Datascope Corporation Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06. It is an accessory to be used for percutaneous insertion of MAQUET Intra Aortic Balloon Catheters. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.

Recommended Action

Per FDA guidance

On December 11, 2019 the firm distributed Urgent Medical Device Recall Communication letters by FedEx 2 day delivery with signature proof of delivery stating: URGENT MEDICAL DEVICE RECALL REMOVAL MAQUET 7Fr., 7.5Fr. and 8Fr. REINFORCED INTRODUCER SETS PLEASE FORWARD THIS INFORMATION TO ALL CURRENT AND POTENTIAL USERS OF REINFORCED INTRODUCER SETS FOR MAQUET 7 Fr., 7.5 Fr. AND 8 Fr. INTRA-AORTIC BALLOON (IAB) WITHIN YOUR HOSPITAL OR FACILITY. IF YOU HAVE FURTHER DISTRIBUTED ANY OF THE AFFECTED PRODUCTS, FORWARD THIS INFORMATION TO THE RECIPIENT. Dear Risk Manager, Datascope / Maquet Getinge is initiating a voluntary Medical Device Recall Removal of the Reinforced Introducer Sets for Maquet 7 Fr., 7.5 Fr.and 8 Fr. IAB (Intra Aortic Balloon) due to a potential breach in the Mylar side (clear plastic) of the pouch, which could compromise device sterility. Identification of the issue: During the execution of a remediation protocol for re-verification of packaging, Datascope / Maquet Getinge found a small slit on the Mylar side (clear plastic) of the pouch of one device. Imprints of the sharp corners of the polystyrene strip used in packaging were observed around the slit, which likely caused the breach in the pouch compromising the sterility of the device. Risk to Health Adequate packaging and packaging materials are essential to help preserve the sterility of medical devices. Improperly sterilized medical devices may pose a serious risk of patient infection, including pyrogenic reaction, inflammatory response, and the possibility of a deadly infection. The probability of serious injury or illness occurring as a result of this potential issue is unlikely, however, likelihood is greater for immunocompromised patients. To date, Datascope / Maquet Getinge has not received any complaints, nor have any adverse events been reported resulting in serious illness or injuries caused by the Reinforced Introducer Set for Maquet 7 Fr., 7.5 Fr.

Distribution

As reported by FDA

AL, AK, AZ, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MI, MN, MS, MO, NE, NJ, NY, NC, ND, OH, OK, PA, SC, SD, TN, TX, VA, WA, WV, WI