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Showing 20201–20220 of 22584 results

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Boston Scientific Marlbourgh: Adapter for ACMI Hysteroscope Catalog Number: 55035

The Hysteroscope Adapter used with the HTA System may disassemble and result in a fluid leak.

FDAJul 28, 2005CA, DE, FL +9 more• Boston Scientific Marlbourgh

Unknown Manufacturer: Encore Reverse Shoulder Prosthesis (RSP), manufactured an...

Incorrect alignment markings or no markings at all on a reverse shoulder prosthesis unit.

FDAJul 28, 2005Nationwide

Philips Medical Systems North America Co. Phillips: Interis Allura BiPlane X-Ray System

1) During positioning of the Lateral Stand the rotation and/or skew movement may travel unexpectedly in opposite direction; 2) movement may be faster than normal speed; 3) the stand may not stop immediately upon release of the joystick.

FDAJul 27, 2005Nationwide• Philips Medical Systems North America Co. Phillips

Unknown Manufacturer: Scanlan Premier Jacobson Micro Scissors, spring style, fl...

Some scissors purchased before May 1, 2005 may not perform properly. They may have a crack in the blade that could break.

FDAJul 27, 2005Nationwide

Terumo Cardiovascular Systems Corp: Terumo/Capiox Cardiovascular Kit containing the CAPIOX Di...

Small cracks in the blood chamber may allow air to enter the rotor of the device

FDAJul 26, 2005AZ, CA, IL +5 more• Terumo Cardiovascular Systems Corp

Alsius Corporation: Alsius CoolGard 3000 Temperature Regulation System

Firm wants users to be aware not to leave the units in standby mode for more than an hour in rooms in excess of 75 F due to risk of an alarm mode being generated due to overheating.

FDAJul 25, 2005Nationwide• Alsius Corporation

Smiths Medical ASD, Inc.: Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheo...

Instructions for use included in the package are for a different tracheostomy tube.

FDAJul 25, 2005Nationwide• Smiths Medical ASD, Inc.

Boston Scientific CRM Corp: VENTAK PRIZM AVT model no. 1900, Atrial and Ventricular T...

Guidant is revising its original recommendations set forth in the 06/17/05 physician letter because new information indicates that one of the original recommendations can increase the risk of a latching event, which may limit available therapy.

FDAJul 25, 2005IN• Boston Scientific CRM Corp

Boston Scientific CRM Corp: CONTAK RENEWAL 3 AVT model numbers M150 and M155; CONTAK ...

Guidant is revising its original recommendations set forth in the 06/17/05 physician letter because new information indicates that one of the original recommendations can increase the risk of a latching event, which may limit available therapy.

FDAJul 25, 2005IN• Boston Scientific CRM Corp

Boston Scientific CRM Corp: VITALITY AVT, model A135 and A155. Implantable Cardiover...

Guidant is revising its original recommendations set forth in the 06/17/05 physician letter because new information indicates that one of the original recommendations can increase the risk of a latching event, which may limit available therapy.

FDAJul 25, 2005IN• Boston Scientific CRM Corp

Boston Scientific Corporation: Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/...

The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

FDAJul 22, 2005Nationwide• Boston Scientific Corporation

Stryker Instruments Div. of Stryker Corporation: Stryker brand Intra-Compartmental (STIC) Pressure Monitor...

The pressure indicated may be inaccurate, and this inaccuracy may be not detectable by the user.

FDAJul 22, 2005Nationwide• Stryker Instruments Div. of Stryker Corporation

Boston Scientific Corporation: Banana Peel Sheaths BP/16/15 Catalog NUmber : 20-610

The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

FDAJul 22, 2005Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Banana Peel Sheaths - 12/30 Catalog Number: 260202

The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

FDAJul 22, 2005Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Vaxcel Chronic Dialysis Catheter - Catheter/PU/14/23/Plas...

The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

FDAJul 22, 2005Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Vaxcel Chest Ports - Standard/T/PU/9/1.8/2.8/63 Catalog N...

The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

FDAJul 22, 2005Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Banana Peel Sheaths BP/11/30 Catalog Number : 20-613

The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

FDAJul 22, 2005Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Vaxcel Chest Ports - Mini/T/PU/7/1.3/2.2/63 Catalog Numbe...

The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

FDAJul 22, 2005Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Banana Peel Sheaths BP/14/30 Catalog Number : 20-615

The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

FDAJul 22, 2005Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Tunneled Central Venous Catheters With PASV Valve Technol...

The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

FDAJul 22, 2005Nationwide• Boston Scientific Corporation

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