The Recall Desk

Hazard

Deployment Failure recalls

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

What the numbers show

Total
52
Critical
7
Severe
9
Most recent
2026-07-08

Of the 52 deployment failure recalls we have scored against our rubric, 7 (13%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 9 (17%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all deployment failure 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 52

  • SevereFDA (Devices)·Z-2672-2026·2026-07-08

    GORE TAG Thoracic Branch Endoprosthesis Side Branch Component Recall

    W. L. Gore & Associates is recalling 467 GORE TAG Thoracic Branch Endoprosthesis Side Branch Components worldwide due to risk of catheter separation during deployment.

    Product
    GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and Canada: TSB080806A, TSB081006A, TSB081206A, TSB081506A, TSB081706A, TSB121506A, TSB121706A, TSB122006A EMEA Countries, Australia, New Zealand:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2330-2026·2026-06-17

    CGuard Prime 10mm by 40mm carotid stents may fail deployment

    CGuard Prime Carotid Stent Systems, 135 cm with a 10 mm x 40 mm stent, are being recalled because the delivery system may meet high resistance or fail to deploy the stent.

    Product
    CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2326-2026·2026-06-17

    CGuard Prime 8mm carotid stent systems may resist or fail deployment

    CGuard Prime Carotid Stent Systems, 135 cm with an 8 mm x 40 mm stent, are being recalled because the delivery system may meet high resistance or fail to deploy the stent.

    Product
    Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2328-2026·2026-06-17

    CGuard Prime 9mm carotid stent systems may resist or fail deployment

    CGuard Prime Carotid Stent Systems, 135 cm with a 9 mm x 40 mm stent, are being recalled because the delivery system may meet high resistance or fail to deploy the stent.

    Product
    Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2329-2026·2026-06-17

    CGuard Prime 10mm by 30mm carotid stents may fail deployment

    CGuard Prime Carotid Stent Systems, 135 cm with a 10 mm x 30 mm stent, are being recalled because the delivery system may meet high resistance or fail to deploy the stent.

    Product
    CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2325-2026·2026-06-17

    CGuard Prime 8mm by 30mm carotid stents may fail deployment

    CGuard Prime Carotid Stent Systems, 135 cm with an 8 mm x 30 mm stent, are being recalled because the delivery system may meet high resistance or fail to deploy the stent.

    Product
    Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2327-2026·2026-06-17

    CGuard Prime 9mm by 30mm carotid stents may fail deployment

    CGuard Prime Carotid Stent Systems, 135 cm with a 9 mm x 30 mm stent, are being recalled because the delivery system may meet high resistance or fail to deploy the stent.

    Product
    CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2160-2026·2026-06-03

    RelayPro thoracic stent-graft clasp may not release from delivery system

    The RelayPro Thoracic Stent-Graft System is subject to a labeling update concerning proximal clasp disconnection from the outer control tube, which may prevent release of the graft.

    Product
    RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-32U 28-N4-32-209-28U 28-N4-32-209-32U 28-N4-32-259-32U 28-N4-34-109-34U 28-N4-34-154-30U 28-N4-34-154-34U 28-N4-34-209-30U 28-N4-34-209-34U 28-N4-34-259-34U 28-
    Category
    Medical Device
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-1163-2026·2026-02-11

    HOT AXIOS 20mm stents recalled over deployment and expansion problems

    Boston Scientific is recalling 588 units of the HOT AXIOS Stent and Electrocautery-Enhanced Delivery System, 20mm x 10mm after increased reports of stent deployment and expansion issues.

    Product
    *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1158-2026·2026-02-11

    AXIOS stents recalled over deployment and expansion problems during placement

    Boston Scientific is recalling 557 AXIOS Stent and Electrocautery-Enhanced Delivery Systems, 20mm x 10mm, after increased reports of stent deployment and expansion issues.

    Product
    AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1159-2026·2026-02-11

    AXIOS 6mm stents recalled over deployment and expansion problems

    Boston Scientific is recalling 39 AXIOS Stent and Electrocautery-Enhanced Delivery Systems, 6mm x 8mm, after increased reports of stent deployment and expansion issues.

    Product
    AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1162-2026·2026-02-11

    HOT AXIOS 8mm stents recalled over deployment and expansion problems

    Boston Scientific is recalling 150 HOT AXIOS Stent and Electrocautery-Enhanced Delivery Systems, 8mm x 8mm, after increased reports of stent deployment and expansion issues.

    Product
    *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1160-2026·2026-02-11

    AXIOS 8mm stents recalled over deployment and expansion problems

    Boston Scientific is recalling 59 units of the AXIOS Stent and Electrocautery-Enhanced Delivery System, 8mm x 8mm after increased reports of stent deployment and expansion issues.

    Product
    AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1161-2026·2026-02-11

    HOT AXIOS stents recalled over deployment and expansion problems

    Boston Scientific is recalling 266 HOT AXIOS Stent and Electrocautery-Enhanced Delivery Systems, 6mm x 8mm, after increased reports of stent deployment and expansion issues.

    Product
    HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0108-2026·2025-10-22

    Flow diverter devices recalled over tantalum defect affecting vessel wall apposition

    MicroVention is recalling 467 FRED and FRED X flow diverters over a manufacturing issue with tantalum length or attachment that may leave the device incompletely open or poorly apposed.

    Product
    Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED5514, FRED3536, FRED3511, FRED5014, FRED3516, MV-F451827; FRED X 27, REF: XFRED4017-MVE, XFRED4528-MVE, MV-F501427X, XFRED4518-MVE, XFRED5526-MVE, XFRED4539-MVE,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2586-2025·2025-09-24

    Heartstring III seal systems recalled over failures to load, deploy and seal

    Heartstring III Proximal Seal Systems, model HS-3045, are recalled after three failure modes were identified, including failure of the deployed seal to provide adequate hemostasis. 126 units are affected.

    Product
    Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2587-2025·2025-09-24

    Heartstring III 3.8 mm seal systems recalled over three identified failure modes

    Heartstring III Proximal Seal Systems, 3.8 mm, are recalled after three failure modes were identified, including failure of the deployed seal to provide adequate hemostasis. 28,331 units are affected.

    Product
    Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2588-2025·2025-09-24

    Heartstring III 4.3 mm seal systems recalled over loading and deployment failures

    Heartstring III Proximal Seal Systems, 4.3 mm, are recalled after three failure modes were identified, including failure of the deployed seal to provide adequate hemostasis. 12,471 units are affected.

    Product
    Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1070-2025·2025-02-26

    Vascular Tack Endovascular System recalled for deployment and migration risks

    Spectranetics' Intact Vascular Tack Endovascular System may fail to deploy properly or migrate in blood vessels, potentially causing ischemia and requiring additional intervention.

    Product
    Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm, REF: 154150041; Tack, 4F Gen 1.5, 150cm CE, REF: 154150042; Tack, 4F Gen 1.5, 90cm CE, REF: 154090042 (6F, 3.5 - 6.0mm), 135cm, REF: 15613
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1121-2025·2025-02-19

    LVIS Intraluminal Support Device May Fail to Deploy Properly

    MicoVention Terumo LVIS stent devices may fail to advance from the introducer due to PTFE material on the stent loop. Eleven units (Lot 0000456768) distributed in China are affected.

    Product
    MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297. The intended purpose of the LVIS Device is to serve as a stent-assisted coiling (SAC) device providing support to the embolic coils used in the treatment of
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·24V856000·2024-11-12

    2025 BMW X3 Head Curtain Air Bag Defect Recall

    BMW is recalling certain 2025 X3 30 xDrive vehicles because the right-side head curtain air bag may have been assembled incorrectly, risking delayed or improper deployment in a crash.

    Product
    BMW — BMW X3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0291-2024·2023-11-22

    Atrium Advanta V12 Covered Stent System Recalled for Weld Failure

    Atrium Medical Corporation is recalling 141 units of the Advanta V12 Covered Stent System due to a balloon-to-catheter weld failure that may cause loss of balloon pressure during stent deployment. Affected units were distributed to eleven countries.

    Product
    Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of the iliac andrenal arteries. Renal approval includes 5mm, 6mm and 7mm diameter Advanta V12 covered stent sizes. In Canada, the Advanta V12 Covered Stent indicat
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1987-2023·2023-06-28

    Olympus QUICKCLIP PRO hemostatic clips recalled for deployment failures

    Olympus is recalling 340 QUICKCLIP PRO hemostatic clips used in gastrointestinal endoscopy due to reports of deployment failures during procedures, including clips that fail to open, close, or detach properly.

    Product
    Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1988-2023·2023-06-28

    Olympus QUICKCLIP PRO hemostatic clips recalled for deployment failures

    Olympus is recalling QUICKCLIP PRO hemostatic clips due to deployment failures that could prevent proper function during GI procedures. Clip arms may fail to operate or clips may detach prematurely from tissue.

    Product
    Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1990-2023·2023-06-28

    Hemostatic Clip Device Recalled Due to Deployment Failures

    Olympus recalls QUICKCLIP PRO hemostatic clips nationwide due to reported malfunction during clinical procedures, where clips fail to open, close, or detach from tissue as intended.

    Product
    Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.B
    Category
    Medical Device
    Distribution
    Distributed nationwide