The Recall Desk

Hazard

Tip Separation recalls

17 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
17
Critical
1
Severe
10
Most recent
2026-08-26

Of the 17 tip separation recalls we have scored against our rubric, 1 (6%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 10 (59%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all tip separation recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–17 of 17

  • HighFDA (Devices)·Z-2978-2026·2026-08-26

    Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus Recall

    Boston Scientific is recalling ENROUTE Transcarotid Neuroprotection System Plus catheters due to a potential for arterial sheath tip separation during use.

    Product
    Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2977-2026·2026-08-26

    Boston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation

    Boston Scientific is recalling ENROUTE Transcarotid Neuroprotection Systems due to a potential for arterial sheath tip separation or partial tip separation during use.

    Product
    Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1902-2025·2025-06-25

    Cook Beacon Tip Angiographic Catheters Recalled for Tip Separation Risk

    Cook Incorporated is recalling specific lots of Beacon Tip 5.0 Fr Angiographic catheters due to the risk that the catheter tip may separate during use. The affected catheters were distributed worldwide.

    Product
    Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are available in various configurations. Configurations include different shaft lengths and tip curves and some catheters are manufactured with a hydrophilic coati
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1610-2024·2024-05-01

    Route 92 Medical Access System Recalled for Distal Tip Separation

    Route 92 Medical's Full Length 070 Access System (REF 7002) is recalled due to potential distal tip separation at the proximal marker band of the delivery catheters. This FDA Class I recall affects a device used in neurovasculature interventions distributed across the US and New Zealand.

    Product
    Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
    Category
    Medical Device
    Distribution
    30 states
  • SevereFDA (Devices)·Z-1613-2024·2024-05-01

    Route 92 Medical delivery catheter recalled due to tip separation risk

    Route 92 Medical is recalling Tenzing 7 delivery catheters because the distal tip may separate from the proximal marker band. The affected units were distributed across the US and New Zealand.

    Product
    Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.
    Category
    Medical Device
    Distribution
    30 states
  • SevereFDA (Devices)·Z-0625-2022·2022-02-23

    Arrow-Trerotola Dialysis Catheter Recalled for Tip Separation During Use

    Arrow-Trerotola Over-The-Wire PTD catheters used in dialysis procedures are being recalled due to reports of tip separation during use. The FDA classified this as a Class I recall affecting 1,265 units worldwide.

    Product
    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 nati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0628-2022·2022-02-23

    Arrow-Trerotola Thrombolytic Catheter Kits Recalled for Tip Separation During Use

    Teleflex Medical is recalling 5,530 Arrow-Trerotola PTD catheter kits due to reports of tip separation during use. The hazard could prevent the device from functioning properly to remove blood clots from dialysis access grafts.

    Product
    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 conjun
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0629-2022·2022-02-23

    Arrow-Trerotola Percutaneous Thrombolytic Device Set Tip Separation Recall

    Teleflex Medical Inc. is recalling Arrow-Trerotola PTD catheter sets due to reported tip separation during use. The device is used for mechanical declotting of vascular access fistulae and grafts.

    Product
    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) fist
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0623-2022·2022-02-23

    Arrow-Trerotola Thrombolytic Device Tip Separation During Use Recalled

    Teleflex Medical is recalling Arrow-Trerotola PTD kits due to reports of tip separation during use. The affected device is used for declotting dialysis grafts and fistulae.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1847-2020·2020-05-13

    Applied Medical Recalls Bard Embolectomy Catheters Due to Tip Separation

    Applied Medical Resources Corp is recalling Bard Embolectomy Catheters because the tips may separate during use, posing a risk of dislodgement in patients.

    Product
    Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H699CE0340DR10R; CE0380DR/(01)H699CE0380DR10V; CE0440DR/(01)H699CE0440DR10S; CE0480DR/(01)H699CE0480DR10W; CE0540DR/(01)H699CE0540DR10T; CE0580DR/(01)H699CE0580DR10X; CE0680DR/(01)H699CE0680DR10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1848-2020·2020-05-13

    Applied Medical Dual Lumen Graft Cleaning Catheter Recall for Tip Separation

    Applied Medical Resources Corp is recalling 28,799 Dual Lumen Graft Cleaning Catheters due to reports of tip separation during use, which may expose patients to unintended dislodgement.

    Product
    Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic, REF: A4GW6, 5F X 60cm, 9mm, Sterile EO, CE, UDI: (01)00607915111175
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1846-2020·2020-05-13

    Applied Medical Recalls Python Embolectomy Catheters Due to Tip Separation

    Applied Medical Resources Corp is recalling Python Embolectomy Catheters because the tips may separate during use, posing a risk of unintended dislodgement in patients.

    Product
    Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407; A4E02/(01)00607915113414; A4E03/(01)00607915113421; A4E04/(01)00607915113438; A4E05/(01)00607915113445; A4E06/(01)00607915113452; A4E08/(01)00607915113476; A4E09/(01)00607915113483
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1567-2020·2020-04-08

    LeMaitre Embolectomy Catheter Recall for Deflation Failure and Tip Separation

    LeMaitre Vascular is recalling 5F Plus Over the Wire Embolectomy Catheters due to reports of deflation failure that may lead to tip separation.

    Product
    LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over the Wire Embolectomy Catheter is indicated for use in the removal of emboli and thrombi during embolectomy and/or thrombectomy. It can also be used for cathe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0228-2015·2014-11-26

    Monteris Medical Recalls FullFire Diffusing Tip Laser Probes Due to Tip Separation

    Monteris Medical is recalling 133 FullFire Diffusing Tip Laser Probes because the distal sapphire tip may separate from the probe.

    Product
    FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DTP401-01, DTP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal ther
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-1466-2014·2014-04-23

    Edwards Lifesciences Recalls Fem-Flex II Arterial Cannulae Due to Tip Separation

    Edwards Lifesciences is recalling 13,115 Fem-Flex II Arterial and femoral Cannulae because the dilator tips may separate. The recall covers units distributed nationwide and to foreign, government, and military consignees.

    Product
    Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French, models: FEMII016A, FEMII016AS, FEMII018A, FEMII018AS, FEMII020A, and FEMII020AS.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1467-2014·2014-04-23

    Edwards Lifesciences Recalls Fem-Flex II Arterial Cannulae Due to Tip Separation

    Edwards Lifesciences is recalling 28,885 Fem-Flex II Arterial and Femoral Cannulae because the dilator tips may separate.

    Product
    Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae with Duraflo Coating, arterial cannula sizes 16, 18 and 20 French, Models DFEMII016AS, DFEMII018AS, DFEMII020AS, DIIFEMII016A, DIIFEMII018A, and DIIFEMII020A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1176-2014·2014-03-19

    Biosense Webster Recalls PentaRay Nav Catheters Due to Tip Separation Risk

    Biosense Webster is recalling PentaRay Nav and PentaRay Nav ECO catheters because the distal tip may separate from the shaft.

    Product
    PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. D128201, D128202, D128204, D128205, D128207, D128208, D128210, D128211. The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiologica
    Category
    Medical Device
    Distribution
    Distributed nationwide