Recalls / —

—#134136

Product

Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS

FDA product code

DSP — System, Balloon, Intra-Aortic And Control

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K021462

Affected lot / code info

Lot Number: KF1111796 Exp. Date: 11/30/2013

Why it was recalled

Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere.

Root cause (FDA determination)

Process control

Action the firm took

Arrow International Inc notified accounts by letter dated 11/8/13 describing the problem and requested users to immediately discontinue use and return product. A Recall Acknowledgement form was to be completed and returned.

Recalling firm

Firm

Arrow International Inc

Address

2400 Bernville Rd, Reading, Pennsylvania 19605-9607

Distribution

Distribution pattern

Distribution US nationwide (including AZ, NJ, ME, TX, WA), and Germany.

Timeline

Recall initiated

2013-11-08

Posted by FDA

2015-03-10

Terminated

2015-03-16

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #134136. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.