Z-0934-2020Class II

Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an accessory to be used for...

Name: Z-0934-2020 Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an accessory to be used for...
Creator: Datascope Corporation
Published: 2019-11-20
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2019-11-20 / Terminated / root cause: packaging

FDA source

Datascope Corporation began a recall of Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic Balloon... on 2019-11-20. FDA classified it as Class II and gives the reason as "Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0934-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-20
Posted: 2020-02-02
Terminated: 2021-06-15
Recalling firm: Datascope Corp.
Product: Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic Balloon Catheters.
Product code: DSP System, Balloon, Intra-Aortic And Control
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.
Root cause tag: packaging
FDA root cause: 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: 523
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
Product codes and lots: Part Number: 068400040310 UDI: 10607567107943 (068400040310) Lot Codes: 3000079612, 3000043101, 3000036631, 3000015016, TTP.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0934-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0932-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-01
Z-0933-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-01
Z-0934-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-01

Product code DSP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)