TRAPLINERRecalls & reported problems across all models

We found 6 models of TRAPLINER by Teleflex Incorporated in the FDA's device registry (GUDID). Together they are named in 49 adverse event reports in the FDA's MAUDE database, received between Sep 5, 2019 and Nov 7, 2025 — classified as 5 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Material Separation” (16 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 TRAPLINER problems

TRAPLINER models

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

• TRAPLINER IPN914357

  Catheter, percutaneous
  16 reports
• TRAPLINER IPN914358

  Catheter, percutaneous
  14 reports
• TRAPLINER IPN914359

  Catheter, percutaneous
  8 reports
• TRAPLINER IPN913563

  Catheter, percutaneous
  4 reports
• TRAPLINER IPN913564

  Catheter, percutaneous
  4 reports
• TRAPLINER IPN913562

  Catheter, percutaneous
  3 reports

Recent TRAPLINER adverse event reports

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

• MalfunctionNov 7, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT: "THE TRAPLINER WAS ADVANCED TOO FAR EXPOSING THE COLLAR OUTSIDE OF THE GUIDE CATHETER. WHEN REALIZED PHYSICIAN ATTEMPTED TO CORRECT AND PULL BACK INTO THE GUIDE CATHETER CAUSING THE TRAPLINER TO BREAK INTO PIECES AT THE FLEX POINT WHILE CROSSING THE VD-OM. CATHETER WAS RETRIEVED SUCCESSFULLY WITH A GUIDELINER AND BALLOON AND PROCEDURE WAS COMPLETED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23494576 ↗
• MalfunctionOct 10, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT "PRODUCT SEPARATED INTO 2 PIECES. IT BROKE ENTERING INTO THE HEMOSTASIS VALVE. NO AIR, PARTICULATE OR COMPONENT WAS REPORTED ENTERING THE VASCULATURE. NO HARM, INJURY OR CONSEQUENCE WAS REPORTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23264420 ↗
• MalfunctionJul 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT: "TRAPLINER WAS INSERTED AS USUAL. UPON FIRST DEVICE EXCHANGE, THE BALLOON WAS UNABLE TO ENTER THE EXTENSION PORTION, AND THE ENTIRE SYSTEM WAS REMOVED. THERE WAS A COLLAR SEPARATION, THE HYPOTUBE DID NOT VISUALLY APPEAR DAMAGED. IT WAS UNCLEAR WHETHER THE COLLAR SEPARATED DURING THE EXCHANGE OR IF IT HAD BEEN DAMAGED BEFORE USE. THERE WAS NO REPORTED PATIENT HARM OR CONSEQUENCE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22518683 ↗
• MalfunctionMay 9, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT: "UPON REMOVAL FROM THE HOOP, THE TRAPLINER WAS FOUND TO BE IN TWO SEPARATE PIECES. ANOTHER TRAPLINER WAS USED SUCCESSFULLY." THE ISSUE WAS IDENTIFIED PRIOR TO USE; THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21992540 ↗
• MalfunctionAug 22, 2024Material Separation; Insufficient Device Problem Information; Material Separation; Insufficient Device Problem Information

  IT WAS REPORTED "TRAPLINER WAS BEING USED DURING A CASE, WHEN INSERTING FURTHER INSTRUMENTS THE TRAPLINER BROKE AT THE ACCESS POINT ABOVE THE HALF PIPE." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". ADDITIONAL QUESTIONS HAVE BEEN REQUESTED FROM THE CUSTOMER, HOWEVER NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20035848 ↗
• MalfunctionJul 15, 2024Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT: " HYPO TUBE PUSH ROD GOT DETACHED FROM HALF PIPE. MEDICAL PROCEDURE WAS BEING PERFORMED WAS " PERCUTANEOUS TRANSFEMORAL CORONARY ANGIOPLASTY" DEVICE REMOVED ENTIRELY AND TREATMENT GOT DELAYED DUE TO THIS DEFECT." ADDITIONAL INFORMATION: THE ISSUE OCCURRED AT THE END OF THE PROCEDURE WHICH WAS VIA THE RCA. THE LESION WAS AT THE PROXIMAL END OF THE RCA & DISTAL RCA. THE PROCEDURE WAS COMPLETED BUT THE DEVICE WAS DAMAGED DURING EXTRACTION. THE DEVICE WAS REMOVED ENTIRELY, AND TREATMENT GOT DELAYED DUE TO THIS DEFECT. THE PATIENT WAS REPORTED AS FINE WIT REPORTED HARM OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19738338 ↗
• MalfunctionApr 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: DURING A PROCEDURE, THE RT PREPPING THE TRAPLINER FLUSHED THE DEVICE. THE RT NOTED THAT THE TIP WAS SEPARATED. THE DEVICE WAS NEVER INSERTED INTO THE PATIENT. IT WAS SET ASIDE AND ANOTHER 8F TRAPLINER WAS PREPPED AND USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19211327 ↗
• MalfunctionMar 27, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: "THE TECH SAID THAT THE HALF PIPE BROKE INTO 2 PIECES SEPARATED INSIDE THE GUIDE CATHETER. THEY HAD TO PULL EVERYTHING OUT , IT WAS TRAPPED WITH A BALLOON AND PULLED OUT ALONG WITH THE GUIDE CATHETER. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION NEEDED DUE TO PRODUCT AND NO REPORTED PATIENT HARM. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18984970 ↗
• MalfunctionMar 27, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT "THE SCRUB TECH, SAID THE DEVICE BROKE INTO 2 PIECES. NO MORE INFORMATION WAS PROVIDED." ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18984943 ↗
• MalfunctionMar 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT: "THE BALLOON SECTION BENT & SEPARATED WHILE LOADING INTO THE GUIDE CATHETER. TRAP LINER BUCKLED & SEPARATION OCCURRED AFTER MINIMAL FORCE WAS APPLIED TO ADVANCE. TRAP LINER WAS REMOVED & A SECOND TRAP LINER WAS INSERTED & USED." ADDITIONAL INFORMATION: THE ISSUE OCCURRED PRIOR TO USE ON THE PATIENT. THE TRAPLINER BROKE MID BALLOON. THE TRAPLINER WAS REMOVED FROM GUIDE CATH --NEW ONE OPENED AND USED WITHOUT ISSUE. THERE WAS NO EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18967966 ↗
• MalfunctionDec 19, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT: SMALL MARKER AT TIP OF CATHETER CAME OFF IN A HEAVILY CALCIFIED RCA. DR WAS ABLE TO INFLATE A BALLOON DISTAL TO IT AND DRAG THE PIECE OUT AND DOWN INTO THE SHEATH. HE HAD TO LOSE ACCESS, CUT THE SHEATH AND REMOVE THE PIECE WITH THE BALLOONED INFLATED ALONG WITH THE REST OF THE TRAPLINER. NO HARM WAS CAUSED TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18354032 ↗
• MalfunctionAug 23, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT: A PIECE OF TRAPLINER BROKE OFF WHEN TECH WAS PREPPING IT. NOT USED ON A PATIENT. NO ADDITIONAL INFORMATION RECIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17601453 ↗
• InjuryFeb 24, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CARDIOLOGIST WAS PERFORMING A COMPLEX CTO TO THE LAD. THE TRAPLINER WAS USED. THERE WAS RETROGRADE AND ANTEGRADE ACCESS VIA RIGHT RADIAL. MICRO-CATHETERS AND GUIDEWIRES WERE USED IN THE VESSEL. AN INTRAVASCULAR ULTRASOUND (IVUS) ATTEMPT WAS UNSUCCESSFUL - UNABLE TO PROGRESS THROUGH CATHETER IS AREA OF SUBCLAVIAN. THE GUIDEWIRES WERE STUCK IN THE CATHETER. WHEN THE TRAPLINER WAS REMOVED, A SPLIT WAS IDENTIFIED ON THE CATHETER. ADDITIONAL INFORMATION ON 23FEB2023: THE ACCOUNT REPORTED THAT THERE WAS MULTIPLE 0.014" GUIDEWIRES IN THE TRAPLINER CATHETER. A 135CM MICROCATHETER WAS ALSO USED DURING THE PROCEDURE. GUIDEWIRE ACCESS WAS EVENTUALLY LOST DURING THE PROCEDURE. THE TRAPLINER WAS REMOVED IN ITS ENTIRETY, AND NO FRAGMENTS WERE LEFT IN THE VESSEL. IT WAS REPORTED THAT THE PERFORATION OCCURRED IN THE DISTAL LAD AND WAS TREATED WITH 2X2MM COILS. THERE WAS NO REPORT OF SIGNIFICANT BLOOD LOSS, AND THE PATIENT DID NOT REQUIRE ANY BLOOD TRANSFUSIONS. IT WAS REPORTED THAT THE PATIENT RECEIVED ADDITIONAL HOSPITALIZATION/MEDICAL CARE DUE TO THIS EVENT. THE CTO WAS ABORTED DUE TO THE PERFORATION. THE PATIENT'S CURRENT CONDITION IS REPORTED AS FINE.

  Patient problems: Perforation of Vessels

  MAUDE report 16440043 ↗
• MalfunctionFeb 2, 2023Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT,"BALLOON RUPTURED AT 12 ATM. 7F GUIDE EXTENSION (TRAPLINER) BROKE OFF WHEN TRYING TO REMOVE FROM GUIDE CATHETER." ADDITIONAL INFORMATION WAS REPORTED ON (B)(6) 2023: PROCEDURE WAS A HIGH-RISK PCI TO THE LAD WITH THE LESION IN THE PROXIMAL LAD. THE VESSEL WAS CALCIFIED AND NOT TORTUOUS. NO BALLOON FRAGMENTS WERE NOTED TO BE SEPARATED AFTER IT BURST. THE TRAPLINER WAS BROKEN BETWEEN THE HALF PIPE AND THE BALLOON. INCIDENT OCCURRED INSIDE THE BODY. PART OF THE TRAPLINER WAS PULLED OUT COMPLETELY WITH GUIDE CATHETER. THE PHYSICIAN HAD TO DISSECT THE GUIDING CATHETER TO FIND THE BROKEN GUIDE EXTENSION BEFORE PROCEEDING WITH INTERVENTION. NO PATIENT HARM NOTED. EVERYTHING WAS COMPLETELY REMOVED. THE PHYSICIAN USED AN OTW BALLOON FOR TRAPPING TECHNIQUE AND AN ATHERECTOMY DEVICE TO COMPLETE THE PROCEDURE. PATIENT'S CURRENT CONDITION WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16283173 ↗
• MalfunctionOct 14, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT: CUSTOMER STATED THAT THE UNIT WAS NOTICED TO BE DEFECTIVE BEFORE IT WAS TO BE LOADED INTO THE HEMOSTASIS VALVE. ADDITIONAL INFORMATION: DURING A CORONARY INTERVENTION, THE DEVICE DID NOT PAST THE HEMOSTASIS VALVE AND NEVER ENTERED THE PATIENT. THE DEVICE BROKE IN 2 PIECES DURING A CORONARY INTERVENTION. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15603716 ↗

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