ARROW IPN036254Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801902121315), received between Apr 28, 2021 and Apr 28, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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-0625-2022 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2021Break; Break

  THE COMPLAINT IS REPORTED AS: THE DEVICE BROKE APART WHILE BEING REMOVED. A PIECE CAME OFF INTO THE PATIENT, BUT IT WAS ABLE TO BE REMOVED WHILE REMOVING THE WIRE. NO PIECES WERE RETAINED IN THE PATIENT. NO PATIENT INJURY OR HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11736834 ↗

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-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-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-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-0629-2022 · Jan 11, 2022 · Terminated
  Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction
• 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-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-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-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-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