Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 96 of 138
Atrium Medical Corporation
Class II Terminated
Atrium PVC 10 Fr Straight Thoracic Catheter Code Number: 8010
Reason: Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two (2)
Z-1222-2017 February 22, 2017 Hudson, NH
Merge Healthcare, Inc.
Class II Terminated
Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure
Reason: There is a potential connection issue when powering up the Merge Hemo Record Station and the Hemo Monitor does not communicate with the Client PC.
Z-1091-2017 February 1, 2017 Hartland, WI
Stryker Sustainability Solutions
Class II Terminated
Reprocessed Electrophysiology Catheter Cables Catalog Number: CB3434CT, D134401, CB3410CT, CB3412CT Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on...
Reason: A breach in the sterile packaging may have occurred resulting in potentially non-sterile product.
Z-0964-2017 January 18, 2017 Tempe, AZ
ICU Medical, Inc.
Class II Terminated
Tego Connector, Item No. D1000, NM1000 The Tego¿ Needle Free Access Device is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an ...
Reason: ICU Medical Inc. has identified a potential risk of leaking with certain Tego Connector devices.
Z-0988-2017 January 18, 2017 San Clemente, CA
C.R. Bard, Inc.
Class II Terminated
SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device
Reason: The product contained a latex catheter instead of a silicone catheter.
Z-0967-2017 January 18, 2017 Covington, GA
Bard Access Systems
Class II Terminated
StatLock¿ PICC Plus Crescent Foam. Product Code: VPPCSP & VPPCSPCE. Packaged as a single unit with a skin protectant pad and foam strips in a Tyvek pouch. Depending on configuration, there are either...
Reason: Bard Access Systems announces a voluntary field action for the StatLock¿ Catheter Stabilization Devices because some single unit pouches have been released without unique product ...
Z-0981-2017 January 18, 2017 Salt Lake City, UT
ICU Medical, Inc.
Class II Terminated
133" 60 Drop 24 Hour Primary Set w/2 Bravo24¿, 2 Gang 1o2¿ Manifold, Rotating Luer, 1 Ext, Item No. B59006 Product Usage: The intravascular administration set is a single use, sterile, non-pyrog...
Reason: ICU Medical Inc. has identified an isolated event involving a 15 drop drip chamber assembled on a device which should contain a 60 drop drip chamber.
Z-0980-2017 January 18, 2017 San Clemente, CA
Bard Access Systems
Class II Terminated
StatLock¿ CV Plus w/Pigtail. Product Code: CV0220CE & CV0220. Packaged as a single unit with a skin protectant pad and foam strips in a Tyvek pouch. Depending on configuration, there are either 25 or...
Reason: Bard Access Systems announces a voluntary field action for the StatLock¿ Catheter Stabilization Devices because some single unit pouches have been released without unique product ...
Z-0982-2017 January 18, 2017 Salt Lake City, UT
Stryker Sustainability Solutions
Class II Terminated
Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT, CR3434CT Ablation catheter cables are designed as electrode cables with a multi-pin connector on the distal end which connects to an a...
Reason: A breach in the sterile packaging may have occurred resulting in potentially non-sterile product.
Z-0963-2017 January 18, 2017 Tempe, AZ
Oscor, Inc.
Class II Terminated
OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM Catalog # AB081211 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal ...
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Z-0799-2017 December 28, 2016 Palm Harbor, FL
Oscor, Inc.
Class II Terminated
OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal pun...
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Z-0790-2017 December 28, 2016 Palm Harbor, FL
Oscor, Inc.
Class II Terminated
OSCOR ADELANTE BREEZEWAY 8F C90¿ S61CM D66CM Catalog # AB081042 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal pun...
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Z-0792-2017 December 28, 2016 Palm Harbor, FL
Angiodynamics, Inc.
Class III Terminated
ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catalog No.REF 06597103 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a s...
Reason: Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the poten...
Z-0778-2017 December 28, 2016 Queensbury, NY
Oscor, Inc.
Class II Terminated
OSCOR ADELANTE BREEZEWAY 8F C70¿ S79CM D84CM Catalog # AB081045 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal pun...
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Z-0795-2017 December 28, 2016 Palm Harbor, FL
Oscor, Inc.
Class II Terminated
OSCOR BREEZEWAY 10F S60.8CM D65.6CM FIRM TIP Catalog # AB1061FT Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punct...
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Z-0810-2017 December 28, 2016 Palm Harbor, FL
Oscor, Inc.
Class II Terminated
OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB10218 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal...
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Z-0809-2017 December 28, 2016 Palm Harbor, FL
Oscor, Inc.
Class II Terminated
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120¿ S61CM D66CM GLOBAL Catalog # 990061-120-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the...
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Z-0814-2017 December 28, 2016 Palm Harbor, FL
Oscor, Inc.
Class II Terminated
OSCOR ADELANTE BREEZEWAY 10F C70¿ S61CM D66CM Catalog # AB101073 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal p...
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Z-0801-2017 December 28, 2016 Palm Harbor, FL
Medtronic Inc
Class II Terminated
ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. The PowerCross .018 OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infrapopli...
Reason: Medtronic identified an issue with specific models and lots of the PowerCross .018 Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter. During an u...
Z-0892-2017 December 28, 2016 Minneapolis, MN
Oscor, Inc.
Class II Terminated
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S79CM D84CM GLOBAL Catalog # 990079-070-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the...
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Z-0816-2017 December 28, 2016 Palm Harbor, FL
Oscor, Inc.
Class II Terminated
OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM D66CM Catalog # AB081210 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal...
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Z-0798-2017 December 28, 2016 Palm Harbor, FL
Oscor, Inc.
Class II Terminated
OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM D84CM Catalog # AB101219 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal...
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Z-0808-2017 December 28, 2016 Palm Harbor, FL
Oscor, Inc.
Class II Terminated
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Catalog # 990061-090-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the ...
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Z-0818-2017 December 28, 2016 Palm Harbor, FL
Oscor, Inc.
Class II Terminated
OSCOR ADELANTE BREEZEWAY 10F C70¿ S79CM D84CM Catalog # AB101077 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal p...
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Z-0804-2017 December 28, 2016 Palm Harbor, FL
Oscor, Inc.
Class II Terminated
OSCOR ADELANTE BREEZEWAY 10F C55¿ S79CM D84CM Catalog # AB101076 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal p...
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Z-0803-2017 December 28, 2016 Palm Harbor, FL