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Class 2 Device Recall Datascope / Maquet Getinge Reinforced Introducer Sets |
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| Date Initiated by Firm |
November 20, 2019 |
| Create Date |
February 02, 2020 |
| Recall Status1 |
Terminated 3 on June 15, 2021 |
| Recall Number |
Z-0933-2020 |
| Recall Event ID |
84521 |
| Product Classification |
System, balloon, intra-aortic and control - Product Code DSP
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| Product |
Reinforced Introducer Sets Maquet 7.5 Fr., Part Number: 068400040305. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic Balloon Catheters. |
| Code Information |
Part Number: 068400040305 UDI: 10607567106694 (068400040305) Lot Codes: 3000040290, 3000086802, 3000031711, 3000079613, 3000019781, 3000053099, 3000014728, 3000043100, TTQ. |
Recalling Firm/
Manufacturer |
Datascope Corporation
15 Law Dr
Fairfield NJ 07004-3206
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| For Additional Information Contact |
Rachana Patel
973-709-7412
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Manufacturer Reason
for Recall |
Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.
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FDA Determined
Cause 2 |
Package design/selection |
| Action |
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. |
| Quantity in Commerce |
676 |
| Distribution |
US: AK AL AZ CA CO CT FL GA IA ID IL IN KS KY LA MD MI MN MO MS NC ND NE NJ NY OH OK PA SC SD TN TX VA WA WI WV
OUS: Switzerland, Netherlands, South Africa, Canada, Germany, Austria, Spain, Italy, Poland, Bharain, Malaysia |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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