RescueNet™ DGN-538Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10840253107425), received between Nov 26, 2018 and Feb 4, 2026 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2026Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESCUENET DISPOSABLE RETRIEVAL DEVICE WAS INSPECTED ON JANUARY 15, 2026. DURING UNPACKING OF THE DEVICE, IT WAS OBSERVED THAT THE SEAL WAS PEELED OFF. THERE WERE NO PATIENT INVOLVEMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260347 ↗
• MalfunctionApr 23, 2025Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESCUENET DEVICE WAS USED IN THE STOMACH DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DEVICE WAS SENT THROUGH THE SCOPE, AND A BLUE PIECE FROM THE RESCUE NET WAS PUSHED OUT OF THE SCOPE. THIS PIECE WAS THEN RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESCUENET DEVICE. THERE WERE NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21894711 ↗
• InjuryJan 30, 2023Use of Device Problem; Material Split, Cut or Torn; Use of Device Problem; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESCUENET RETRIEVAL NET WAS TO BE USED TO PLACE AN ENDOSCOPY PILL CAMERA DURING AN ESOPHAGOGASTRODUODENOSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO PLACE A 26MM ENDOSCOPY PILL CAMERA USING THE RESCUENET. THE PILL CAMERA WAS PLACED IN THE RESCUENET AND THE NET WAS CLOSED. WHILE PASSING THE SCOPE AND DEVICE WITH THE ENCLOSED PILL CAMERA THROUGH THE BITE BLOCK, THE NET TORE AND THE PILL CAM WAS LOST IN THE THROAT OF THE PATIENT. THERE WAS DIFFICULTY RETRIEVING THE PILL CAM AND THE PATIENT BECAME AT RISK. THE PROCEDURE WAS CANCELLED, AND THE PATIENT WENT TO SURGERY TO HAVE THE PILL CAM REMOVED. THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND THE STANDARD OF CARE AND HAS BEEN DISCHARGED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. NOTE: THE RESCUENET WAS BEING USED TO PLACE AN ENDOSCOPY PILL CAMERA; HOWEVER, THE RESCUENET RETRIEVAL NET IS INDICATED FOR USE IN ENDOSCOPIC RETRIEVAL OF FOREIGN OBJECTS, FOOD BOLUS, TISSUE FRAGMENTS AND EXCISED TISSUE SUCH AS POLYPS. THE DEVICE IS NOT INDICATED TO PLACE ENDOSCOPY PILL CAMERAS.

  Patient problems: Insufficient Information

  MAUDE report 16268092 ↗
• MalfunctionMar 30, 2022Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESCUENET RETRIEVAL NET WAS USED DURING A PERORAL ENDOSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE CAPSULE ENDOSCOPE WAS GRASPED OUTSIDE THE BODY AND TRIED TO BE INSERTED INTO THE DUODENUM WITH THIS DEVICE, THE NET IN THE STOMACH WAS DETACHED AND THE PRESSURE BOND PART CAME OFF AND COULD NOT BE INSERTED INTO THE DUODENUM. FOUR RESCUENETS WERE USED TO REMOVE THE RESIDUE IN THE STOMACH. WHEN THE RESCUENET LOOP WAS REMOVED FROM THE BODY THE NET WAS NOTICED TO BE TORN. THE PROCEDURE WAS COMPLETED WITH A NON BSC DEVICE. THE PROCEDURE TOOK 5 HOURS TO COMPLETE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13956396 ↗
• InjurySep 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESCUENET RETRIEVAL NET WAS USED FOR FOOD IMPACTION IN THE ESOPHAGUS/STOMACH DURING AN ENDOSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE NET WAS TORN AND GOT FULLY DETACHED FROM THE LOOP AFTER CAPTURING THE FOREIGN OBJECT. NO ISSUES WERE PRESENT UPON OPENING THE PACKAGE. REPORTEDLY, THE DETACHED PIECE WAS RETRIEVED BUT IT WAS UNKNOWN HOW IT WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT RESCUENET. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE/FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12464006 ↗
• InjuryJul 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESCUENET RETRIEVAL NET WAS USED DURING A GASTROSCOPY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, WHILE ATTEMPTING TO RETRIEVE AN OBJECT FROM A CHILD'S STOMACH, THEY WERE TO CAPTURE THE OBJECT IN THE RESCUE NET AND HAD PULLED OUT TO ABOUT THE THROAT AREA WHEN THE NETTING SEPARATED FROM THE SNARE PORTION, DROPPING THE OBJECT NEAR THE AIRWAY. THE OBJECT WAS ABLE TO BE GRABBED WITH INSTRUMENTS BEFORE IT COULD GO DOWN ANY FURTHER. IT IS UNKNOWN HOW THE DETACHED NET WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12174340 ↗
• InjuryNov 3, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESCUANT RETRIEVAL NET WAS USED IN THE STOMACH DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, THE SNARE LOOP AND NET FULL OF FOOD WAS DETACHED. REPORTEDLY, THE DEVICE FUNCTIONED SMOOTHLY AND THERE WAS NO DIFFICULTY CAPTURING THE OBJECT. ADDITIONALLY, NO VISIBLE ISSUE WAS NOTED WITH THE HANDLE AND THE DEVICE WAS NOT EXCESSIVELY MANIPULATED. THE PATIENT DID NOT HAVE ANY PHYSIOLOGICAL ISSUES THAT MIGHT HAVE CONTRIBUTED TO THE EVENT. THE DETACHED SNARE LOOP AND NET WAS RETRIEVED USING A RAT TOOTH FORCEPS. THE PROCEDURE WAS THEN COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10777644 ↗
• MalfunctionOct 5, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESCUENET RETRIEVAL NET WAS USED IN THE STOMACH AND ESOPHAGUS TO REMOVE A FOOD BOLUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS REPORTED THAT THE NET WAS FULLY DETACHED FROM THE OUTER RING AND THE NET WAS NOT RETRIEVED FROM INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10627149 ↗
• MalfunctionFeb 18, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESCUANT RETRIEVAL NET WAS PREPARED FOR USE DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION AND OUTSIDE THE PATIENT, A HAIR-LIKE FOREIGN OBJECT WAS FOUND INSIDE THE STERILE POUCH OF THE DEVICE BEFORE IT WAS UNPACKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESCUANT RETRIEVAL NET. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9721091 ↗
• MalfunctionOct 7, 2019Structural Problem; Defective Device

  DEVICE IS NOT STIFF ENOUGH TO USE IN A SAFE APPROPRIATE MANNER CAUSING THE SCOPE TO BE ENTERED IN TO THE PATIENT'S MOUTH 3-4 TIMES INCREASING THE RISK OF ASPIRATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9161719 ↗
• MalfunctionJan 2, 2019Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESCUENET RETRIEVAL NET WAS USED IN THE SMALL INTESTINE DURING A REMOVAL OF CAPSULE PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE NET WAS TORN WHILE REMOVING THE CAPSULE CAMERA WHICH WAS ABOUT 1.5CM LONG. REPORTEDLY, THERE WAS NO DIFFICULTY ENCOUNTERED IN CAPTURING THE CAPSULE AND THE RESCUENET WAS NOT EXCESSIVELY MANIPULATED TO RETRIEVE IT. JUST WHEN THE RESCUENET WAS CLOSED TIGHT, THE NET WAS TORN. IN ADDITION, THE PATIENT DID NOT HAVE ANY PHYSIOLOGICAL ISSUES. ANOTHER RESCUENET RETRIEVAL NET WAS USED AND THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED USING A THIRD RESCUENET RETRIEVAL NET. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE DEVICE RETURNED WITHOUT THE NET, HOWEVER, IT WAS INSPECTED UNDER MAGNIFICATION AND RESIDUES OF THE NET ARE STILL ATTACHED TO THE LOOP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8209564 ↗
• InjuryNov 26, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESCUENET RETRIEVAL NET WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN REMOVING THE BOLUS, IT WAS NOTED THAT THE NET WAS TORN. REPORTEDLY, WHEN THEY ASSESSED FOR THE MISSING NET, IT WAS NOTED THAT THE NET WAS EMBEDDED ON THE PATIENT'S ESOPHAGUS. THEY USED ANOTHER RETRIEVAL DEVICE TO RETRIEVE THE NET. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8102478 ↗