Core noun
Device recall evidence
Joined enrichment rows that support device recall linkage and root-cause wording.
Indexed record set
39,516 evidence rows
-
- Evidence
- device-recall:cfres:206012
- Product
- HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate II LVAS Implant Kit, US REF 106015 3. HeartMate II LVAS Implant Kit, OUS REF 106016 Update (February 14, 2024) HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II LVAS Implant Kit, OUS REF 102139 2. HeartMate II LVAS Implant Kit, US REF 1355 3. HeartMate II LVAS Implant Kit (with RSOC Controller), US REF 103695 4. HeartMate II LVAS Implant Kit (with RSOC Controller), OUS REF 103693 5. HeartMate II LVAS Implant Kit (with Sealed Graft), US REF 104911 6. HeartMate II LVAS Implant Kit (with Sealed Graft), OUS REF 104912 7. HeartMate II LVAS Implant Kit (Used for pump exchange, No Graft) REF 107801 8. HeartMate II LVAS Implant Kit, (EPC), CANADA REF 103695-CAN 9. HeartMate II LVAS Implant Kit (with Sealed Graft), JAPAN REF 104911JPN 10. HeartMate II LVAS Implant Kit (with Pocket System Controller and Sealed Grafts), for geographies outside of US & EU REF 106515OUS HeartMate II Left Ventricular Assist System: The HeartMate II LVAS is an axial-flow, rotary ventricular assist system. One end of the Left Ventricular Assist Device is attached to the apex of the left ventricle; the other end of the device connects to the ascending aorta. The Left Ventricular Assist Device diverts blood from the weakened left ventricle and propels it to the aorta. A small external computer, the System Controller, monitors system operation. A driveline, which passes through the patient s abdomen, connects the implanted pump to the System Controller. The system is powered by a Power Module or Mobile Power Unit (MPU) that is connected to an AC electrical outlet, or by two HeartMate 14 Volt Lithium-Ion batteries.
- Join
- Official recall number ·
Z-1300-2024 - Root cause
- Material/Component Contamination
-
- Evidence
- device-recall:cfres:206373
- Product
- Thermalon Sinus Compress (French), Item Number 24332F
- Join
- Official recall number ·
Z-1360-2024 - Root cause
- Under Investigation by firm
-
- Evidence
- device-recall:cfres:206201
- Product
- MINI STICK MAX 5F X 15 CM STIFF .018 NI/TU NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-776
- Join
- Official recall number ·
Z-1347-2024 - Root cause
- Process control
-
- Evidence
- device-recall:cfres:206163
- Product
- Abbott Point of Care Control Control i-STAT¿ Level 3 1.7 mL
- Join
- Official recall number ·
Z-1315-2024 - Root cause
- Storage
-
- Evidence
- device-recall:cfres:206034
- Product
- HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS 4. HeartMate 3 LVAS Implant Kit, IDE 5. HeartMate 3 LVAS Implant Kit, US 6. HeartMate 3 LVAS Implant Kit, OUS HeartMate 3 Left Ventricular Assist System: The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.
- Join
- Official recall number ·
Z-1301-2024 - Root cause
- Material/Component Contamination
-
- Evidence
- device-recall:cfres:206296
- Product
- Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699
- Join
- Official recall number ·
Z-1369-2024 - Root cause
- Under Investigation by firm
-
- Evidence
- device-recall:cfres:204974
- Product
- MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites
- Join
- Official recall number ·
Z-0675-2024 - Root cause
- Labeling Change Control
-
- Evidence
- device-recall:cfres:203834
- Product
- Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravascular pressure monitoring.
- Join
- Official recall number ·
Z-0409-2024 - Root cause
- Device Design
-
- Evidence
- device-recall:cfres:204213
- Product
- Remington MEDICAL Drainage Bag, REF 600-D;
- Join
- Official recall number ·
Z-0487-2024 - Root cause
- Labeling mix-ups
-
- Evidence
- device-recall:cfres:204146
- Product
- Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS5HND
- Join
- Official recall number ·
Z-0491-2024 - Root cause
- Process control
-
- Evidence
- device-recall:cfres:204172
- Product
- Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7260
- Join
- Official recall number ·
Z-0495-2024 - Root cause
- Process control
-
- Evidence
- device-recall:cfres:204026
- Product
- vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
- Join
- Official recall number ·
Z-0489-2024 - Root cause
- Process control
-
- Evidence
- device-recall:cfres:204437
- Product
- DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR KNEE", PRESS FIT BP MINUS, 8L REF 353-03-108 For the treatment of patients who are candidates for knee arthroplasty per the Indication for use.
- Join
- Official recall number ·
Z-0508-2024 - Root cause
- Labeling Change Control
-
- Evidence
- device-recall:cfres:204251
- Product
- STERILE BETADINE, REF DYNDA1998
- Join
- Official recall number ·
Z-0530-2024 - Root cause
- Under Investigation by firm
-
- Evidence
- device-recall:cfres:204195
- Product
- VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0
- Join
- Official recall number ·
Z-0544-2024 - Root cause
- Under Investigation by firm
-
- Evidence
- device-recall:cfres:204247
- Product
- STERILE STERILE PREP STICK, REF DYNDA1134
- Join
- Official recall number ·
Z-0527-2024 - Root cause
- Under Investigation by firm
-
- Evidence
- device-recall:cfres:203962
- Product
- Compress Device Segmental Anchor Plug, 16 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178406
- Join
- Official recall number ·
Z-0373-2024 - Root cause
- Device Design
-
- Evidence
- device-recall:cfres:203764
- Product
- Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Horizon Adult Resuscitator REF #s: 9122HZ, HZI9000, HZI9108, 9106HZ, 9110HZ, 9120HZ, 9111HZ, 9100HZ, 9105HZ, 9108HZ, 9006HZ, 9002HZ; 2. Horizon Infant Resuscitator REF #s: 6112HZ, 6123HZ, 6125HZ, 6200HZ, 6106HZ, 6118HZ, 6107HZ, 6013HZ, 6117HZ, 6116HZ, 6019HZ, HZI6000, 6009HZ; 3. Horizon Pediatric Resuscitator REF #s: 8106HZ, 8119HZ, 8115HZ, 8107HZ, 8010HZ, 8004HZ, 8105HZ, 8113HZ, 8109HZ, 8116HZ, 8003HZ, HZI8100;
- Join
- Official recall number ·
Z-0363-2024 - Root cause
- Device Design
-
- Evidence
- device-recall:cfres:203766
- Product
- Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. SafeSpot Infant Resuscitator REF #s: SS3200OBPC-T, SS3204MB-D12, SS3200MB-2, SS3200MB-D1, SS3200OBP, SS3200MB-MMC, SS3200MBP-M00, SS3200MB-PW, SS3200MBP-2I, SS3200MBF-2, SS3204MBF-2, SS3200MB- PWS10, SS3206MCP-S1, SS3204MB, SS3204MC-P2, SS3200MB, SS3200MBP-2, SS3200MBF, SS3200MB-I, SS3200MBP, SS3200OB, SS3200MC, SS3200MC-P2; 2. SafeSpot Safe Spot Bag, D1 Mask with Inflation Bag Reservoir, Manometer, PEEP Valve, and 40cm Pop-Off REF # PRO-1927.
- Join
- Official recall number ·
Z-0365-2024 - Root cause
- Device Design
-
- Evidence
- device-recall:cfres:203829
- Product
- Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 plus), 08105618190 - (cobas c 303 and 503)
- Join
- Official recall number ·
Z-0352-2024 - Root cause
- Under Investigation by firm
-
- Evidence
- device-recall:cfres:204465
- Product
- RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low Profile Primary Guide is an instrument used with a power system to compress the RibLoc plates onto the bone, determine the length of the screw to install, locate the position of the holes to drill, and provide proper orientation for the installation of the screws.
- Join
- Official recall number ·
Z-0618-2024 - Root cause
- Unknown/Undetermined by firm
-
- Evidence
- device-recall:cfres:204906
- Product
- Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.
- Join
- Official recall number ·
Z-0636-2024 - Root cause
- No Marketing Application
-
- Evidence
- device-recall:cfres:204552
- Product
- Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 2000342
- Join
- Official recall number ·
Z-0655-2024 - Root cause
- Process control
-
- Evidence
- device-recall:cfres:204902
- Product
- PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG0404: 4 X 4 CM US, TS; c) SPG0608: 6 X 8 CM US, TS; d) SPG0814: 8 X 14 CM US, TS; e) PC1016SNBIO: 10X16 CM US; f) PC0404SNBIO: 4X4 CM US; g) PC0608SNBIO: 6X8 CM US; h) PC0814SNBIO: 8X14 CM US
- Join
- Official recall number ·
Z-0668-2024 - Root cause
- Under Investigation by firm
-
- Evidence
- device-recall:cfres:204536
- Product
- Vascu-Guard Peripheral Vascular Patch (US), Product Codes: a) VG0108: 0.8 X 8 CM US, TS; b) VG0110: 1 X 10 CM US, TS; c) VG0106: 1 X 6 CM US, TS; d) VG0209: 2 X 9 CM US, TS
- Join
- Official recall number ·
Z-0666-2024 - Root cause
- Under Investigation by firm