LACK OF VISUALIZATION. FURTHER TROUBLESHOOTING DETERMINED THAT THERE WAS A FAULTY VIDEO CABLE. THE PROCEDURE WAS UNABLE TO BE COMPLETED AS A RESULT OF THIS EVENT. DOUBLE PIGTAIL STENTS WERE PLACED UNTIL PATIENT CAN BE RESCHEDULED FOR AN ERCP. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23638255 ↗
• MalfunctionOct 28, 2025Optical Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2025-05538 FOR THE SPYSCOPE DS II AND REPORT NUMBER 3005099803-2025-05539 FOR THE SPY DS CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II ACCESS AND DELIVERY CATHETER AND A SPY DS CONTROLLER WERE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED FOR THE TREATMENT OF STONES ON (B)(6) 2025. THE IMAGE OF THE SPYSCOPE DS II WAS LOST APPROXIMATELY FIVE MINUTES INTO THE PROCEDURE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT AND WILL BE RESCHEDULED ON (B)(6) 2025. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE DEVICE WAS NOT RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23405549 ↗
• MalfunctionOct 15, 2025Poor Quality Image; Optical Problem; Poor Quality Image; Optical Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2025-05358 FOR THE SPYSCOPE DS II AND REPORT NUMBER 3005099803-2025-05359 FOR THE SPY DS CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II ACCESS & DELIVERY CATHETER AND A SPY DS CONTROLLER WERE USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED FOR THE TREATMENT OF STONES ON (B)(6) 2025. DURING THE PROCEDURE, THE VISUALIZATION OF THE SPYSCOPE DS II WAS COMPROMISED DUE TO SCREEN LAG. THE MONITOR INTERMITTENTLY SWITCHED BETWEEN A LOADING SCREEN AND THE SPYGLASS LOGO, RESULTING IN LOSS OF IMAGE. THE PROCEDURE WAS NOT COMPLETED SUE TO THIS EVENT AND WILL BE RESCHEDULED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23292511 ↗
• MalfunctionJul 21, 2025Failure to Power Up; Failure to Power Up

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPY DS CONTROLLER WAS ATTEMPTED FOR USE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOPOGRAPHY (ERCP) AND SPYGLASS PROCEDURE FOR THE TREATMENT OF BILIARY OBSTRUCTION ON (B)(6) 2025. IT WAS REPORTED THAT THE CONTROLLER WOULD NOT POWER ON. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22553956 ↗
• MalfunctionJul 3, 2025Poor Quality Image; Connection Problem; Poor Quality Image; Connection Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2025-03117 FOR THE SPYSCOPE DS II AND REPORT NUMBER 3005099803-2025-03118 FOR THE SPY DS CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II ACCESS & DELIVERY CATHETER AND A SPY DS CONTROLLER WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED FOR THE TREATMENT OF MIGRATED STENT IN THE BILE DUCT ON (B)(6) 2025. DURING THE PROCEDURE, THE SPYSCOPE DS II HAD A BLACK AND WHITE IMAGE. THE SPYSCOPE DS II WAS UNPLUGGED AND RE-PLUGGED BACK INTO THE SPY DS CONTROLLER, RESTARTED THE CONTROLLER AND RE-PLUGGING THE VIDEO CABLES; HOWEVER, THE SAME PROBLEM OCCURRED. REPORTEDLY, THEY SWITCHED TO A NEW S-VIDEO CABLE AND CONFIRMED THAT THE VIDEO CABLE SUPPLIED BY BOSTON SCIENTIFIC WAS THE PROBLEM. THE PROCEDURE WAS ABORTED DUE TO THIS EVENT AND WILL BE RESCHEDULED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395419 ↗
• MalfunctionJun 17, 2025Poor Quality Image; Poor Quality Image

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER: 3005099803-2025-02681 FOR THE SPYSCOPE DS II ACCESS & DELIVERY CATHETER AND 3005099803-2025-02683 FOR THE SPY DS CONTROLLER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II ACCESS AND DELIVERY CATHETER AND A SPY DS CONTROLLER WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2025. DURING THE ERCP WITH POC AND EHL, THE SPYGLASS DS DIRECT VISUALIZATION SYSTEM MALFUNCTIONED. ATTEMPTS TO CONNECT THE SPYSCOPE TO THE SYSTEM WERE UNSUCCESSFUL, AS THE LIGHT SOURCE FAILED TO ACTIVATE. DESPITE CHECKING CONNECTIONS AND REBOOTING THE SYSTEM, THE ISSUE PERSISTED, PREVENTING THE PROCEDURE FROM PROCEEDING. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22229397 ↗

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