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Showing 3681–3700 of 8389 results

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X3 Triathlon CS Insert (Howmedica) – Packaging Breach (2024)

Potential packaging breaches of inner blister and outer sterile blister.

FDAFeb 6, 2024Nationwide• Howmedica Osteonics Corp.

X3 Triathlon CS Insert (Howmedica) – Packaging Breach (2024)

Potential packaging breaches of inner blister and outer sterile blister.

FDAFeb 6, 2024Nationwide• Howmedica Osteonics Corp.

Aveir Leadless Pacemaker (Abbott) – Interference Risk (2024)

Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.

Moderate

FDAFeb 5, 2024Nationwide• Abbott Medical

EasyPoint Needle (Retractable) – Detachment Risk (2024)

The needle cannula of a retractable needle may detach from the needle holder in the patient.

FDAFeb 5, 2024Nationwide• Retractable Technologies, Inc.

Cerebase DA Guide Sheath (Medos) – Fracture Risk (2024)

Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural delay, vascular injury and in extreme rare occasions it may result in embolism.

FDAFeb 2, 2024Nationwide• Medos International Sarl Chemin Blanc 36 Le Locle Switzerland

Visitec Irrigation Handle (Beaver) – Missing Label Info (2024)

Pack and pouch label is missing the manufacturing and expiration date.

FDAFeb 2, 2024Nationwide• Beaver Visitec International, Inc.

Vysis MDM2 FISH Probe Kit (Abbott) – Export Specification Mismatch (2024)

Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.

FDAFeb 1, 2024Nationwide• Abbott Molecular, Inc.

M1000 Wash Station (Abbott) – Export Specification Mismatch (2024)

Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.

FDAFeb 1, 2024Nationwide• Abbott Molecular, Inc.

BD Pyxis Stations (CareFusion) – Software Hang Risk (2024)

Automated dispensing cabinets, running affected software, and Windows 10 operating system may experience the application randomly hang, freeze and/or crash, which may result in delays in medication access, and potential data loss.

FDAFeb 1, 2024Nationwide• CareFusion 303, Inc.

Microalbumin Calibrator (Randox) – Result Misclassification (2024)

Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other methods and may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.

FDAJan 31, 2024Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Trumpet Needle Guide (Technicality) – Ring Detachment (2024)

The Ring on the Trump Needle Guide can detach when excessive pressure is applied.

FDAJan 31, 2024Nationwide• Technicality Inc.

Mini Stick Max 5F Guidewire (Angiodynamics) – Passage Blockage (2024)

Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case

FDAJan 30, 2024Nationwide• Angiodynamics, Inc.

Mini Stick Max 4F Guidewire (Angiodynamics) – Passage Blockage (2024)

Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case

FDAJan 30, 2024Nationwide• Angiodynamics, Inc.

Mini Stick Max 4F Guidewire (Angiodynamics) – Passage Blockage (2024)

Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case

FDAJan 30, 2024Nationwide• Angiodynamics, Inc.

Mini Stick Max 4F Guidewire (Angiodynamics) – Passage Blockage (2024)

Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case

FDAJan 30, 2024Nationwide• Angiodynamics, Inc.

Epix Universal Clip Applier (Applied Medical) – Clip Loading Issue (2024)

Their is the potential that Universal Clip applier may not load clip after the trigger is actuated.

FDAJan 30, 2024Nationwide• Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa

Mini Stick Max 5F Guidewire (Angiodynamics) – Passage Blockage (2024)

Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case

FDAJan 30, 2024Nationwide• Angiodynamics, Inc.

Mini Stick Max 5F Guidewire (Angiodynamics) – Passage Blockage (2024)

Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case

FDAJan 30, 2024Nationwide• Angiodynamics, Inc.

Vantage Elan MRI (Canon) – SFG Value Mismatch (2024)

For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety manual are lower than the correct values, which may cause a patient with an MR conditional device to feel some discomfort during the MR scan.

FDAJan 29, 2024Nationwide• Canon Medical System, USA, INC.

Trinias Angiography System (Shimadzu) – Flat Panel Malfunction (2024)

Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function.

FDAJan 29, 2024Nationwide• SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku

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