The Recall Desk

Hazard

Procedural Complication recalls

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

What the numbers show

Total
8
Critical
0
Severe
4
Most recent
2026-08-19

Of the 8 procedural complication recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (50%) 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 procedural complication 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.

1–8 of 8

  • HighFDA (Devices)·Z-2931-2026·2026-08-19

    Philips Azurion Rystem X-Ray System Software Recall for Image Quality Issues

    Philips is recalling Azurion Rystem X-ray systems due to software defects that may degrade image quality or lose geometry movements, potentially delaying therapy or causing procedural complications.

    Product
    Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*, 722281*, and 722282* (*These models are distributed only in China), with Software Version Number R2.2.10 and R2.1.10*
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1819-2022·2022-10-05

    VenaCure EVLT procedure kit fiber component fails dimensional specification

    Angiodynamics is recalling 40 VenaCure EVLT procedure kit units with fiber components that fail dimensional specifications. The defect may damage the sheath, necessitating removal from the patient and potential additional surgical intervention.

    Product
    VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box contains 5 Procedure Kits). For use in the treatment of varicose veins.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0927-2022·2022-04-27

    Medtronic Harmony Delivery Catheter System Recalled Over Equipment Failure Risk

    Medtronic is recalling 1,483 Harmony Delivery Catheter Systems due to potential capsule bond failure during pulmonary valve replacement procedures. The FDA has classified this as a Class I recall affecting devices distributed in the US and Canada.

    Product
    Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1940-2020·2020-05-20

    Cook Inc. Recalls Formula 418 Renal Balloon-Expandable Stents

    Cook Inc. is recalling 10 Formula 418 Renal Balloon-Expandable Stents because the stent may dislodge from the delivery system before deployment.

    Product
    Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56611 Balloon-expandable stent made of 316L stainless steel with a slotted tube configuration. It is pre-mounted on an over-the-wire balloon catheter, which serves as the delivery system. Th
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1574-2020·2020-04-01

    Bard Groshong Dual-Lumen Catheters Recalled for Incorrect Tunneler Tip

    Bard Peripheral Vascular Inc is recalling 650 Groshong 9.5 Dual-Lumen CV Catheters because they may contain an incorrect tunneler barb tip, potentially prolonging surgical operations.

    Product
    1. Groshong 9.5 Dual-Lumen CV Catheter, Ref: 7726950, UDI: (01)00801741041570; 2. Groshong 9.5 F Dual-Lumen CV Catheter, REF: 7726954, UDI: (01)00801741041587
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2224-2019·2019-08-28

    Edwards SAPIEN 3 Ultra Heart Valve System Recalled for Burst Balloons

    Edwards Lifesciences is recalling 362 units of the SAPIEN 3 Ultra Transcatheter Heart Valve System due to reports of burst balloons that complicate device retrieval.

    Product
    Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 9630TF20 UDI:00690103201239
    Category
    Medical Device
    Distribution
    12 states
  • SevereFDA (Devices)·Z-2225-2019·2019-08-28

    Edwards SAPIEN 3 Ultra Heart Valve System Recalled for Burst Balloons

    Edwards Lifesciences is recalling SAPIEN 3 Ultra Transcatheter Heart Valve Systems due to reports of burst balloons that caused significant difficulty retrieving the device during procedures.

    Product
    Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 9630TF23 UDI:00690103201246
    Category
    Medical Device
    Distribution
    12 states
  • SevereFDA (Devices)·Z-2227-2019·2019-08-28

    Edwards SAPIEN 3 Ultra Heart Valve System Recalled for Burst Balloons

    Edwards Lifesciences is recalling SAPIEN 3 Ultra Transcatheter Heart Valve Systems because burst balloons can make it difficult to remove the device from patients.

    Product
    Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260
    Category
    Medical Device
    Distribution
    12 states