Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 105 of 138
ICU Medical, Inc.
Class II Terminated
TRIPLE PRESSURE KIT W/03ML FLUSH DEVICE FOR UNIV. OF IOWA, Item No. 46091-56 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces betwee...
Reason: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Z-0506-2017 November 23, 2016 San Clemente, CA
ICU Medical, Inc.
Class II Terminated
TRANSDUCER KIT W/30ML FLUSH DEVICE FOR CHILDRENS HOSP. OF WISC., Item No. 46063-11 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces ...
Reason: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Z-0464-2017 November 23, 2016 San Clemente, CA
Atrium Medical Corporation
Class II Terminated
Atrium Medical 12 Fr Trocar catheter, Sterile Model Number: 8412 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
Reason: Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
Z-0578-2017 November 23, 2016 Hudson, NH
ICU Medical, Inc.
Class II Terminated
TRANSPAC¿ IV MONITORING KIT WITH 2 SAFESET" BLOOD SAMPLING PORTS, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42620-08 The Transpac Disposable Straight Pr...
Reason: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Z-0442-2017 November 23, 2016 San Clemente, CA
ICU Medical, Inc.
Class II Terminated
Transpac¿ IV Kit w/2 3-Way Stopcocks and 48" Pressure TBG, Item No. 46112-77 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces betwe...
Reason: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Z-0564-2017 November 23, 2016 San Clemente, CA
ICU Medical, Inc.
Class II Terminated
Transpac¿ IV Monitoring Kit w/ Safeset" Reservoir and Blood Sampling Port, 03 ml Squeeze Flush Device, Macrodrip (Patient Mount), Item No. 46114-24 The Transpac Disposable Straight Pressure Transduc...
Reason: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Z-0568-2017 November 23, 2016 San Clemente, CA
ICU Medical, Inc.
Class II Terminated
Transpac¿ IV Trifurcated Monitoring Kit 84" w/03 ml Squeeze Flush Device, Red, Blue and Yellow Stripe Tubing, Item No. 46113-90 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extr...
Reason: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Z-0566-2017 November 23, 2016 San Clemente, CA
ICU Medical, Inc.
Class II Terminated
TRANSPAC¿ IV BIFURCATED MONITORING KIT 72 INCH, 2 DISPOSABLE TRANSDUCER, 2 3 ML INTRAFLO¿ FLUSHES, MACRODRIP (POLE MOUNT), Item No. 42651-05 The Transpac Disposable Straight Pressure Transducer (DS...
Reason: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Z-0450-2017 November 23, 2016 San Clemente, CA
ICU Medical, Inc.
Class II Terminated
CATH LAB KIT FOR BAPTIST M. C., Item No. 46078-52 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure m...
Reason: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Z-0488-2017 November 23, 2016 San Clemente, CA
SentreHeart Inc
Class I Terminated
FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the cardiovascular system for introduction and positioning of over the-wire catheters and therapeutic devi...
Reason: A complaint was received on September 27th, 2016 at a medical center in Germany for delamination and flaking of the PTFE lubricious coating on three FindrWIRZ Guidewire System .02...
Z-0328-2017 November 16, 2016 Redwood City, CA
Stryker Sustainability Solutions
Class II Terminated
Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters Model Numbers: 401940, 402004 UPC Code: 00885825007409 00885825007744 Diagnostic electrophys...
Reason: The EP Catheters may be mislabeled for French size during reprocessing.
Z-0380-2017 November 16, 2016 Tempe, AZ
C.R. Bard, Inc.
Class II Terminated
X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm, Product Code 996081 The product is a dual lumen catheter with a 24 (8mm) or 30Fr (10mm) balloon m...
Reason: Contract manufacturer packaged an incorrect sheath with the product. Packaged 30Fr instead of 24Fr.
Z-0363-2017 November 16, 2016 Covington, GA
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Class I Terminated
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion ...
Reason: Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.
Z-0309-2017 November 16, 2016 Irvine, CA
Epimed International, Inc.
Class II Terminated
15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia
Reason: There is a possibility that the needles may have the potential to skive a catheters outer coating. If this were to occur, there exists the risk that a portion of the catheter cou...
Z-0086-2017 November 9, 2016 Johnstown, NY
Stryker Neurovascular
Class II Terminated
Guider Softip XF; GUIDER/MP XF/8FR/100 cm, Model number: M003101480. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional de...
Reason: Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Z-0334-2017 November 9, 2016 Fremont, CA
Stryker Neurovascular
Class II Terminated
Guider Softip XF; GUIDER/MP XF/7FR/90CM, Model number: H965100470. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devi...
Reason: Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Z-0335-2017 November 9, 2016 Fremont, CA
Medtronic Navigation, Inc.
Class II Terminated
Visualase Body Accessory Kit PN 020-3000. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches. The packaged devices are then placed into a cardboard box wh...
Reason: Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Stylets and Visualase Body Accessory Kit because when the Visualization Stylet is plac...
Z-0323-2017 November 9, 2016 Louisville, CO
Stryker Neurovascular
Class II Terminated
Guider Softip XF; GUIDER/40 DEG XF/7FR/100 cm, Model number: M003101430 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of intervention...
Reason: Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Z-0342-2017 November 9, 2016 Fremont, CA
Arrow International Inc
Class II Terminated
HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed in a contamination shield (Arrow Cath-Gard) with integral flushing/balloon test chamber, ena...
Reason: Labeling inconsistency
Z-0331-2017 November 9, 2016 Reading, PA
Stryker Neurovascular
Class II Terminated
Guider Softip XF; GUIDER MPXF 5F 100CM, Model number: M003101630. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devic...
Reason: Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Z-0339-2017 November 9, 2016 Fremont, CA
Stryker Neurovascular
Class II Terminated
Guider Softip XF; GUIDER/40 DEG XF/6FR/100 cm, Model number: M003101420. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventiona...
Reason: Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Z-0340-2017 November 9, 2016 Fremont, CA
Stryker Neurovascular
Class II Terminated
Guider Softip XF; GUIDER 40XF 5F 90CM, Model number:M003100620 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional device...
Reason: Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Z-0347-2017 November 9, 2016 Fremont, CA
Stryker Neurovascular
Class II Terminated
Guider Softip XF; GUIDER/40DEG XF/6FR/90CM, Model number: H965100420. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional d...
Reason: Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Z-0338-2017 November 9, 2016 Fremont, CA
Stryker Neurovascular
Class II Terminated
Guider Softip XF; GUIDER/MP XF/6FR/90CM, Model number: H965100460. Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devi...
Reason: Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Z-0336-2017 November 9, 2016 Fremont, CA
Stryker Neurovascular
Class II Terminated
Guider Softip XF; GUIDER/40XF/8FR/90CM, Model number: H965100440 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devi...
Reason: Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Z-0341-2017 November 9, 2016 Fremont, CA