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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 481–500 of 615 recalls

Class ICompleted

SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR2.0 SH, 100CM.070", REF SA6AR20SH. for cardiovascular use

Medtronic Vascular

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

March 15, 2019 · DeviceView details →
Class ICompleted

SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL3.0, .070", REF SA6SAL30. for cardiovascular use

Medtronic Vascular

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

March 15, 2019 · DeviceView details →
Class ICompleted

SHERPA NX ACTIVE GUIDING CATHETER, 6F, HSI, 100CM, 070", REF SA6HSI. for cardiovascular use

Medtronic Vascular

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

March 15, 2019 · DeviceView details →
Class ICompleted

SHERPA NX ACTIVE GUIDING CATHETER, 6F ERAD LEFT SH, .070", REF SA6ERADLSH. for cardiovascular use

Medtronic Vascular

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

March 15, 2019 · DeviceView details →
Class ICompleted

SHERPA NX ACTIVE GUIDING CATHETER, 6F, RBU3.5, 100CM, 070", REF SA6RBU35. for cardiovascular use

Medtronic Vascular

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

March 15, 2019 · DeviceView details →
Class ICompleted

SHERPA NX ACTIVE GUIDING CATHETER, 6F RBU4.0 SH, .070", REF SA6RBU40SH. for cardiovascular use

Medtronic Vascular

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

March 15, 2019 · DeviceView details →
Class ICompleted

SHERPA NX ACTIVE GUIDING CATHETER, 6F, NOTO, 100CM, 070", REF SA6NOTO. for cardiovascular use

Medtronic Vascular

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

March 15, 2019 · DeviceView details →
Class ICompleted

SHERPA NX ACTIVE GUIDING CATHETER, 6F, AL1.0 110CM .070", REF SA6AL10A. for cardiovascular use

Medtronic Vascular

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

March 15, 2019 · DeviceView details →
Class ICompleted

SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR1.0 100CM.070", REF SA6AR10. for cardiovascular use

Medtronic Vascular

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

March 15, 2019 · DeviceView details →
Class ICompleted

SHERPA NX ACTIVE GUIDING CATHETER, 6F JL4.5, .070", REF SA6JL45. for cardiovascular use

Medtronic Vascular

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

March 15, 2019 · DeviceView details →
Class ICompleted

SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR1.0SH 100CM.070", REF SA6AR10SH. for cardiovascular use

Medtronic Vascular

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

March 15, 2019 · DeviceView details →
Class ICompleted

SHERPA NX ACTIVE GUIDING CATHETER, 6F MP ST, .070", REF SA6MPST. for cardiovascular use

Medtronic Vascular

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

March 15, 2019 · DeviceView details →
Class ICompleted

SHERPA NX ACTIVE GUIDING CATHETER, 6F LCB SH, .070", REF SA6LCBSH. for cardiovascular use

Medtronic Vascular

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

March 15, 2019 · DeviceView details →
Class ICompleted

SHERPA NX ACTIVE GUIDING CATHETER, 6F, RCB SH, 90CM, 070", REF SA6RCBSHD. for cardiovascular use

Medtronic Vascular

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

March 15, 2019 · DeviceView details →
Class ICompleted

SHERPA NX ACTIVE GUIDING CATHETER, 6F, AR2.0, 100CM.070", REF SA6AR20. for cardiovascular use

Medtronic Vascular

There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.

March 15, 2019 · DeviceView details →
Class IICompleted

Rhondium OVC3 One Visit Crown, Model FDI 24/25L USA 12/13L A2 HT, Nonsterile, Rx. The firm name on the label is Rhondium Ltd., Katikati, New Zealand.

RHONDIUM LIMITED

The product was mislabeled with an incorrect expiration date.

January 31, 2019 · DeviceView details →
Class IICompleted

Elekta Unity

Elekta Limited

In rare circumstances, due to reasons such as inadequate hospital facility maintenance, water leakage, and weakening of speaker fixings during the lifetime of the system, the speakers can become dislodged and be pulled into the bore.

January 4, 2019 · DeviceView details →
Class IICompleted

ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.

Implant Direct Sybron Manufacturing, LLC

The peek part was loose on the titanium base of the device which could result in it falling into a patient's mouth during a procedure resulting in aspiration or ingestion.

November 28, 2018 · DeviceView details →
Class IICompleted

ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.

Implant Direct Sybron Manufacturing, LLC

The peek part was loose on the titanium base of the device which could result in it falling into a patient's mouth during a procedure resulting in aspiration or ingestion.

November 28, 2018 · DeviceView details →
Class IICompleted

Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388

Invivo Corporation

The Invasive Blood Pressure (IBP) numeric values will freeze on the display when any of the following functions are performed: change an IBP Site Label using the Site Label icon or the keyboard, activate or deactivate the mean pressure waveform display option (On/Off) using the Invasive Pressure Options Dialog or the keyboard, activate or deactivate the waveform hide option (On/Off) using the Invasive Pressure Options Dialog, activate or deactivate the pressure waveform filter option (On/Off) using the keyboard, and/or perform a Pullback using the Pullback icon or the keyboard

September 24, 2018 · DeviceView details →
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