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Showing 4701–4720 of 8393 results

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Cardiosave Rescue IABP (Datascope) – sensor input failure (2023)

Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector.

FDAJul 31, 2023Nationwide• Datascope Corp.

Cardiosave Rescue IABP (Datascope) – autofill failure (2023)

Users were identifying autofill failure conditions on the devices causing pump stops.

FDAJul 31, 2023Nationwide• Datascope Corp.

EVIS EXERA III Duodenovideoscope (Olympus) – infection risk (2023)

Recent reports of patient infection.

Moderate

FDAJul 27, 2023Nationwide• Olympus Corporation of the Americas

Guider Softip Guide Catheter 8F (Boston Scientific) – tip curve issue (2023)

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

FDAJul 27, 2023Nationwide• Boston Scientific Corporation

Olympus Distal Attachment (Aomori Olympus) – DEHP risk (2023)

The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002

FDAJul 27, 2023Nationwide• Aomori Olympus Co., Ltd. 2 Chome 248-1 Okkonoki Kuroishi Japan

Henke-Ject-2 Syringes (Wolf) – sterile barrier damage (2023)

Sterile barrier might be damaged compromising the sterility of the device.

FDAJul 27, 2023Nationwide• Wolf, Henke Sass, Gmbh Kronenstrasse 16 Tuttlingen Germany

Reusable Distal Attachments (Aomori Olympus) – DEHP risk (2023)

The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002

FDAJul 27, 2023Nationwide• Aomori Olympus Co., Ltd. 2 Chome 248-1 Okkonoki Kuroishi Japan

Tracheal Intubation Fiberscope (Olympus) – endoscope lodging risk (2023)

Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

FDAJul 27, 2023Nationwide• Olympus Corporation of the Americas

Guider Softip Guide Catheter 6F (Boston Scientific) – tip curve issue (2023)

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

FDAJul 27, 2023Nationwide• Boston Scientific Corporation

Guider Softip Guide Catheter 7F (Boston Scientific) – tip curve issue (2023)

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

FDAJul 27, 2023Nationwide• Boston Scientific Corporation

Airway Mobilescope (Olympus) – endoscope lodging risk (2023)

Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

FDAJul 27, 2023Nationwide• Olympus Corporation of the Americas

Bronchovideoscope (Olympus) – endoscope lodging risk (2023)

Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

FDAJul 27, 2023Nationwide• Olympus Corporation of the Americas

PASCAL Transcatheter Valve System (Edwards) – repair resistance (2023)

Due to a manufacturing issue, when using valve repair systems, intended to repair insufficient mitral and/or tricuspid valves, users experienced resistance when attempting to release the implant from the delivery system by rotating the release knob. Additional torque required to initiate rotation of the release wire from the implant, could cause implant rotation or additional implant implantation.

FDAJul 27, 2023Nationwide• Edwards Lifesciences, LLC

Guider Softip Guide Catheter 5F (Boston Scientific) – tip curve issue (2023)

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

FDAJul 27, 2023Nationwide• Boston Scientific Corporation

M/L Taper Hip Prosthesis (Zimmer) – labeling error (2023)

The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.

FDAJul 26, 2023Nationwide• Zimmer, Inc.

OptiStem Rasp Handle (Waldemar Link) – weld crack risk (2023)

A crack in the weld of the rasp handle may lead to a fracture of the frontal sleeve when the rasp is further impacted or extracted. The rasp remains intact. The rasp would need to be pulled out by a clamp leading to a prolongation of surgery or modified surgery

FDAJul 26, 2023GA, IN, TX• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Hamilton-C1 Ventilator (Hamilton) – control board leak (2023)

Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation.

FDAJul 26, 2023Nationwide• Hamilton Medical, Inc.

Hamilton-MR1 Ventilator (Hamilton) – control board leak (2023)

Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation.

FDAJul 26, 2023Nationwide• Hamilton Medical, Inc.

Hamilton-T1 Ventilator (Hamilton) – control board leak (2023)

Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation.

FDAJul 26, 2023Nationwide• Hamilton Medical, Inc.

Hamilton Control Board (Hamilton) – control board leak (2023)

Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation.

FDAJul 26, 2023Nationwide• Hamilton Medical, Inc.

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