Search Results for: catheter

Penumbra Recalls the Original Version of 6F Neuron 070 Delivery Catheter

October 1, 2009 By The FDA Leave a Comment

Penumbra is initiating a voluntary Field Removal of the original version of Neuron 6F 070 Delivery Catheter. For these catheters, Penumbra has received feedback from some users that the catheter could kink or ovalize in certain anatomical situations. This kinking and/or ovalization of the catheter lumen can lead to difficulty in catheter … [Read more...]

Penumbra Neuron 5F Select Catheter

September 12, 2009 By The FDA Leave a Comment

Penumbra and FDA notified healthcare professionals of the Class 1 recall of the Neuron 5F Select Catheter, used to remove blood clots or foreign objects from blood vessels. Due to a manufacturing error, the catheters may contain pin holes and exposed wire braids which may result in a brain clot or a blood vessel puncture, and this may lead to … [Read more...]

Abbott Issues Voluntary Recall of POWERSAIL Coronary Dilatation Catheters

July 31, 2009 By The FDA Leave a Comment

Abbott has conducted a voluntary recall of three lots of POWERSAIL® Coronary Dilatation Catheters from United States distribution and one lot from international distribution as a result of four complaints (one from each lot) that the distal shaft of the catheter exhibited damage. While the issue could be detected and avoided during the preparation … [Read more...]

Arrow International Announces Worldwide Voluntary Recall of Intra Aortic Balloon Pump (IAB) Catheters

April 17, 2009 By The FDA Leave a Comment

TELEFLEX MEDICAL ANNOUNCED THAT THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) HAS CLASSIFIED THE VOLUNTARY MEDICAL DEVICE RECALL INITIATED ON FEBRUARY 2, 2009 BY ARROW INTERNATIONAL'S CARDIAC CARE DIVISION INVOLVING VOLUME CONNECTORS FOR ITS 30CC, 40CC AND 50CC INTRA AORTIC BALLOON PUMP (IAB) CATHETERS AS A CLASS 1 RECALL. FDA DEFINES CLASS I RECALLS … [Read more...]

Class I Recall of Intra Aortic Balloon Pump (IAB) Catheters by Arrow International

April 15, 2009 By The FDA Leave a Comment

CONTACT: INVESTORS:&NBSP;&NBSP;JAKE ELGUICZE&NBSP;&NBSP; 610-948-2836 MEDIA:&NBSP;&NBSP;&NBSP;&NBSP;JULIE MCDOWELL &NBSP;&NBSP; 610-948-2829 TELEFLEX MEDICAL ANNOUNCED TODAY THAT THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) HAS CLASSIFIED THE VOLUNTARY MEDICAL DEVICE RECALL INITIATED ON FEBRUARY 2, 2009 BY ARROW INTERNATIONAL’S CARDIAC CARE … [Read more...]