The Recall Desk

Hazard

Device Interaction recalls

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

What the numbers show

Total
25
Critical
1
Severe
2
Most recent
2026-05-06

Of the 25 device interaction recalls we have scored against our rubric, 1 (4%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (8%) 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 device interaction 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.

1–25 of 25

  • HighFDA (Devices)·Z-1948-2026·2026-05-06

    Medtronic Sphere-9 Catheter may cause ventricular fibrillation with Biotronik ICDs

    Medtronic Sphere-9 Catheters used for cardiac ablation may trigger ventricular fibrillation during radiofrequency therapy in patients with Biotronik implantable defibrillators due to an interaction between catheter current flow and a device safety feature.

    Product
    Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0830-2025·2025-01-22

    Impella RP Flex Devices Recalled Due to Optical Sensor Damage Risk

    Abiomed is recalling 2,364 units of the Impella RP Flex with SmartAssist due to risk of optical sensor damage from device interaction. Damage may cause temporary or permanent pump stop and loss of vital monitoring signals.

    Product
    Impella RP Flex with SmartAssist; Product Number: 1000323;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0829-2025·2025-01-22

    Impella RP Heart Pump Recalled Due to Optical Sensor Damage Risk

    Abiomed is recalling 1,560 units of the Impella RP with SmartAssist pump due to risk of optical sensor damage from device interactions. Damaged sensors may cause temporary or permanent pump malfunction.

    Product
    Impella RP with SmartAssist; Product Number: 0046-0035;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2965-2024·2024-09-11

    Impella 5.5 Device Recalled for Missing Labeling on Catheter Interaction

    Abiomed is updating labeling for Impella 5.5 cardiac support pumps to include information about a potential device interaction with Shockwave Coronary IVL Catheters during coronary interventions.

    Product
    Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2964-2024·2024-09-11

    Pump 381 Pump Set lacks labeling for Shockwave catheter interaction risk

    Abiomed's Pump 381 Pump Set labeling lacks information about potential interactions with Shockwave Coronary IVL Catheters during coronary interventions. The manufacturer is updating instructions for use to address this gap.

    Product
    Pump 381 Pump Set (US); Product Code: 1000080;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2958-2024·2024-09-11

    Impella CP Smart Assist Set device interaction with coronary catheters

    The FDA is recalling Impella CP Smart Assist Sets due to a potential device interaction with Shockwave Coronary IVL Catheters used during coronary interventions. Abiomed will update device labeling to inform users about this interaction.

    Product
    Impella CP Smart Assist Set, Canada; Product Code: 0048-0044;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2966-2024·2024-09-11

    Impella 5.5 Pump Labeling Updated Due to Device Interaction

    Abiomed updated Impella 5.5 cardiac pump labeling to document a potential interaction with Shockwave Coronary IVL Catheter during coronary procedures. No injuries have been reported.

    Product
    Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2955-2024·2024-09-11

    Impella CP Smart Assist Set Lacks Labeling for Potential Device Interaction

    Abiomed is updating labeling for the Impella CP Smart Assist Set to warn about a potential interaction with the Shockwave Coronary IVL Catheter when used during coronary interventions. The interaction was previously undocumented in the device instructions.

    Product
    Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2956-2024·2024-09-11

    Impella CP Pump Set Recalled for Potential Device Interaction

    Abiomed is recalling the Impella CP Pump Set due to a potential device interaction with the Shockwave Coronary IVL Catheter during coronary interventions. The manufacturer will update device instructions to address this interaction.

    Product
    Impella CP Pump Set, Japan; Product Code: 0048-0034-JP;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2970-2024·2024-09-11

    Impella 5.5 SmartAssist S2 Labeling Updated for Shockwave Catheter Interaction

    Abiomed is updating labeling for the Impella 5.5 SmartAssist S2 cardiac assist device to address a potential interaction with Shockwave Coronary IVL Catheters during coronary interventions.

    Product
    Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2963-2024·2024-09-11

    Abiomed Impella 5.5 Recall for Potential Shockwave Catheter Interaction

    Abiomed is recalling 2,916 Impella 5.5 units to update labeling regarding a potential interaction with Shockwave Coronary IVL Catheters during coronary interventions.

    Product
    Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2959-2024·2024-09-11

    Abiomed Impella Pump Recall for Potential Shockwave Catheter Interaction

    Abiomed is recalling 43,636 Impella Pumps to update instructions for use regarding a potential interaction with Shockwave Coronary IVL Catheters.

    Product
    Pump 371 14F LT CMR Set; Product Code: 0048-0045;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2961-2024·2024-09-11

    Impella 5.5 with SmartAssist Set: Potential Device Interaction During Coronary Interventions

    Abiomed is updating labeling for Impella 5.5 with SmartAssist Set due to a potential device interaction with Shockwave Coronary IVL Catheter during coronary interventions. The product labeling currently lacks information about this potential interaction.

    Product
    Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2954-2024·2024-09-11

    Impella CP Smart Assist Set: Device interaction safety labeling update

    Abiomed is updating labeling for the Impella CP Smart Assist Set to address a potential device interaction with the Shockwave Coronary IVL Catheter during coronary procedures. No illnesses or injuries have been reported.

    Product
    Impella CP Smart Assist Set, EU; Product Code: 0048-0014;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2969-2024·2024-09-11

    Impella CP Smart Assist Set: Potential Device Interaction with Coronary Catheter

    Abiomed is updating labeling for the Impella CP Smart Assist Set to address a potential device interaction with the Shockwave Coronary IVL Catheter during coronary procedures.

    Product
    Impella CP Smart Assist Set; Product Code: 1000402;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2960-2024·2024-09-11

    Impella CP Cardiac Assist Pump Lacks Shockwave Catheter Interaction Warning

    Abiomed is updating labeling for Impella CP Smart Assist pumps to address a potential interaction with Shockwave Coronary IVL Catheters during coronary interventions. The interaction was previously undocumented in device labeling.

    Product
    Impella CP Smart Assist Set APAC; Product Code: 0048-0047;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2962-2024·2024-09-11

    Impella 5.5 Cardiac Pump Labeling Updated for Device Interaction Risk

    Abiomed is updating documentation for the Impella 5.5 cardiac pump to address a potential device interaction with the Shockwave Coronary IVL Catheter during coronary procedures. The notice affects 21 units distributed worldwide.

    Product
    Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2967-2024·2024-09-11

    Impella CP Smart Assist Set Recalled for Device Interaction Labeling Update

    Abiomed is updating labeling for ImpellaCP SmartAssistSetAPAC to address a potential interaction with Shockwave Coronary IVL Catheters during coronary interventions. Eight units were distributed worldwide.

    Product
    ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2957-2024·2024-09-11

    Abiomed updates Impella CP labeling for Shockwave coronary catheter interaction

    Abiomed is recalling the Impella CP Pump 371 Set due to a potential device interaction with the Shockwave Coronary IVL Catheter. The manufacturer is updating labeling to address this interaction. No illnesses or injuries have been reported.

    Product
    Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2971-2024·2024-09-11

    Impella 5.5 Cardiac Pump Recalled for Undocumented Device Interaction

    Abiomed recalled 413 units of Impella 5.5 with SmartAssist S2 pumps worldwide due to a potential undocumented interaction with Shockwave coronary catheters during cardiac procedures. The company will update product labeling to disclose this interaction.

    Product
    Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2441-2023·2023-08-30

    EMBLEM S-ICD Pulse Generator May Lose Heart Sensing for 24 Hours

    Boston Scientific is recalling 3,856 EMBLEM S-ICD heart devices due to a rare interaction with the LATITUDE communicator that may disable sensing of dangerous heart rhythms for up to 24 hours.

    Product
    EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2116-2023·2023-07-26

    Impella CP cardiac pump recalls due to motor housing interaction with stents

    Abiomed is recalling Impella CP with SmartAssist blood pumps due to risk of motor housing interaction with transcatheter aortic valve replacement devices, which can damage the pump's impeller blades and reduce blood flow.

    Product
    Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0194-2018·2018-03-28

    Monteris Medical Recalls NeuroBlate Systems Due to MRI Interaction

    Monteris Medical Corp is recalling 52 NeuroBlate systems used for MRI-guided neurosurgery due to an unanticipated interaction with 1.5 Tesla MRI systems.

    Product
    MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0132-2013·2012-10-31

    Biosense Webster MobiCath Bi-Directional Guiding Sheath Recalled for Catheter Interaction

    Greatbatch Medical is recalling MobiCath Bi-Directional Guiding Sheaths due to a potential interaction with therapeutic catheters that may cause them to self-advance.

    Product
    Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the cor
    Category
    Medical Device
    Distribution
    Distributed nationwide