Covidien LLC
FDA adverse event reports naming Covidien LLC as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: COVIDIEN LLC.
- Total reports
- 2,759
- Deaths
- 37
- Injuries
- 467
- Malfunctions
- 2,249
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
- Catheter, Hemodialysis, ImplantedMSD619
- Shunt, Central Nervous System And ComponentsJXG473
- Catheter, Peritoneal, Long-Term IndwellingFJS224
- OximeterDQA183
- Electrosurgical, Cutting & Coagulation & AccessoriesGEI138
- Catheter, Hemodialysis, Non-ImplantedMPB126
- Laryngoscope, RigidCCW125
- Stimulator, NerveETN121
- Bur, Ear, Nose And ThroatEQJ103
- Index-Generating Electroencephalograph SoftwareOLW76
Recent recalls
- 2026-07-02Open, ClassifiedLabeling Change Control
Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidien Shiley Disposable Decannulation Plug are: Product Number / UDI-DI code 4DCFN 10884522006576 4DCFS 10884522006583 4DFEN 10884522006606 6DCFN 10884522006613 6DCFS 10884522006620 6DFEN 10884522006644 8DCFN 10884522006651 8DCFS 40884522006690 8DFEN 10884522006675 10DCFN 20884522006535 10DCFS 10884522006545 10DFEN 10884522006569 The Shiley Disposable Decannulation Plug (DDCP) is a universal size and fits any size DCFS, DCFN, DFEN tracheostomy tube. The red DDCP snaplock connector is used to occlude the proximal end of the outer cannula on the Shiley Tracheostomy Tubes. Refer to Table 1 for model types. The DDCP blocks airflow through the tube and directs breathing through the mouth and nose. The Shiley Tracheostomy Tube and the accessory products are intended for use in providing tracheal access for airway management.
Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.
- 2026-05-29Open, ClassifiedProcess control
COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing tracheal access for airway management. Shiley Tracheostomy Tubes are double cannula tracheostomy tubes with reusable inner cannulae (LPC, FEN, CFS, CFN, LGT) and twist-lock connectors. These Shiley Tracheostomy Tubes have a radiopaque, biocompatible outer cannula constructed of polyvinyl chloride.
Due to customer complaint regarding incorrect display box labeling.
- 2026-05-29Open, ClassifiedUnder Investigation by firm
Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042
Temperature probe devices lack FDA clearance.
- 2026-05-29Open, ClassifiedUnder Investigation by firm
Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044
Temperature probe devices lack FDA clearance.
- 2026-05-29Open, ClassifiedUnder Investigation by firm
Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050
Temperature probe devices lack FDA clearance.
- 2026-03-11Open, ClassifiedUnder Investigation by firm
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 / 10884521856127 Product Number: VSLBASE04P / VITALSYNCSW04 Model / UDI-DI codes: Vital Sync 4.0.0 / 10884521849358 Vital Sync 4.0.2 / 10884521856134 The Vital Sync" Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (EMR) and Clinical Information System (CIS).
Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.
- 2024-06-07Open, ClassifiedNonconforming Material/Component
EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.
- 2023-08-02Open, ClassifiedProcess control
Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-USM
Cell Collection Device may be at increased risk of the sponge detaching from the string during removal of the device from the patient, which could lead to device fragments in patient, obstruction, airway obstruction, secondary intervention, secondary intervention (with the primary procedure), supraglottic airway obstruction, and aspiration.
- 2023-06-26Open, ClassifiedProcess control
Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS
Single ILLUMISITE Platform Console was converted from a 220-240VAC model to a 120VAC configuration using a non-supplied power cord and non-supplied fuses in the field by Medtronic Field Service Engineer.
- 2023-01-12Open, ClassifiedProcess control
COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1
The product is labeled with the incorrect expiration date.
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