Stretch™ VL M0061851550Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729160786), received between Jul 31, 2020 and Jun 24, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Calcified” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2024Break; Break

  IT WAS REPORTED THAT, DURING A LITHOTRIPSY PROCEDURE USING A STRETCH VL URETERAL STENT, IT WAS NOTICED DURING UNPACKING THAT THE STENT WAS BROKEN INTO TWO PIECES ALONG THE SHAFT. ANOTHER OF THE SAME STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19602081 ↗
• MalfunctionDec 8, 2022Calcified; Difficult to Remove; Calcified; Difficult to Remove

  IT WAS REPORTED THAT A STRETCH VL URETERAL STENT WAS SUCCESSFULLY REMOVED DURING A URETERAL STENT REMOVAL PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2022. ON (B)(6) 2022, IT WAS NOTED THAT A STENT WAS PLACED IN THE RIGHT URETER TO SUPPORT THE URETER AND HELP REMOVE THE STONES. THE PHYSICIAN ADVISED THE PATIENT TO COME BACK TO THE HOSPITAL FOR RE-EXAMINATION AND EXTUBATION IN JANUARY. ON (B)(6) 2022, THE PATIENT HAD A RE-EXAMINATION AND THE PHYSICIAN FOUND THAT THE STENT WAS CALCIFIED WHICH MADE IT DIFFICULT TO REMOVE. SO, ON (B)(6) 2022, AT AROUND 12:30, STENT REMOVAL WAS PERFORMED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER STRETCH VL URETERAL STENT. IT WAS NOTED THAT THE PATIENT WAS SCHEDULED FOR CHECK-UP'S, TWO MONTHS AFTER THE IMPLANTATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15941256 ↗
• MalfunctionJul 2, 2021Calcified; Difficult to Remove; Calcified; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STRETCH VL URETERAL STENT WAS USED DURING A PROCEDURE IN THE URETER, PERFORMED ON (B)(6) 2021. DURING A PLANNED STENT REMOVAL PROCEDURE ON (B)(6) 2021, IT WAS NOTICED THAT STONES WERE ON THE SURFACE OF THE URETERAL STENT, RESULTING IN DIFFICULTY REMOVING OF THE STENT. THE STRETCH VL URETERAL STENT WAS REMOVED UNDER VISUAL VIEW OF URETEROSCOPY AND HOLMIUM LASER LITHOTRIPSY. IT WAS UNKNOWN IF A NEW STENT WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12108115 ↗
• MalfunctionDec 29, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STRETCH VL URETERAL STENT WAS OPENED ON (B)(6) 2020. PROCEDURAL INFORMATION WAS NOT REPORTED. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, THE PHYSICIAN NOTICED THAT THE STENT WAS BROKEN IN TWO PIECES. ANOTHER STRETCH VL URETERAL STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11089113 ↗
• InjuryJul 31, 2020Calcified; Difficult to Remove; Calcified; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STRETCH VL URETERAL STENT WAS USED DURING A LEFT URETEROSCOPIC HOLMIUM LASER LITHOTRIPSY AND LEFT URETERAL STENT IMPLANTATION PROCEDURE IN THE LEFT URETER. THE EXACT PROCEDURE DATE WAS NOT REPORTED. ON (B)(6) 2020, ONE MONTH AFTER THE STENT PLACEMENT, A STENT REMOVAL PROCEDURE WAS PERFORMED. ACCORDING TO THE COMPLAINANT, DURING THE REMOVAL PROCEDURE AND INSIDE THE PATIENT, WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT, THE STENT WAS DIFFICULT TO REMOVE. THE PATIENT WAS HOSPITALIZED BECAUSE THE STENT COULD NOT BE RETRIEVED. THE PHYSICIAN PERFORMED LEFT URETEROSCOPY EXAMINATION UNDER COMBINED SPINAL EPIDURAL ANESTHESIA IN EMERGENCY. IT WAS FOUND THAT THE PELVIS END OF THE STENT WAS HARDENED AND HAD SECONDARY STONE. THE PHYSICIAN USED A PAIR OF FOREIGN BODY FORCEPS TO RETRIEVE THE STENT. THE STONE ON THE PELVIS END OF THE STENT FELL OFF AND THE PHYSICIAN WAS ABLE TO STRAIGHTEN AND COMPLETELY REMOVE THE STRETCH VL URETERAL STENT. REPORTEDLY THERE WAS NO NEW STENT IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE

  Patient problems: No Code Available

  MAUDE report 10349858 ↗