ARROW IPN035902Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801902013156), received between Feb 12, 2019 and Nov 4, 2021 — classified as 7 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

1 FDA recall record name this device's identifier.

12 other recalls cover devices cleared under the same FDA submission (K011056); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jan 11, 2022Terminated

   The firm received reports indicating PTD tip separation during use.

   Z-0629-2022 · Root cause: Process change control · FDA record ↗

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.

• InjuryNov 4, 2021Break; Break

  COMPLAINT FOUND IN MAUDE DATABASE REPORTS: "DURING LEFT UPPER ARM FISTULA PROCEDURE, TIP BROKE OFF TEROTOLA THROMBECTOMY DEVICE. IT WAS UNABLE TO BE RETRIEVED AND WAS LEFT IN THE PATIENT."

  Patient problems: Foreign Body In Patient

  MAUDE report 12751414 ↗
• MalfunctionJun 10, 2021Separation Problem; Separation Problem

  DURING A THROMBECTOMY OF A PATIENT'S LOOP GRAFT, THE USER HAD DONE A FEW PASSES AND NOTICED THE BASKET WAS NOT FULLY OPENING UP. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, THE CATHETER HAD COME DETACHED AND STARTED TO SLIDE UP OVER THE BASKET, NOT ALLOWING THE BASKET TO FULLY OPEN. THE PATIENT WAS NOT INJURED. A NEW CATHETER WAS OPENED TO FINISH THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11973163 ↗
• InjuryMay 24, 2021Entrapment of Device; Entrapment of Device

  THE COMPLAINT IS REPORTED AS: "DURING A THROMBECTOMY PROCEDURE THE TREROTOLA DEVICE BEING USED STOPPED ROTATING AND WAS UNABLE TO BE REMOVED FROM THE PATIENT, IT SEEMED TO BE SNAGGED IN THE PATIENTS ARM. THE DEVICE WAS LEFT IN THE PATIENT AND TRANSFERRED TO THE ER. THE BASKET AND DRIVE UNIT REMAINED WITH THE PATIENT. THE UNIT STOPPED, IT IS UNCLEAR IF IT STARTED TO SLOW DOWN PRIOR. DR. REPORTED THE UNIT STOPPED ALL OF A SUDDEN LIKE IT SNAGGED." THE PATIENT UNDERWENT EMERGENCY EXPLORATION OF LEFT UPPER ARM, REMOVAL OF RETAINED TRETOLA CATHETER, AND REPAIR OF CEPHALIC VEIN. FOLLOWING SURGERY, THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION AND REPORTED TO BE "DOING WELL WITHOUT PROBLEMS".

  Patient problems: Foreign Body In Patient

  MAUDE report 11870658 ↗
• InjuryMay 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE COMPLAINT IS REPORTED AS: "SURGEON ADVANCED DEVICE (CATHETER BASKET) INTO THE PATIENT, ONCE DEVICE WAS TURNED ON THE SURGEON PULLED DEVICE BACK SLOWLY TO MASERATE THE CLOT IN THE GRAFT AND AS HE WAS PULLING THE CATHETER BASKET BACK THE LITTLE NOSE PIECE AT THE TOP OF THE DEVICE CAME OFF AND STAYED INSIDE THE PT. THE DOCTOR THEN REMOVED THE DEVICE FROM THE PATIENT AND DEPLOYED A STENT TO 'TRAP' THE LITTLE PIECE THAT CAME OFF INSIDE THE PATIENT SO THAT THERE WAS NO CHANCE OF THAT PIECE FLOATING INTO THE PATIENTS LUNGS OR HEART AREA." IT WAS REPORTED THE PATIENT "IS DOING FINE" AND THE TIP HAS NOT MOVED AFTER STENT PLACEMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 11796916 ↗
• MalfunctionApr 20, 2021Break; Break

  IT WAS REPORTED "PTD BASKET WIRE(S) BROKE DURING THE CASE AT THE TIP OF THE CATHETER. NO PIECES WERE LEFT IN THE PATIENT". NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11698363 ↗
• InjuryMar 22, 2021Material Fragmentation; Material Fragmentation

  THE COMPLAINT IS REPORTED AS: TRYING TO PERFORM A DECLOT AND THE PTD TIP BROKE GOING THROUGH THE SHEATH AND GOT LODGED IN THE FISTULA. TRIED TO SNARE AND WAS UNSUCCESSFUL. A COVERED STENT WAS PLACED TO PREVENT MIGRATION OF THE TIP. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11544140 ↗
• InjuryMar 4, 2021Material Fragmentation; Material Fragmentation

  THE TIP OF THE BASKET BROKE OFF AND LODGED IN THE PATIENT'S VESSEL. THERE WAS NO ATTEMPT TO REMOVE THE BROKEN PIECE. THE PHYSICIAN PLACED A STENT TO HOLD IT IN PLACE. IT WAS REPORTED THE DECLOTTING OF THE PATIENT'S DIALYSIS ACCESS WAS SUCCESSFUL AND THE PATIENT WAS ABLE TO GET A TREATMENT THE NEXT DAY. NO PATIENT COMPLICATION REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11417238 ↗
• MalfunctionMar 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE COMPLAINT IS REPORTED AS: THE BASKET BROKE APART INSIDE OF THE PATIENT WHILE THE PHYSICIAN WAS USING THE DEVICE. THE PHYSICIAN WAS ABLE TO RETRIEVE ANY PIECES WITH A SNARE. NO PATIENT INJURY OR COMPLICATION WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11400313 ↗
• InjuryFeb 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTED "USING TREROTOLA DEVICE ON AN AVF (ARTERIOVENOUS FISTULA), WE WERE WORKING ON THE OUTFLOW, TOOK THE DEVICE OUT TO GET THE CLOT OFF AND WHEN WE TOOK OUR IMAGE WE NOTICED A PERFORATION. EXAMINED THE DEVICE AND THE TIP OF THE CATHETER WAS MISSING. WE USED A STENT TO COVER UP THE PERFORATION." IT WAS REPORTED THE USER HAD TAKEN THE DEVICE OUT TO CLEAN IT AND NOTICED THE TIP WAS OFF. A PICTURE WAS TAKEN USING DIGITAL SUBTRACTION ANGIOGRAPHY AND REVEALED A PERFORATION. A STENT WAS PLACED OVER THE TIP AND PERFORATION. THE PATIENT WAS REPORTED TO BE WELL AND DID NOT HAVE ANY ADDITIONAL COMPLICATIONS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11366862 ↗
• MalfunctionSep 4, 2020Break

  TREROTOLA DEVICE WAS USED FOR THROMBOLYSIS OF A DIALYSIS FISTULA. RADIO-OPAQUE RUBBER TIP (ABOUT 2X4MM) EXITED A DEFECT IN THE FISTULA WALL ASSOCIATED WITH RECENT DIALYSIS PUNCTURES IN A REGION OF STENOSIS. THE TIP BROKE OFF INTO THE SOFT TISSUES, CONFIRMED FLUOROSCOPICALLY AND UPON DEVICE REMOVAL. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO IMMEDIATE SEQUELA. A STENT WAS PLACED TO TREATED THE STENOSIS AND TEAR, FULLY EXCLUDING THE RUBBER TIP FROM THE FISTULA. PATIENT WAS INFORMED. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 10501365 ↗
• MalfunctionJun 4, 2019Material Fragmentation

  THE TIP OF THE TREROTOLA DEVICE FRAGMENTED DURING UTILIZATION OF THE DEVICE. THERE WAS NO ATTEMPT TO REMOVE DUE TO THE VERY SMALL SIZE OF THE FRAGMENT. INVESTIGATION FOLLOW UP WITH PROCEDURALIST. OBJECT KNOWN RETAINED DURING PROCEDURE AND REMAINED IN DUE TO RISK/BENEFIT OF REMOVAL. PROCEDURALIST TO UPDATE DOCUMENTATION TO INCLUDE ADDITIONAL DETAIL. ITEM WAS RETAINED BY DEPT AND FORWARDED. MANUFACTURER RESPONSE FOR CATHETER, EMBOLECTOMY, ARROW (PER SITE REPORTER). THEY HAVE SENT RETURN SHIPPING LABEL AND ARE AWAITING THE ITEM FOR INVESTIGATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 8666320 ↗
• InjuryFeb 12, 2019Break

  DEVICE TIP BROKE OFF DURING PROCEDURE. PATIENT NEEDED SECOND SURGERY TO REMOVE THE FOREIGN BODY. DATES OF USE: (B)(6) 2019 - (B)(6) 2019.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8337025 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K011056. One submission often covers many models, so check the product and lot details in each record.

• Z-0627-2022 · Jan 11, 2022 · Terminated
  Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) C
• Z-0625-2022 · Jan 11, 2022 · Terminated
  Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-C The Arrow-Trerotola Percutaneous Thrombolytic Device (PT
• Z-0626-2022 · Jan 11, 2022 · Terminated
  Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components: PT-65709-C, PT-03009, PT-65709-HS The Arrow-Trerotola Percutane
• Z-0628-2022 · Jan 11, 2022 · Terminated
  5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-03000, PT-65509-S (PT-65509-S2 alternative), PT-01000-D (PT-010
• Z-0623-2022 · Jan 11, 2022 · Terminated
  Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components: PT-12709-CA, PT-12709-C, The Arrow-Trerotola Percutaneous Thro
• Z-0624-2022 · Jan 11, 2022 · Terminated
  Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65709-C, PT-03009, PT-65709-HFS The Arrow-Trerotola Percuta
• Z-0234-2022 · Sep 20, 2021 · Terminated
  Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in c
• Z-0231-2022 · Sep 20, 2021 · Terminated
  Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-12709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in c
• Z-0233-2022 · Sep 20, 2021 · Terminated
  Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-W The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in co
• Z-0232-2022 · Sep 20, 2021 · Terminated
  Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-HFWC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in
• Z-1502-2009 · Feb 11, 2009 · Terminated
  Arrow OTW Percutaneous Thrombolytic Device (PTD) for fistulae and dialysis grafts
• Z-0842-05 · Mar 18, 2005 · Terminated
  The Arrow Trerotola Percutaneous Thrombolytic Device (Product Codes: PT-65709-WC, PT-65709-W, PT-65709-HFWC, and PT-12709-WC) consists of a catheter with an expandable fragmentati