Teleflex Medical
FDA adverse event reports naming Teleflex Medical as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: TELEFLEX MEDICAL.
- Total reports
- 29,501
- Deaths
- 105
- Injuries
- 720
- Malfunctions
- 28,552
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Clip, ImplantableFZP4,248
- Stapler, SkinQQS3,700
- Staple, Removable (Skin)GDT2,715
- Tube, Tracheal (W/Wo Connector)BTR2,497
- Applier, Surgical, ClipGDO1,793
- Humidifier, Respiratory Gas, (Direct Patient Interface)BTT1,617
- Nebulizer (Direct Patient Interface)CAF1,170
- Laryngoscope, RigidCCW1,105
- Needle, Hypodermic, Single LumenFMI806
- Tube, Bronchial (W/Wo Connector)BTS734
Recent recalls
- 2022-02-15TerminatedProcess change control
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 Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
The firm received reports indicating PTD tip separation during use.
- 2022-02-15TerminatedProcess change control
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 Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
The firm received reports indicating PTD tip separation during use.
- 2022-02-15TerminatedProcess change control
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 (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
The firm received reports indicating PTD tip separation during use.
- 2022-02-15TerminatedProcess change control
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 Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
The firm received reports indicating PTD tip separation during use.
- 2022-02-15TerminatedProcess change control
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
The firm received reports indicating PTD tip separation during use.
- 2022-02-15TerminatedProcess change control
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-01000-D2 alternative) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
The firm received reports indicating PTD tip separation during use.
- 2022-02-15TerminatedProcess change control
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
The firm received reports indicating PTD tip separation during use.
- 2020-02-07TerminatedDevice Design
HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer kit
There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.
- 2020-02-07TerminatedDevice Design
HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperature Port, REF 2416, humidifier nebulizer kit
There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.
- 2020-02-07TerminatedDevice Design
HUDSON RCI COMFORT FLO Humidification System, REF 2410, humidifier nebulizer kit
There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.
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