TURNPIKE IPN913580Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10841156100728), received between May 22, 2019 and Mar 18, 2020 — classified as 5 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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.

• InjuryMar 18, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP BROKE OFF IN THE CORONARY ARTERY THEY WERE WORKING ON. THE PROCEDURE WAS COMPLETED NORMALLY BY PLACING STENTS. THE TIP WAS NOT REMOVED FROM THE BODY. IT WAS STENTED OVER. THERE WAS NO SPECIAL PROCEDURE REQUIRED FROM LOSING THE TIP. THERE WAS NOT VESSEL DAMAGE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 9848116 ↗
• InjuryJan 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED: THE CUSTOMER HAD SMOOTH 135CM TURNPIKE OVER A WIRE AND ENGAGED IN CALCIUM, TORQUEING THE DEVICE, AND PART OF THE TIP BROKE OFF ON THE WIRE. BROKEN TIP WAS ABLE TO BE RETRIEVED AS THE UNIT WAS ON A WIRE. THE CASE WAS COMPLETED SUCCESSFULLY AS THE BROKEN UNIT WAS FULLY RETRIEVED, AND CUSTOMER USED A TURNPIKE GOLD TO FINISH CASE.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 9596410 ↗
• InjuryJan 15, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE TURNPIKE WAS USED TOR A COMPLEX PCI INVOLVING THE CIRC AND LAD. A WIRE WAS ADVANCE ACROSS A STENT STRUT AND FOLLOWED BY THE TURNPIKE CATHETER. UPON REMOVAL OF THE TURNPIKE, IT GOT STUCK ON THE STENT AND WHEN IT WAS PULLED BACK WITH RESISTANCE A SMALL PIECE OF THE TURNPIKE TIP BROKE OFF AND REMAINED IN THE VESSEL. THE PHYSICIAN FELT RESISTANCE AT STENT STRUT, HE TRIED TO SPIN, THOUGH WOULD NOT CROSS. TIP BROKE ON PULLBACK. THE PHYSICIAN STATED, THAT HE THINKS THE WIRE WAS BEHIND THE STENT AND THE TURNPIKE GOT STUCK BECAUSE OF THAT. THE PIECE OF THE TURNPIKE WAS JAILED BETWEEN THE LUMEN AND STENT. THE PATIENT TOLERATED THE PROCEDURE WELL AND IS DOING GREAT. NO PATIENT HARM DONE. THERE IS NO PLAN TO REMOVE THE "PIECE" OF THE TURNPIKE.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 9590748 ↗
• InjuryOct 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DISTAL PART OF THE TIP OF THE CATHETER "BROKE OFF" WHILE THE CARDIOLOGIST WAS IN THE MIDDLE OF PCI OF THE CIRCUMFLEX ARTERY. THE VESSEL SIZE WAS 3.5MM OF THE CIRCUMFLEX ARTERY AND THE ARTERY WAS MODERATELY TORTUOUS. THE PATIENT WAS HIGHLY CALCIFIED AND 99% OCCLUDED. PHYSICIAN INDICATES HE TORQUED BOTH COUNTER CLOCKWISE AND CLOCKWISE ABOUT 10X CONSECUTIVELY EACH DIRECTION AT A TIME. THE PHYSICIAN WAS NOT ABLE TO RETRIEVE THE TIP AT THAT TIME, SO PHYSICIAN CHOSE TO PLACE A STENT IN THE LESION, AND THE TIP WAS PINNED AGAINST THE WALL OF THE VESSEL BY THAT STENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9167890 ↗
• InjuryMay 22, 2019Separation Problem; Separation Problem

  TIP OF TURNPIKE BROKE OFF. ADDITIONAL INFORMATION RECEIVED 26APR19: THE TIP BROKE; HOWEVER, WAS STILL ATTACHED. THE TIP WAS RETRIEVED, AND CASE COMPLETED. THE VESSEL WAS EVENTUALLY BALLOONED, AND ANOTHER TURNPIKE WAS USED TO DELIVER A DES. NO PATIENT INJURY OR IMPACT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8633285 ↗