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Showing 5741–5760 of 8393 results

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Novafil Polybutester Suture (Unknown) – Sterile Barrier Breach (2022)

Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

FDADec 2, 2022Nationwide

EdgeAhead Stiletto Knife (Beaver Visitec) – Packaging Sterility (2022)

Packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility and may lead to infection

FDANov 30, 2022Nationwide• Beaver Visitec International, Inc.

Source Administration Set (Bayer) – Black Specks on Needles (2022)

Black specks may be present on the packaged needles

Low

FDANov 30, 2022Nationwide• Bayer Medical Care, Inc.

HeartWare HVAD Pump Kit (Heartware) – Driveline Cover Hardening (2022)

Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.

FDANov 29, 2022Nationwide• Heartware, Inc.

HeartWare HVAD Pump Kit (Heartware) – Driveline Cover Hardening (2022)

Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.

FDANov 29, 2022Nationwide• Heartware, Inc.

HeartWare Model 1101 (Heartware) – Driveline Cover Hardening (2022)

Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.

FDANov 29, 2022Nationwide• Heartware, Inc.

HeartWare HVAD Pump Kit (Heartware) – Driveline Cover Hardening (2022)

Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.

FDANov 29, 2022Nationwide• Heartware, Inc.

Acutrak Fusion Device (Acumed) – Pre-Market Clearance Issue (2022)

Distribution without Pre-Market Clearance

FDANov 29, 2022Nationwide• Acumed LLC

Dual-Trak Clavicle Screws (Acumed) – Pre-Market Clearance Issue (2022)

Distribution without Pre-Market Clearance

FDANov 29, 2022Nationwide• Acumed LLC

AcuTwist Compression Screws (Acumed) – Pre-Market Clearance Issue (2022)

Distribution without Pre-Market Clearance

FDANov 29, 2022Nationwide• Acumed LLC

HeartWare Model 1102 (Heartware) – Driveline Cover Hardening (2022)

Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.

FDANov 29, 2022Nationwide• Heartware, Inc.

Acutrak 2 (Acumed) – Pre-Market Clearance Issue (2022)

Distribution without Pre-Market Clearance

FDANov 29, 2022Nationwide• Acumed LLC

OSS Modular Arthrodesis Nail (Biomet) – Missing Locking Bolts (2022)

Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement

FDANov 29, 2022Nationwide• Biomet, Inc.

HeartWare Model 1100 (Heartware) – Driveline Cover Hardening (2022)

Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.

FDANov 29, 2022Nationwide• Heartware, Inc.

Tonsillectomy Tray (DeRoyal) – Surgical Pack Issue (2022)

DeRoyal is recalling certain lots of surgical procedure pack products that contain a ConMed Foot Controlled Electrosurgical Suction Coagulator. The recall is due to ConMed receiving reports that the suction ports may be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use.

FDANov 28, 2022IN, SC, VA• DeRoyal Industries Inc

SARS-CoV-2 Test Kit (Universal Meditech) – Unauthorized Distribution (2022)

Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization.

FDANov 28, 2022Nationwide• Universal Meditech Inc.

Alinity Reaction Vessels (Abbott) – Optical Contaminant (2022)

Reaction vessels may contain a potential contaminant that could affect their optical performance.

FDANov 24, 2022IL, MN, MO +8 more• Abbott Laboratories

Revaclear 400 Dialyzer (Baxter) – Gasket Twisting Issue (2022)

Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer

FDANov 23, 2022Nationwide• Baxter Healthcare Corporation

Luminos dRF Max (Siemens) – Fluoroscopic Display Error (2022)

Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube.

FDANov 23, 2022Nationwide• Siemens Medical Solutions USA, Inc

Revaclear 400 Dialyzer (Baxter) – Polyurethane Displacement (2022)

Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak

FDANov 23, 2022Nationwide• Baxter Healthcare Corporation

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