Stingray™ LP H749393120SR0Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08714729903352), received between Dec 17, 2018 and Mar 26, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2025Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT A BALLOON ISSUE OCCURRED. A STINGRAY LP WAS SELECTED FOR USE. DURING THE PREPARATION, IT WAS NOTED THAT THERE WAS A CONTRAST COMING OUT OF THE BALLOON AS IF IT HAD BURST. THERE WAS NO ISSUE WITH THE PATIENT OR PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21697720 ↗
• MalfunctionFeb 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED CORONARY ARTERY. A STINGRAY LP BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STINGRAY BALLOON RUPTURED AT 6 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE METHOD. THERE WAS NO PATIENT COMPLICATIONS REPORTED POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21300149 ↗
• MalfunctionMay 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A STINGRAY LP CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON LOST PRESSURE AND BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19243637 ↗
• MalfunctionDec 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A STINGRAY LP CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WAS RUPTURED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18406454 ↗
• MalfunctionJul 18, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE DEVICE WAS STUCK ON THE WIRE. THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY. A STINGRAY CATHETER RE-ENTRY DEVICE AND HORNET GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE WAS ADVANCE OVER A NON-BSC GUIDEWIRE THAT WAS IN THE SUBINTIMAL SPACE. WHEN THE NON-BSC GUIDEWIRE WAS REMOVED AND INSERTED A HORNET 14 FOR RE-ENTRY. HOWEVER, THE DEVICE WAS STUCK ON THE WIRE. THE DEVICE WAS REMOVED TOGETHER WITH THE HORNET DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15041671 ↗
• MalfunctionSep 9, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BALLOON HAD A HOLE. A STINGRAY LP RE-ENTRY DEVICE WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE BALLOON HAD A HOLE. THE DEVICE NEVER ENTERED THE PATIENT'S BODY. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12451590 ↗
• MalfunctionMay 4, 2021Contamination; Tear, Rip or Hole in Device Packaging; Contamination; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE STERILITY OF THE CATHETER WAS COMPROMISED. A STINGRAY LP CATHETER WAS SELECTED FOR USE. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE ENTIRE OUTSIDE AND INNER PACKAGE HAD A HOLE AND THE PRODUCT STERILITY LOOKED COMPROMISED. THE DEVICE NEVER ENTERED THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11772734 ↗
• MalfunctionApr 14, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PROCEDURE WAS NOT RESOLVED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A STINGRAY LP WAS SELECTED FOR USE. THE BALLOON WAS PREPPED CORRECTLY OUTSIDE THE BODY. DURING PROCEDURE, THE BALLOON WAS INSERTED AND INFLATED AS NORMAL; STICK WAS PERFORMED WITH A WIRE WITH NO PROBLEM. SUBSEQUENTLY, THE WIRE WAS TRIED TO SWAP WITH A PILOT 200 BUT IT COULD NOT EXIT THROUGH THE STINGRAY BALLOON CATHETER. THE PILOT 200 WAS THEN REMOVED AND REINSERTED BUT FAILED. PER PHYSICIAN, IT WAS DIFFICULT TO PUSH THE PILOT THROUGH THE STINGRAY HUB. A FRESH PILOT 200 WAS USED AND EXPERIENCED THE SAME RESISTANCE AT THE HUB. THE PROCEDURE COULD NOT BE COMPLETED AS PLANNED WITH THE STINGRAY STICK AND SWAP TECHNIQUE DUE TO WIRE RESISTANCE AT HUB AND TIME OR CONTRAST EXPOSURE. NO COMPLICATIONS WERE REPORTED AND PATIENT WILL RETURN FOR FURTHER TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11668605 ↗
• MalfunctionSep 29, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT MARKER DOTS WERE MISSING. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE DEVICE WAS PREPPED CORRECTLY. DURING PROCEDURE, THE DEVICE WAS INSERTED INTO THE PATIENT'S BODY, HOWEVER THE MARKER DOTS COULD NOT BE SEEN ON ANGIOGRAPHY. THE DEVICE WAS PULLED BACK NORMALLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT A SECOND STINGRAY WAS PULLED AND PERFORMED AS EXPECTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS FINE POST PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10600922 ↗
• MalfunctionAug 24, 2020Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE PACKAGE SEAL WAS COMPROMISED. A STINGRAY LP CATHETER RE-ENTRY DEVICE WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE PACKAGE SEAL OF THE DEVICE WAS NOT FULLY SEALED. PRODUCT STERILITY WAS QUESTIONED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10443343 ↗
• MalfunctionMay 26, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A STINGRAY LP CATHETER WAS SELECTED FOR USE IN THE MID-DISTAL RIGHT CORONARY ARTERY. DURING PROCEDURE, AFTER THE STINGRAY BALLOON WAS PLACED IN THE TARGET LESION, THE NON BSC WIRE THAT WAS USED TO PLACE DOWN THE BALLOON WAS REMOVED IN ORDER TO PLACE THE STINGRAY GUIDEWIRE DOWN. HOWEVER, IT WAS NOTED THAT THE PHYSICIAN WAS UNABLE TO GET THE THE WIRE TO PASS THROUGH THE DISTAL 1/3 OF THE BALLOON CATHETER. THE STINGRAY WIRE WAS REMOVED AND ANOTHER NON BSC WIRE WAS PLACED DOWN THE BALLOON LUMEN BUT WOULD ALSO NOT PASS THROUGH THE DISTAL 1/3. THE BALLOON CATHETER WAS REMOVED AND THE PHYSICIAN DECIDED TO STOP AND BRING THE PATIENT BACK FOR ANOTHER ATTEMPT IN OPENING THE CTO AT A LATER DATE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS WELL AND UNHARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10089266 ↗
• MalfunctionMar 5, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON BURST OCCURRED. A STINGRAY LP RE-ENTRY DEVICE WAS SELECTED FOR IN A CHRONIC TOTAL OCCLUSION PROCEDURE. PRIOR TO PREPARATION, IT WAS NOTED THAT THE BALLOON IN THE DEVICE ALREADY BURST. A NEW STINGRAY WAS OPENED AND THEY CARRIED ON WITH THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9793232 ↗
• MalfunctionJul 5, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A STINGRAY GUIDEWIRE BECAME STUCK IN THE STINGRAY LP. THE TARGET LESION WAS LOCATED IN THE TOTALLY OCCLUDED RIGHT CORONARY ARTERY. A STINGRAY GUIDEWIRE AND STINGRAY LP CATHETER WERE SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE WOULD NO LONGER EXIT THE CATHETER AND BECAME CAUGHT AND LODGED IN THE EXIT PORT AFTER MULTIPLE ATTEMPTS TO EXIT THE BALLOON AND ENTER THE TRUE LINE AFTER A PLANNED DISSECTION. BOTH DEVICES WERE REMOVED TOGETHER FROM THE PATIENT'S BODY THROUGH THE GUIDE CATHETER. THE PROCEDURE WAS NOT COMPLETED DUE TO THE EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8764508 ↗
• MalfunctionDec 17, 2018Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE WIRE FROZE INSIDE THE STINGRAY BALLOON. THE CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN RIGHT CORONARY ARTERY. A 185CM STINGRAY GUIDEWIRE AND A STINGRAY LP CATHETER WERE SELECTED FOR USE. DURING THE PROCEDURE, THE STINGRAY BALLOON WAS DISTALLY DOWN WITH THE WIRE TO DO RE-ENTRY; HOWEVER, THE WIRE FROZE INSIDE THE STINGRAY BALLOON. THE DEVICES WERE THEN TAKEN OUT FROM THE VESSEL AND THE VESSEL WAS SUCCESSFULLY OPENED WITH THE USE OF STENTS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE DEVICES WERE REMOVED SAFELY FORM THE PATIENT'S BODY. THE PROCEDURE WAS SUCCESSFUL WITH DIFFERENT TECHNOLOGY. NO PHYSICAL DAMAGE WERE OBSERVED ON THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8169228 ↗