FDA Device recall Z-2557-2014

Cordis EMPIRA RX PTCA Dilatation Catheter

FDA Device
Class II
terminated
Published 2014-09-03

On 2014-09-03 the FDA classified a Class II recall of Cordis EMPIRA RX PTCA Dilatation Catheter by Cordis, citing the balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2557-2014
Classification	Class II
Status	terminated
Initiated	2014-06-23
Published	2014-09-03
Last updated	2026-09-13 11:53 UTC
Company	Cordis
Distribution	AR, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WV, WY

Product

Cordis EMPIRA RX PTCA Dilatation Catheter

Reason

The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover. This may lead to balloon burst, shaft separation or deflation difficulties, which could result in procedural delay, vessel trauma or surgery.

Identifiers

code_info	70 Catalog numbers: 85R06150S, 85R06200S, 85R06225S, 85R06250S, 85R06275S, 85R06300S, 85R06325S, 85R06350S, 85R0637… 70 Catalog numbers: 85R06150S, 85R06200S, 85R06225S, 85R06250S, 85R06275S, 85R06300S, 85R06325S, 85R06350S, 85R06375S, 85R06400S, 85R10150S, 85R10200S, 85R10225S,85R10250S, 85R10275S, 85R10300S, 85R10325S, 85R10350S, 85R10375S, 85R10400S, 85R12150S, 85R12200S, 85R12225S, 85R12250S, 85R12275S, 85R12300S, 85R12325S, 85R12350S, 85R12375S, 85R12400S, 85R15150S, 85R15200S, 85R15225S, 85R15250S, 85R15275S, 85R15300S, 85R15325S, 85R15350S, 85R15375S, 85R15400S, 85R20150S, 85R20200S, 85R20225S, 85R20250S, 85R20275S, 85R20300S, 85R20325S, 85R20350S, 85R20375S, 85R20400S, 85R25150S, 85R25200S, 85R25225S, 85R25250S, 85R25275S, 85R25300S, 85R25325S, 85R25350S, 85R25375S, 85R25400S, 85R30150S, 85R30200S, 85R30225S, 85R30250S, 85R30275S, 85R30300S 85R30325S, 85R30350S, 85R30375S, and 85R30400S.

code_info

70 Catalog numbers: 85R06150S, 85R06200S, 85R06225S, 85R06250S, 85R06275S, 85R06300S, 85R06325S, 85R06350S, 85R0637…

70 Catalog numbers: 85R06150S, 85R06200S, 85R06225S, 85R06250S, 85R06275S, 85R06300S, 85R06325S, 85R06350S, 85R06375S, 85R06400S, 85R10150S, 85R10200S, 85R10225S,85R10250S, 85R10275S, 85R10300S, 85R10325S, 85R10350S, 85R10375S, 85R10400S, 85R12150S, 85R12200S, 85R12225S, 85R12250S, 85R12275S, 85R12300S, 85R12325S, 85R12350S, 85R12375S, 85R12400S, 85R15150S, 85R15200S, 85R15225S, 85R15250S, 85R15275S, 85R15300S, 85R15325S, 85R15350S, 85R15375S, 85R15400S, 85R20150S, 85R20200S, 85R20225S, 85R20250S, 85R20275S, 85R20300S, 85R20325S, 85R20350S, 85R20375S, 85R20400S, 85R25150S, 85R25200S, 85R25225S, 85R25250S, 85R25275S, 85R25300S, 85R25325S, 85R25350S, 85R25375S, 85R25400S, 85R30150S, 85R30200S, 85R30225S, 85R30250S, 85R30275S, 85R30300S 85R30325S, 85R30350S, 85R30375S, and 85R30400S.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2557-2014%22

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