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Medical device recalls

Medical device recalls from FDA, newest first.
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2 recalls

Intuitive Surgical Da Vinci PSS SP1098

The Da Vinci Assy, PSS, SP1098 may have a retainer pin issue that can cause uncontrolled motion.

Moderate risk, FDA, Device defect

6 recalls

HeartMate 3 Left Ventricular Assist System Kits, System Controller, and Backup Battery

Due to 11 volt Backup Battery failures.

Moderate risk, FDA, Device defect

STAAR ICL Calculation Software

The STAAR ICL Calculation Software has a coding issue that affects the implant orientation diagram printout.

Moderate risk, FDA, Software defect

Inspire Respiratory Sensing and Stimulation Lead

The Inspire Respiratory Sensing Lead has an incorrect Use By Date, which may lead to unplanned revision surgery.

Moderate risk, FDA, Labeling error

BD Connecta Stopcocks

BD Connecta BD Luer-Lok 360 Stopcocks may have an unstable connection at Port C when used with a plastic luer-lok syringe.

Moderate risk, FDA, Device defect

Merit Medical Systems Splashwire Hydrophilic Guide Wire

The Splashwire Hydrophilic Guide Wire has unsealed portions of pouches.

Moderate risk, FDA, Packaging defect

Beta Bionics iLet Bionic Pancreas

This can lead to hyperglycemia.

Moderate risk, FDA, Software defect

3 recalls

Medline Urethral Catheters and Procedure Kits

Medline urethral catheters and kits may have surface irregularities or connector issues.

Moderate risk, FDA, Quality testing problem

GE HealthCare Giraffe OmniBed Devices

The Giraffe OmniBed has a potential issue with the canopy soffit that could cause patient injury.

Moderate risk, FDA, Device defect

ConMed AirSeal Access Ports and Obturators

ConMed AirSeal Access Port and Obturator may cause overpressure alerts.

Moderate risk, FDA, Device defect

3 recalls

Medtronic O-Arm O2 Imaging System

The O-arm O2 Imaging System may show image artifacts due to a detector panel firmware anomaly.

Moderate risk, FDA, Software defect

ALYON and HarmonyAIR A-Series Surgical Lighting System

The surgical lighting system has light intensity control buttons that may detach.

Moderate risk, FDA, Device defect

HarmonyAIR A-Series Surgical Lighting System

The HarmonyAIR A-Series Surgical Lighting System has paint that may chip or peel on its light heads.

Moderate risk, FDA, Device defect

1 recall

Arrow International Vascular Access and Catheterization Kits

Paracentesis kits contain lidocaine, bupivacaine.

High risk, FDA, Sterility problem

2 recalls

Medline Convenience Kits

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive.

Moderate risk, FDA, Device defect

Automated Impella Controller (AIC)

The Automated Impella Controller has a potential software error when used with left ventricular Impella devices.

High risk, FDA, Software defect

3 recalls

Boston Scientific Orca Single Use Air/Water and Suction Valves

Orca Single Use Air/Water and Suction Valves have a suction button that can stick.

Moderate risk, FDA, Device defect

Merlin Patient Care System (PCS)

Software malfunction may occur during pacing capture threshold test.

Moderate risk, FDA, Software defect

Boston Scientific CSK and TCN Electrodes

Boston Scientific CSK Electrodes may not meet expected performance levels.

Moderate risk, FDA, Device defect

1 recall

Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC)

A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.

Moderate risk, FDA, Device defect

1 recall

EXENT Analyser

It was reported that plates 2 and 3 were marked as passed, although it appeared that QC had not been performed on these plates, despite samples being measured.

Moderate risk, FDA, Device defect

5 recalls

Avanos Medical CORFLO and MIC Safety PEG Kits

Corflo and MIC Safety PEG Kits contain lidocaine hydrochloride injection that was recalled for quality issues.

Moderate risk, FDA, Sterility problem

Mahurkar Elite PASS Trays

Mahurkar Elite PASS Trays are missing the Tegaderm CHG dressing specified in product labeling.

Moderate risk, FDA, Labeling error

Allia Angiographic X-Ray System

The Allia IGS 3 Pulse angiographic X-ray system has an electrical cable issue that could cause electrical shock to service personnel.

Moderate risk, FDA, Device defect

D.O.R.C. TDC VELOCE Two Dimensional Cutters

TDC Veloce cutters have a loose outer knife that can become loose during use.

Moderate risk, FDA, Device defect

Sporetraq Mail-In Spore Testing Service

Due to incorrect incubation process being performed on product.

Moderate risk, FDA, Processing problem

2 recalls

KayserBett IDA Pediatric Care Bed

The pediatric care bed can be operated by a child if not locked, leading to serious injury or death.

High risk, FDA, Device defect

Da Vinci 5

The Da Vinci 5 system tower can unintentionally activate its near infrared handheld camera when turning off illumination.

Moderate risk, FDA, Device defect

3 recalls

Fresenius Kabi Ivenix Infusion System LVP Software

The LVP software of the Ivenix Infusion System can report a false battery-health value and trigger a battery-depletion alarm.

High risk, FDA, Software defect

CareFusion 303 BD Pyxis Medication Cabinets

BD Pyxis medication cabinets have a fingerprint scanner that may overheat and cause first-degree burns.

Moderate risk, FDA, Device defect

B. Braun Spinal Needle Procedure Kits

Spinal Needle procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP, with potential quality issues.

High risk, FDA, Device defect

3 recalls

Arvis Hip & Knee 2.0 and 3.0 Instrument Set

The V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face.

Moderate risk, FDA, Device defect

Shimadzu Digital Angiography and Radiography Systems

Digital Angiography Systems and a Digital Radiography System have electromagnetic contactors that may weld together.

Moderate risk, FDA, Device defect

Daavlin Phothera 200 Phototherapy Devices

Phothera 200 Phototherapy Devices have calibration certificates with reversed outputs.

Moderate risk, FDA, Device defect

4 recalls

PhaseOne Antimicrobial Solution

PhaseOne Antimicrobial Solution has corrosion of its internal spring, which may cause discoloration and trace metals in the solution.

Moderate risk, FDA, Foreign object

CASE v7.0 Cardiac Testing System

The CASE v7.0 Cardiac Testing System can spark at the printer head, potentially causing serious thermal injury.

Moderate risk, FDA, Device defect

Covidien EndoStitch Polysorb Single Use Loading Unit

The Covidien EndoStitch Polysorb Single Use Loading Unit may have holes in its pouch, compromising the sterile barrier.

Moderate risk, FDA, Sterility problem

Philips Azurion 3M12, 3M15, 5M12 and Other Angiography Systems

Philips Azurion systems may show a dark image during Roadmap Pro, not clinically usable.

Moderate risk, FDA, Device defect

5 recalls

Fresenius Kabi Ivenix Infusion System (IIS), Large Volume Pump

The Ivenix Large Volume Pump can be damaged by dropping or jarring, causing unintended touchscreen behavior.

High risk, FDA, Device defect

Covidien Mon-a-Therm Temperature Probes and Esophageal Stethoscope

Covidien Mon-a-Therm temperature probes lack FDA clearance.

Moderate risk, FDA, Unapproved product

Exacta Mix Vented Micro-Volume Inlet

Exacta Mix Vented Micro-Volume Inlet tubing sets may contain incorrect filters, causing reduced flow and clinical effects.

Moderate risk, FDA, Device defect

Becton Dickinson & Company BD Spinal Trays

BD Spinal Trays with Quincke or Whitacre needles have quality deficiencies related to acceptance testing.

High risk, FDA, Device defect

Fresenius Kabi Ivenix Infusion System Large Volume Pump

The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS) has a cassette loading lever that can break.

Moderate risk, FDA, Device defect

4 recalls

Medtronic 1x4 and 2x4 Pocket Adaptor Kit for Deep Brain Stimulation

The Medtronic Pocket Adaptor Kits are labeled with incorrect Use-By-Dates.

Moderate risk, FDA, Labeling error

Medline Anesthesia and Spinal Trays

Medline kits containing Huons Bupivacaine in Dextrose Injection have quality issues, including data integrity concerns and efficacy complaints.

High risk, FDA, Device defect

Philips Azurion and Allura Systems

The Azurion system may show decreased performance as it ages, potentially causing loss of imaging functionality.

Moderate risk, FDA, Device defect

Abiomed Impella Controllers

The Automated Impella Controller has alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing.

High risk, FDA, Device defect

1 recall

HydroMARK Breast Biopsy Site Marker

The HydroMARK Breast Biopsy Site Marker has incorrect inner package labeling.

Moderate risk, FDA, Labeling error

1 recall

Omnipod 5 Pods, Omnipod DASH Pod, and Omnipod (Eros) Pod

Omnipod insulin pods may leak insulin due to cannula damage, causing under-delivery and high blood glucose.

High risk, FDA, Device defect

1 recall

Automated Impella Controller (AIC)

The Automated Impella Controller may interrupt motor control, have startup issues, or boot up improperly.

High risk, FDA, Device defect