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Terminated

Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Catheter. The Arrow Berman(TM) Angiographic Catheter is indicated for use in right heart catheterization for cardiac angiography, and measurement of the right heart and pulmonary artery pressures. It can be sued to inject radiopaque media and measure pressures in any chamber or vessel that can be entered from the right heart. The Arrow Berman(TM) Angiographic Catheter is also indicated for use in Balloon Occlusion Femoral Angiography (BOFA) of the ipsilateral leg for adult patients. The Arrow Reverse Berman(TM) Angiographic Catheter is indicated for balloon occlusion pulmonary angiography.

FDA Recall Z-1057-2013 · Posted 2013-04-04

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeDYG
Date Initiated2013-03-04
Date Terminated2013-12-21
Product Quantity99627ea

Reason for Recall

The product specifications sheet, part of the Instructions for Use (IFU), for the specified product numbers, reference Renografin-76 contrast medium (viscosity of 8.4 centipoise), which is no longer available. Firm is in the process of updating the labeling for these products. In the meantime, when choosing an alternative contrast medium, health care providers are instructed to select a contrast

Firm Action

Arrow sent an Urgent Medical Device Customer Notification letter dated March 4, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Arrow is in the process of updating the labeling; in the meantime they wanted to instruct all customers to select a contrast medium with a viscosity of 8.4 centipoise or lower for use with the pressure and flow settings specified in the current IFU. In addition, they are placing an insert card in kits for the specified product codes alerting them that Renografin-76 is no longer available and to select a contract medium with a viscosity of 8/4 centipose or lower for use with the pressure and flow setting specified in the current IFU. Arrow remains committed to providing high quality, safe and effective products. If you require additional information or clarification regarding this matter, please contact your Sales Representative or Arrow's Customer Service Department at (866) 396-2111.

Root Cause

Labeling Change Control

Distribution Pattern

Worldwide Distribution - USA including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV. and the countries of Australia, Dominican Republic, Uruguay, Ecuador, Chile, Taiwan, Pakistan, Colombia, Argentina, Korea Republic, New Zealand, Guatemala, Thailand, Peru, Bahamas, Philippines, Trinidad and Tobago, Japan, Ireland, India, Singapore, China, Canada and Mexico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K892530CATHETERS FOR BALLOON OCCLUSION FEMORAL ANGIOGRAPHArrow Intl., Inc. · 1989-09-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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