Recall Z-2614-2016— Cook Inc.

Name: FDA recall Z-2614-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-15

Class II · Terminated

Class II FDA medical device recall by Cook Inc., initiated 2016-04-15, terminated 2017-08-04. It names one FDA 510(k) clearance: K122937. Product: Slip-Cath Beacon Tip Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques.. Reason: Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs..

Recalling firm: Cook Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-04-15
Terminated: 2017-08-04
Firm location: Bloomington, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K122937 — SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX)Cook, Inc.·cleared 2012-12-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Slip-Cath Beacon Tip Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques.

Reason for recall

Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

Data sourced from openFDA. This site is unofficial and independent of the FDA.